Phase 1 of Integrated EMDR An Abortive Treatment for Migraine Headaches

2008 ◽  
Vol 2 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Steven V. Marcus
Keyword(s):  
Standard Care ◽  
Phase 1 ◽  
Migraine Treatment ◽  
Comparison Standard ◽  
Eye Movement Desensitization Reprocessing ◽  
Medication Treatment ◽  
Treatment Groups ◽  
Migraine Headaches ◽  
Migraine Pain ◽  
Independent Evaluator

Forty-three individuals diagnosed with classic or common migraine headache were randomly assigned to either phase 1 of integrated eye movement desensitization reprocessing (EMDR) treatment or a standard care medication treatment. Integrated EMDR combines diaphragmatic breathing, cranial compression, and EMDR for abortive migraine treatment. The comparison standard care medication group received various abortive medications, including Demerol, DHE, oral triptans, Excedrin, Fiorinal, Percocet, Toradol, and Vicodin. Participants were treated during mid- to late-stage acute migraine and assessed by an independent evaluator at pretreatment, posttreatment, 24 hours, 48 hours, and 7 days for migraine pain level. Both standard care medication and integrated EMDR treatment groups demonstrated reduced migraine pain levels immediately at posttreatment, 24 hours, 48 hours, and 7 days. However, integrated EMDR treatment reduced or eliminated migraine pain with greater rapidity and showed significantly greater improvement compared to standard care medication immediately posttreatment.

Telemedicine for Patients with Inflammatory Bowel Disease (TELE-IBD) Clinical Trial: Qualitative Assessment of Participants’ Perceptions of the TELE-IBD Intervention (Preprint)

2019 ◽  
Author(s):  
Charlene C Quinn ◽  
Sarah Chard ◽  
Erin G Roth ◽  
J. Kevin Eckert ◽  
Katharine M Russman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Disease Activity ◽  
Remote Monitoring ◽  
Standard Care ◽  
Disease Process ◽  
The United States ◽  
Qualitative Assessment ◽  
Structured Interviews ◽  
Treatment Groups ◽  
Inflammatory Bowel

BACKGROUND Inflammatory bowel diseases (IBD), comprising Crohn’s disease and ulcerative colitis, affects 1 to 3 million people in the United States. Telemedicine has shown promise in IBD. The objective of the parent study, TELE-IBD, was to compare disease activity and quality of life (QoL) in a one-year randomized clinical trial of IBD patients receiving telemedicine versus standard care. Treatment groups experienced improvements in disease activity and QoL but there was not significant differences between groups. Study adherence to the text-based intervention was less than the 80% of the targeted goal. OBJECTIVE To understand adherence to remote monitoring, the goal of this qualitative assessment was to obtain TELE-IBD trial participants’ perceptions of the TELE-IBD system, including their recommendations for future TELE-IBD monitoring. METHODS In the parent study, patients attending three tertiary referral centers with worsening IBD symptoms in the previous two years were eligible for randomization to remote monitoring via texts every other week (EOW), weekly (W) or standard care. Participants (n=348) were evenly enrolled in the treatment groups and 259 (74.4%) completed the study. For this study, a purposive sample of adherent (N=15) and non-adherent (N=14) patients was drawn from the TELE-IBD trial population. Adherence was defined as the completion of 80% or more of the W or EOW self-assessments. Semi-structured interviews conducted by phone surveyed 1) the strengths and benefits of TELE-IBD; 2) challenges associated with using TELE-IBD; and 3) how to improve the TELE-IBD intervention. Interviews were recorded, professionally transcribed, and coded based on a priori concepts and emergent themes with the aid of ATLAS.ti qualitative data analysis software. RESULTS Participants' discussions centered on three elements of the intervention: 1) self-assessment questions, 2) action plans, and 3) educational messages. Participants also commented on: text-based platform, depression and adherence, TELE-IBD system in place of office visit, and their recommendations for future TELE-IBD systems. Adherent and non-adherent participants prefer a flexible system that is personalized, including targeted education messages, and they perceive TELE-IBD as effective in facilitating IBD self-management. CONCLUSIONS Participants identified clear benefits to the TELE-IBD system, including obtaining a better understanding of the disease process, monitoring their symptoms, and feeling connected to their health care provider. Participants' perceptions obtained in this qualitative study will assist in improving the TELE-IBD system to be more responsive to patients with IBD. CLINICALTRIAL NCT01692743

Current understanding of premonitory networks in migraine: A window to attack generation

Cephalalgia ◽  
2019 ◽  
Vol 39 (13) ◽  
pp. 1720-1727 ◽  
Author(s):  
Laura H Schulte ◽  
Kuan-Po Peng
Keyword(s):  
Sleep Disturbances ◽  
Integration Site ◽  
Basic Research ◽  
Rostral Ventromedial Medulla ◽  
Spinal Trigeminal Nucleus ◽  
Migraine Headaches ◽  
Migraine Pain ◽  
Ventromedial Medulla ◽  
External Stimuli ◽  
Premonitory Symptoms

Aim To describe neuronal networks underlying commonly reported migraine premonitory symptoms and to discuss how these might precipitate migraine pain. Background Migraine headache is frequently preceded by a distinct and well characterized premonitory phase including symptoms like yawning, sleep disturbances, alterations in appetite and food intake and hypersensitivity to certain external stimuli. Recent neuroimaging studies strongly suggest the hypothalamus as the key mediator of the premonitory phase and also suggested alterations in hypothalamic networks as a mechanism of migraine attack generation. When looking at the vast evidence from basic research within the last decades, hypothalamic and thalamic networks are most likely to integrate peripheral influences with central mechanisms, facilitating the precipitation of migraine headaches. These networks include sleep, feeding and stress modulating centers within the hypothalamus, thalamic pathways and brainstem centers closely involved in trigeminal pain processing such as the spinal trigeminal nucleus and the rostral ventromedial medulla, all of which are closely interconnected. Conclusion Taken together, these networks represent the pathophysiological basis for migraine premonitory symptoms as well as a possible integration site of peripheral so-called “triggers” with central attack facilitating processes.

scholarly journals Comparison of efficacy and safety of three drugs levetiracetam, sodium valproate, and nortriptyline in the prevention of migraine headache

2020 ◽  
pp. 336-343
Keyword(s):  
Sodium Valproate ◽  
Severe Headache ◽  
Migraine Treatment ◽  
Chi Square ◽  
Migraine Headaches ◽  
Neurology Clinic ◽  
Quasi Experimental ◽  
The Mean ◽  
Acute Attacks ◽  
Mild Headache

Background and Aim: Headache is the most common cause of referral to a physician. Two approaches of the migraine treatment include: treat the acute attacks and prevent future attacks. In this regard, the aim of this study was to investigate the effect of three drugs lutiracetam, sodium valproate and nortriptyline in the control of migraine headaches in patients with migraine in Birjand Neurology Clinic. Materials and Methods: This study is a quasi-experimental study. According to the physician, 120 migraine patients were divided into one of three groups: Lutiracetam with a daily dose of 250 mg, sodium valproate 500 mg and nortriptyline 25 mg for 4 weeks. Patientschr('39') information was collected through a questionnaire. Then the data were analyzed by SPSS) Version 16) software by using chi-square, paired t-test, and ANOVA. Results: 120 patients were divided into three groups of 40 patients. The mean age of the subjects was 33±11 years, 53.3% of them were female and 46.7% of them were male. In total, 46.7% of patients had severe headache before taking these three drugs. None of them had severe headache after taking the drug and 77.5% of them had mild headache. Lutiracetam group showed the greatest decrease in headache intensity. (P=0.01). Conclusion: Levetiracetam appears to be more effective than the other two drugs, especially sodium valproate, in reducing different degrees of headache.

Sumatriptan nasal spray for the acute treatment of migraine

Neurology ◽  
1997 ◽  
Vol 49 (5) ◽  
pp. 1225-1230 ◽  
Author(s):  
R. Ryan ◽  
A. Elkind ◽  
C. C. Baker ◽  
W. Mullican ◽  
S. DeBussey ◽  
...  
Keyword(s):  
Adverse Events ◽  
Migraine Attack ◽  
Nasal Spray ◽  
Acute Treatment ◽  
International Headache Society ◽  
Migraine Treatment ◽  
Multicenter Studies ◽  
Double Blind ◽  
Treatment Groups ◽  
Migraine Medication

Background: Sumatriptan nasal spray may be particularly useful for patients whose nausea and vomiting preclude them from using oral migraine medication or for patients who prefer not to use an injectable migraine medication. The objective of this study was to evaluate in two clinical studies the efficacy and tolerability of the intranasal form of sumatriptan in the acute treatment of a single migraine attack. International Headache Society-diagnosed adult migraineurs in two randomized, double-blind, parallel-group, multicenter studies (n = 409 and 436) used sumatriptan nasal spray 20 mg, 10 mg, or placebo (2:1:1) for the acute treatment of a single migraine attack at home. Predose and at predetermined postdose intervals, patients recorded headache severity (none, mild, moderate, severe); time to meaningful relief; clinical disability (none, mildly impaired, severely impaired, bed rest required); presence/absence of nausea, photophobia, and phonophobia; and the occurrence of adverse events. Two hours postdose in the two studies, moderate or severe baseline pain was reduced to mild or none in 62 to 63% of patients treated with sumatriptan 20 mg, 43 to 54% of patients treated with sumatriptan 10 mg, and 29 to 35% of placebo-treated patients (p < 0.05 20 mg versus placebo for both studies and 10 mg versus placebo for study 1). Onset of relief relative to placebo began as early as 15 minutes postdose(sumatriptan 20 mg, study 2). Clinical disability at 2 hours postdose was reported as mildly impaired or normal in 72 to 74% of patients treated with sumatriptan 20 mg, 56 to 68% of patients treated with sumatriptan 10 mg, and 47 to 58% of placebo-treated patients (p < 0.05 20 mg versus placebo for both studies). Similar efficacy rates were observed for nausea, photophobia, and phonophobia. The most common adverse event in the active treatment groups was disturbance of taste (bad, bitter, or unpleasant taste). Aside from this event, the pattern and incidence of adverse events did not differ among treatment groups. From these results we determined that sumatriptan nasal spray is a rapidly effective, well-tolerated migraine treatment. The 20-mg dose was effective in treating the entire migraine symptom complex, and the 10-mg dose was less consistently effective.

Relocation does not have a significant effect on the growth rate of Bos indicus cross steers

2008 ◽  
Vol 48 (5) ◽  
pp. 608 ◽  
Author(s):  
R. G. Holroyd ◽  
V. J. Doogan ◽  
M. R. Jeffery ◽  
J. A. Lindsay ◽  
B. K. Venus ◽  
...  
Keyword(s):  
Growth Rate ◽  
Phase 1 ◽  
Bos Indicus ◽  
Poor Performance ◽  
The Other ◽  
Control Group ◽  
Phase 2 ◽  
Treatment Groups ◽  
Normal Ranges ◽  
Native Pastures

This experiment tested the hypothesis that relocating cattle is detrimental to their growth. The study examined the effect of having relocated cattle mixed with, or segregated from, the local acclimatised cattle at the destination property. Bos indicus cross steers (120) were allocated to three groups and were relocated, in two separate cohorts, 980 km from northern Queensland to improved pastures in central Queensland. At the start of Phase 1, the control group (C) was moved 3 months before the other two groups. The remaining two groups grazed native pastures; one group was supplemented (SR) to increase growth rate similar to that expected from improved pasture in central Queensland and the other was not supplemented (R). At the end of Phase 1, C was significantly (P < 0.05) heavier than SR, which was significantly (P < 0.05) heavier than R. At the start of Phase 2, the SR and R groups were relocated and after transportation the R and SR groups lost 12 kg or 4.4% of liveweight and 18 kg or 5.7% of liveweight, respectively; this weight loss was recovered after 5 days. All steers were reallocated to segregated (SEG) or mixed (MIX) treatment groups forming six treatments (SEG.C, SEG.R and SEG.SR and MIX.C, MIX.R and MIX.SR). There were no significant differences in liveweights within the SEG treatments by 57 days or within the MIX treatments by 106 days after relocation. There were few if any significant differences in the plasma constituents and differential leucocyte counts of the steers and most results were within physiologically normal ranges. We conclude on the basis of these results and of other experiments that the anecdotal poor performance of cattle after relocation appears to be unfounded.

A Randomized, Placebo-Controlled, Dose-Escalation, Phase 1 Study of the Safety and Pharmacokinetics of Amphotericin B Inhalation Powder in Healthy Subjects.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4988-4988
Author(s):  
Annette Marcantonio ◽  
Alan R. Kugler ◽  
David Sahner ◽  
Nina Mufti ◽  
Jonathan D. Lee ◽  
...  
Keyword(s):  
Amphotericin B ◽  
Treatment Period ◽  
Healthy Subjects ◽  
Renal Toxicity ◽  
Fungal Infections ◽  
Large Fraction ◽  
Phase 1 ◽  
Exertional Dyspnea ◽  
Treatment Groups ◽  
Inhalation Powder

Abstract Nektar is developing Amphotericin B Inhalation Powder (ABIP; NKTR-024) to prevent invasive pulmonary fungal infections in immunocompromised patients. NKTR-024 is a proprietary dry-powder amphotericin B (AmB) formulation that is delivered to the patient’s respiratory tract with a proprietary breath-actuated inhalation device (T-326). This study assessed 1) the safety and tolerability and 2) the pharmacokinetics (PK) of AmB in epithelial lining fluid (ELF) and plasma after a loading dose (LD) and 4 weekly maintenance doses (MD) of NKTR-024 in healthy subjects. Thirty-six (36) subjects enrolled in a single center in the US into 2 cohorts 2:1 to receive either NKTR-024 (n=12) or a matching (powder load) placebo inhalation powder (n=6), respectively. Subjects in Cohort 1 (Coh1) received a 25-mg LD and 4 weekly 5-mg MD (25/5) and subjects in Cohort 2 (Coh2) received a 50-mg LD and 4 weekly 10-mg MD (50/10) of NKTR-024 or placebo, respectively. PK assessments used blood [plasma] and bronchoalveolar lavage (BAL) [ELF] samples. Concomitant medications, adverse events (AEs) and other safety parameters were monitored for 17 wk (screening period of up to 28 d, a 4-wk treatment period, and a 9-wk post-treatment period). All 36 subjects received 1 LD and 4 MDs. Subjects were mostly male (n=24, 66.7%) and Caucasian (n=27, 75%). Mean age=28.1 yr, median height=175.3 cm and median weight=77.4 kg. PK data have been previously presented and will not serve as the focus of this abstract. Maximal plasma AmB concentrations occurred at ∼8–12 hr postdose following a ∼1 hr postdose lag. Plasma AmB concentrations (<54.6 ng/mL after the 50-mg NKTR-024 LD) remained well below those typically associated with renal toxicity (plasma AmB concentrations of ≥1000 ng/mL). Mean lung ELF AmB concentrations from the first BAL samples (∼4 hr) were 70.7 and 189 μg/mL for Coh1 and Coh2, respectively. These high lung ELF AmB concentrations show that a large fraction of the nominal NKTR-024 doses were delivered to the lung. Both the NKTR-024 regimens (25/5 and 50/10) were well-tolerated. AEs were mild or moderate. No serious AEs occurred. Most of the AEs across treatment groups were related to bronchoscopy or “other” reasons. Respiratory AEs were most common across treatment groups. Slightly more respiratory AEs (cough, productive cough, increased bronchial secretions, wheezing, dyspnea, and exertional dyspnea) occurred in the NKTR-024 groups versus the placebo groups. AEs were greatest on the day of dosing and for the first 2 days after dosing. Hematology, chemistry, and urinalysis showed no clinically concerning treatment-induced toxicity. No clinically significant abnormalities were noted on physical examination, vital signs, chest x-ray, or electrocardiogram. Spirometry (FVC and FEV1) remained virtually unchanged from predose to postdose at all scheduled visits except for 4 subjects who had transient declines in FVC or FEV1 >20% temporally related to bronchoscopy. Repeated administration of NKTR-024 resulted in high pulmonary and low systemic AmB exposure. Plasma AmB concentrations were well below those associated with renal toxicity; this observation supports an important potential benefit of the NKTR-024 investigational product. Constitutional symptoms and electrolyte abnormalities traditionally seen with systemic administration of AmB were essentially spared.

scholarly journals Stenosis Outcome at 1 and 3 Years after Transplantation Vs Standard-Care in Children with Sickle-Cell Anemia and Abnormal Transcranial Doppler with Stroke or No-Stroke History

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2271-2271
Author(s):  
Suzanne Verlhac ◽  
Catherine Paillard ◽  
Flaviu Gabor ◽  
Charlotte Jubert ◽  
Jean-Francois Chateil ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Standard Care ◽  
Internal Carotid ◽  
Prospective Trial ◽  
Advisory Board ◽  
Care Group ◽  
Standard Care Group ◽  
Advisory Committees ◽  
Treatment Groups ◽  
History Of

The presence of cerebral macrovasculopathy as detected by transcranial Doppler (TCD) exposes children with sickle cell anemia (SCA) to a high risk of stroke, preventable by chronic transfusion or stem cell transplantation (SCT). However, long-term outcomes of stenosis have not been well described. The Drepagreffe trial (NCT01340404) was a prospective trial comparing cerebral vasculopathy outcome after SCT vs standard-care in children with abnormal TCD with or without stroke history. Results from the whole population have recently been reported (Bernaudin et al, JAMA 2019). The decrease in velocities was significantly higher after SCT than standard-care (p<0.001) at 1 and 3-year, but the stenosis score was not different between both treatment groups. The aim of the present study was to determine stenosis outcome as a function of stroke or no-stroke history in both treatment groups using detailed post-hoc analysis. Sixty-seven SCA-children on chronic transfusion for abnormal-TCD history were enrolled (Dec-2010/June-2013) in this prospective trial with two treatment groups defined by the random-availability of having a matched-sibling donor (MSD). Thirty-two with MSD were transplanted while 35 without MSD were maintained on chronic transfusion for at least one-year and eventually switched to hydroxyurea thereafter if no stenosis and normalized velocities. Cerebral and cervical magnetic-resonance angiography (MRA) was systematically performed at enrollment, and 1- and 3-year post-enrollment. Stenosis was defined as a narrowing ≥25%. The MRA stenosis-score, was calculated as the weighted sum of the scores in the 8 assessed cerebral arteries (right and left middle cerebral (MCA), anterior (ACA), internal carotid (ICA) and extracranial internal carotid arteries (eICA)), with 0 = stenosis, 1 = mild stenosis (25-49%), 2 = moderate stenosis (50-74%), 3 = severe stenosis (75-99%), and 4 = occlusion. All 67 patients were alive at 3-year, and the 32 transplanted patients successfully engrafted. No stroke or recurrence occurred during the follow-up. No chronic-GVHD was observed. Among the 7 patients with stroke-history, all had stenosis at enrollment and the stenosis score increased in the 4 transplanted patients, but always in the arteries with previous stenosis and those feeding ischemic territories, while stenosis score remained mostly stable in the 3 patients maintained on chronic transfusion,. However, the difference between treatment groups was not significant (p=0.057). Among the 60 stroke-free patients at enrollment, 28 with MSD were transplanted while 32 without MSD were maintained on chronic transfusion. At enrollment, 28 patients (14 patients in each treatment group) had stenosis. At 1-year, 9 patients in the SCT group had stenosis, whereas in the transfusion/standard-care group, 10 had stenosis. At 3-year, 5 patients in the SCT group had stenosis, while 10 still had stenosis in the standard-care group. Moreover, 2 patients, who had no stenosis at enrollment, developed one stenosis between 1 and 3-year, despite chronic transfusion in one case and after switch to hydroxyurea in the other. In another patient, stenosis had disappeared on chronic transfusion at 1-year, although it reappeared at 3-year after a switch to hydroxyurea. In the SCT group, no worsening of stenosis was observed, and stenosis improved in 13/14 and was stable in one; in contrast, worsening of stenosis score was observed in the standard-care group in 6 patients on chronic transfusion (p=0.035), The stenosis-score between enrollment and 3-year improved more significantly in the SCT group (mean (SD): -1.39 (2.47)) than in the standard care group (-0.06 (1.18)); (p=0.012). Conclusions: This prospective trial reporting the outcome of stenosis in stroke and stroke-free SCA-patients with a history of abnormal-TCD shows a trend to worsening of the stenosis-score after SCT in stroke-patients, but no stroke recurrence; in contrast, in stroke-free patients, stenosis outcome was significantly better after SCT and with better prevention of stenosis occurrence than on standard care. These results support early recommendation of SCT in children with a history of abnormal-TCD and an MSD. Figure Disclosures Verlhac: Addmedica, Paris: Other: Financial Support; Bluebird Bio: Consultancy. Brousse:bluebird bio: Consultancy; Add medica: Consultancy. De Montalembert:Addmedica: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Bluebird Bio: Membership on an entity's Board of Directors or advisory committees. Thuret:BlueBird bio: Other: investigators for clinical trials, participation on scientific/medical advisory board; Celgene: Other: investigators for clinical trials, participation on scientific/medical advisory board; Novartis: Other: investigators for clinical trials, participation on scientific/medical advisory board; Apopharma: Consultancy. Bernaudin:GBT: Membership on an entity's Board of Directors or advisory committees; AddMedica: Honoraria, Other: Help for travel to meeting; BlueBirdBio: Consultancy.

Early treatment of acute migraine: New evidence of benefits

Cephalalgia ◽  
2009 ◽  
Vol 29 (3_suppl) ◽  
pp. 15-21
Author(s):  
D Valade
Keyword(s):  
Perceived Barriers ◽  
Management Approach ◽  
Migraine Treatment ◽  
Positive Outcomes ◽  
Barriers To Adoption ◽  
Current Management ◽  
Migraine Headaches ◽  
Therapeutic Outcomes ◽  
Lower Pain ◽  
New Evidence

The current management approach to migraine headaches advocates use of triptan medications early in the course of an attack while pain is still mild, rather than waiting to treat the pain when it has progressed to moderate-severe. Recently, strong new evidence for the benefits of early intervention has become available. The AEGIS, AIMS and AwM studies of almotriptan in patients with migraine indicate that earlier treatment initiation and lower pain intensity at the time of treatment are important predictors of enhanced therapeutic outcomes. The opportunity to treat early exists for about 50% of all migraine attacks, which offers considerable scope for improving migraine management. Importantly, treating pain early and before it has progressed beyond ‘mild’ meets many of the expectations patients have of their migraine treatment. It is believed that consistent, positive outcomes may assist in overcoming the various physician-and patient-perceived barriers to adoption of this beneficial treatment strategy.

A Phase 1/2A Open-Label Study of Pralatrexate and Gemcitabine in Patients with Relapsed or Refractory Lymphoproliferative Malignancies.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1570-1570 ◽  
Author(s):  
Steven M. Horwitz ◽  
Julie M. Vose ◽  
Ranjana Advani ◽  
Kamalesh Sankhala ◽  
Swaminathan Padmanabhan ◽  
...  
Keyword(s):  
Treatment Group ◽  
B Cell ◽  
Cell Lymphoma ◽  
Phase 1 ◽  
Hodgkin's Lymphoma ◽  
Open Label ◽  
Dosing Schedule ◽  
Treatment Groups ◽  
Heavily Pretreated ◽  
Group A

Abstract Background: Pralatrexate (PDX) is a novel targeted antifolate that is designed to accumulate preferentially in cancer cells. Pralatrexate has demonstrated activity in the treatment of non-Hodgkin’s lymphoma (NHL). Single-agent gemcitabine (Gem) has demonstrated promising activity in relapsed Hodgkin’s lymphoma, T-cell lymphoma, and select sub-types of B-cell NHL. Based on pre-clinical data demonstrating a schedule dependent synergy for this combination (pralatrexate + Gem) (Clin Cancer Res2006; 12(3):924–932), a Phase 1/2a, non-randomized, open-label, multi-center trial was designed to assess the potential co-administration of these 2 agents. The primary objective of the study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose when pralatrexate and Gem are administered with vitamin B12 and folic acid supplementation to patients (pts) with relapsed/refractory lymphoma. Methods: Initially, pts were assigned to a schedule of pralatrexate, followed the next day by Gem, once weekly for 3 of 4 weeks (Treatment group A). When this schedule was poorly tolerated, new cohorts were enrolled in a dose escalating fashion: Treatment group B – pralatrexate (10 mg/m2) followed the next day by Gem (300–400 mg/m2) once every 2 weeks (q 2 weeks); and Treatment group C – pralatrexate (10 mg/m2) followed 1 hour later by Gem (300–400 mg/m2) q 2 weeks. Eligibility criteria include histologically confirmed lymphoma, documented disease progression (PD) after 3 1 prior treatment, and ECOG PS £ 2. Results: As of August 2008, 20 pts have been treated on this study, including 11 males (55%) and 9 females (45%). Pt histology is as follows: 8 pts [40%] diffuse large B-cell lymphoma [DLBCL]; 1 pt [5%] follicular lymphoma, Hodgkin lymphoma (HL) (5 pts [26%]), T/NK-cell (5 pts [26%]), and composite DLBCL and PTCL (1 pt [5%]). Pts were heavily pre-treated having received a median of 4 prior regimens (range 3–12) with a median of 3 prior systemic regimens (range 2–10). Treatment group A was not well tolerated as evidenced by the incidence of Grade (Gr) 3–4 hematological toxicities. In comparison pts in treatment groups B and C had far fewer adverse events (AEs) with lower severity toxicities. Across all dose cohorts and treatment groups, the most frequently reported Gr 3–4 AEs considered to be treatment related have been neutropenia (9 pts [45%]) thrombocytopenia (9 pts [45%]), and anemia (8 pts [40%]). Preliminary efficacy data show 6 pts (30%) with partial response (PR): 4 with HL, 1 with DLBCL, and 1 with composite DLBCL and PTCL. PRs occurred on both the sequential dosing schedule (5 pts) and the same-day dosing schedule (1 pt). The HL pts with a PR were heavily pretreated (7, 8, 11, and 12 prior therapies) and all had received previous Gem, 3 of the 4 without response. Conclusion: The combination of pralatrexate and Gem can be safely administered on a q 2 week schedule. The MTD was established for the sequential day schedule as pralatrexate 10/Gem 300 (mg/m2). Dose escalation continues on the same day schedule. Pralatrexate and Gem administration at a frequency of 3/4 weeks is not feasible in heavily pretreated pts due to hematologic toxicity; however, when administered on a 2 q week schedule, the combination has shown a favorable safety profile. The combination of pralatrexate and Gem has shown encouraging activity in pts with heavily pre-treated, refractory lymphomas and enrollment in the study is ongoing to define the MTD on a same day schedule. Cohort Number of Pts Dose Pralatrexate/Gem (mg/m2) Schedule #DLTs DLT (Grade) A1 2 15/400 Sequential days, 3/4 weeks 2 Thrombocytopenia (Gr 4); Neutropenia (Gr 3) & Thrombocytopenia (Gr 3) A-1 2 10/400 Sequential days, 3/4 weeks 2 Neutropenia (Gr 3) Thrombocytopenia Gr 3) A-2 3 10/300 Sequential days, 3/4 weeks 2 Thrombocytopenia (Gr 3) Neutropenia (Gr 3) B1 3 10/300 Sequential days, q 2 weeks 0 B2 3 10/400 Sequential days, q 2 weeks 0 B3 2 15/400 Sequential days, q 2 weeks 2 Cellulitis (Gr 3) Pulmonary embolus (Gr 3) C1 3 10/300 Same day, q 2 weeks 0 C2 2 10/400 Same day, q 2 weeks 1 Hypoxia (Gr 3) &

scholarly journals Suicidal behaviour in psychosis: Prevalence and predictors from a randomised controlled trial of case management

2001 ◽  
Vol 178 (3) ◽  
pp. 255-260 ◽  
Author(s):  
Elizabeth Walsh ◽  
Kate Harvey ◽  
Ian White ◽  
Anna Higgitt ◽  
Janelle Fraser ◽  
...  
Keyword(s):  
Case Management ◽  
Suicidal Behaviour ◽  
Standard Care ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Intensive Case Management ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Chronic Psychosis

BackgroundIt is unclear whether intensive case management influences the prevalence of suicidal behaviour in patients with psychosis.AimsTo compare the effect of intensive case management and standard care on prevalence of suicidal behaviour in patients with chronic psychosis.MethodPatients with established psychosis (n=708) were randomised either to intensive case management or to standard care. The prevalence of suicidal behaviour was estimated at 2-year follow-up and compared between treatment groups. Suicide attempters and non-attempters were compared on multiple socio-demographic and clinical variables to identify predictors of suicidal behaviour.ResultsThere was no significant difference in prevalence of suicidal behaviour between treatment groups. Recent attempts at suicide and multiple recent hospital admissions best predicted future attempts.ConclusionsIntensive case management does not appear to influence the prevalence of suicidal behaviour in chronic psychosis. Predictors identified in this study confirm some previous findings.

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