scholarly journals Cognitive Effects of Montelukast: A Pharmaco-EEG Study

2021 ◽  
Vol 11 (5) ◽  
pp. 547
Author(s):  
Fabian Schwimmbeck ◽  
Wolfgang Staffen ◽  
Christopher Höhn ◽  
Fabio Rossini ◽  
Nora Renz ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Small Sample Size ◽  
Brain Activity ◽  
Term Treatment ◽  
Small Sample ◽  
Double Blind Study ◽  
Double Blind ◽  
Cognitive Improvement ◽  
Gamma Power ◽  
Cognitive Benefits

Montelukast is a well-established antiasthmatic drug with little side effects. It is a leukotriene receptor antagonist and recent research suggests cognitive benefits from its anti-inflammatory actions on the central nervous system. However, changes in brain activity were not directly shown so far in humans. This study aims to document changes in brain activity that are associated with cognitive improvement during treatment with Montelukast. We recorded EEG and conducted neuropsychological tests in 12 asthma-patients aged 38–73 years before and after 8 weeks of treatment with Montelukast. We found no significant changes on neuropsychological scales for memory, attention, and mood. In the EEG, we found decreased entropy at follow up during rest (p < 0.005). During episodic memory acquisition we found decreased entropy (p < 0.01) and acceleration of the background rhythm (p < 0.05). During visual attention performance, we detected an increase in gamma power (p < 0.005) and slowing of the background rhythm (p < 0.05). The study is limited by its small sample size, young age and absence of baseline cognitive impairment of the participants. Unspecific changes in brain activity were not accompanied by cognitive improvement. Future studies should examine elderly patients with cognitive impairment in a double-blind study with longer-term treatment by Montelukast.

A randomized, double-blind study comparing corticorelin acetate with dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptoms of peritumoral brain edema

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2080-2080 ◽  
Author(s):  
W. R. Shapiro ◽  
L. Mechtler ◽  
L. Cher ◽  
H. Wheeler ◽  
V. Hines ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Study Drug ◽  
Similar Efficacy ◽  
Small Sample ◽  
Double Blind Study ◽  
Karnofsky Performance Score ◽  
Double Blind ◽  
Treatment Groups ◽  
Cerebral Tumors ◽  
Peritumoral Brain Edema

2080 Background: Corticorelin acetate (CrA) is a synthetic peptide of corticotropin-releasing factor, undergoing clinical trials as a treatment for peritumoral edema in patients with cerebral tumors. This study compared CrA therapy vs an increase in dexamethasone (dex) dose (+4 mg) for controlling symptoms in primary glioma patients with a subacute exacerbation. Methods: In addition to their prestudy dex dose, patients were randomized to receive CrA 1 mg bid SC or control (+4 mg dex PO) for 8 weeks. Patients were evaluated at baseline and during weeks 1 and 2 for their neurologic status, Karnofsky Performance Score (KPS), and continuing dex requirements. The primary endpoint was response, defined as no post-baseline increase in dex dose >4 mg for >1 day; stable or improved KPS; and ≥25% improvement in 10-item Neurological Examination Score during weeks 1 and 2. Dex therapy requirements were also evaluated. The study aimed to enroll 120 patients, but was terminated with only 37 patients (20 CrA, 17 control) due to slow recruitment. Results: Formal statistical analyses were not undertaken due to the small sample size. The treatment groups had similar demographic and baseline disease characteristics. Despite the small numbers, the data suggest that CrA treatment had similar efficacy to increased dex: (1) The proportions of responders were similar (CrA 3/20; control 3/17); (2) Comparable proportions of patients completed 8 weeks’ treatment (CrA 16/20; control 12/17); (3) After randomization of blinded study drug (CrA or dex 4 mg), dex dosing remained stable for most patients in each arm (CrA 12/20; control 11/17); (4) The mean daily dex dose was 3 mg in the CrA arm and 7 mg in the control arm. There was a lower incidence of cushingoid symptoms in the CrA arm (CrA 1/20, control 3/17). Patients in the CrA arm reported more injection site erythema and flushing vs. the control arm. CrA was well tolerated and no patient withdrew from the trial because of CrA side effects. Conclusions: CrA may be of value in managing patients with cerebral tumors who have subacute exacerbations of their symptoms, without needing to increase their dex dose. [Table: see text]

A phase II study of ribociclib in men with unresectable, incurable teratoma with recent progression.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 517-517 ◽  
Author(s):  
Daniel E. Castellano ◽  
David I. Quinn ◽  
Darren R. Feldman ◽  
Karim Fizazi ◽  
Xavier Garcia del Muro ◽  
...  
Keyword(s):  
Chest Pain ◽  
Small Sample Size ◽  
Progression Free Survival ◽  
Functional Expression ◽  
Small Sample ◽  
Clinical Activity ◽  
Double Blind Study ◽  
Double Blind ◽  
Standard Medical Therapy ◽  
Best Response

517 Background: Most patients with teratoma are managed by surgery and no standard medical therapy exists for progressive and/or unresectable teratoma. Teratomas have functional expression of retinoblastoma protein and clinical activity was observed with CDK4/6 inhibition (Vaughn DJ, et al. Cancer. 2015). Here, we report results with the CDK4/6 inhibitor ribociclib (RIBO) for unresectable teratoma. Methods: This multicenter, double-blind study enrolled patients (pts) ≥ 15 years old with unresectable, progressive teratoma without malignant transformation, ECOG PS 0-1, and ≥ 1 line of prior chemotherapy. Pts were randomized (2:1) to receive RIBO (600 mg/day, 3 weeks on/1 week off) or placebo (PBO). Crossover to RIBO was permitted following progressive disease (PD) on PBO. The primary endpoint was progression-free survival (PFS). Secondary endpoints included additional efficacy measures, safety, and tolerability. Results: The trial was closed prematurely in the setting of slow accrual. Ten pts were randomized (8 to RIBO, 2 to PBO). Median age was 33 years (range, 21-53). All pts received study treatment, and both pts in the PBO arm crossed over to RIBO following PD. Median exposure was 385 days for RIBO and 166 days for PBO. The PFS rates at 24 months were 71% and 0% in the RIBO and PBO arms, respectively. All 8 pts in the RIBO arm had stable disease (SD) as best response at first evaluation. In the PBO arm, 1 pt had best response of PD and the other SD with durations of treatment of 78 and 254 days, respectively. After crossover, both pts received RIBO, with a best response of SD, and durations of treatment of 943 and 133 days, respectively; the former entered a rollover protocol and the latter discontinued treatment due to an adverse event. The most common reason for discontinuation in both groups was PD. Grade ≥ 3 adverse events in the RIBO group included neutropenia and non-cardiac chest pain in 2 pts, and headache, decreased appetite, asthenia, fatigue, vomiting, and increased blood creatinine in 1 pt each; all but non-cardiac chest pain were suspected to be drug related. Conclusions: In this rare clinical setting, with a limited small sample size, RIBO prolonged PFS as compared to PBO and no new safety signals emerged. Clinical trial information: NCT02300987.

scholarly journals Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study)

2014 ◽  
Vol 72 (6) ◽  
pp. 411-417 ◽  
Author(s):  
Paulo Caramelli ◽  
Jerson Laks ◽  
André Luis Fernandes Palmini ◽  
Ricardo Nitrini ◽  
Márcia Lorena Fagundes Chaves ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sex Education ◽  
Small Sample Size ◽  
Drug Dose ◽  
Small Sample ◽  
Mixed Dementia ◽  
Double Blind ◽  
Cognitive Benefits ◽  
Cognitive Speed

The effects of galantamine (GAL) on quality of life (QoL) and cognitive speed, as well its effects combined with nimodipine (NIM) in Alzheimer disease (AD) with cerebrovascular disease (mixed dementia), have not been explored. Method : Double-blind, placebo-controlled, multicenter Brazilian trial, studying the effects of GAL/NIM vs. GAL/placebo (PLA) in mild to moderate mixed dementia. Patients were randomized to receive GAL/NIM or GAL/PLA for 24 weeks. Primary efficacy measures were changes on a computerized neuropsychological battery (CNTB) and QoL Scale in Alzheimer's Disease (QoL-AD) from baseline to week 24. Results : Twenty-one patients received at least one drug dose (9 GAL/NIM and 12 GAL/PLA). Groups were matched for age, sex, education, cognitive and QoL scores at baseline. No significant differences were observed between groups on primary or secondary measures. QoL and cognitive performance showed significant improvement (p<0.05) from baseline when all GAL-treated patients were analyzed. Adverse events were predominantly mild to moderate. Conclusion : GAL treatment improved QoL in mixed dementia, in addition to its previously known cognitive benefits. The combination GAL/NIM was not advantageous. However, the small sample size precludes any definitive conclusions. Trial registered at ClinicalTrials.gov: NCT00814658

A Multicenter, Randomized, Double-Blind Study Comparing a Daily Bedtime Administration of Famotidine and Ranitidine in Short-Term Treatment of Active Duodenal Ulcer

Digestion ◽  
1989 ◽  
Vol 42 (2) ◽  
pp. 79-85 ◽  
Author(s):  
R. Alcalá-Santaella ◽  
J. Guardia ◽  
J. Pajares ◽  
J. Piqué ◽  
L. Pita ◽  
...  
Keyword(s):  
Duodenal Ulcer ◽  
Term Treatment ◽  
Blind Study ◽  
Double Blind Study ◽  
Short Term ◽  
Short Term Treatment ◽  
Double Blind

Comparative Efficacy of Once Daily Loratadine versus Terfenadine in the Treatment of Allergic Rhinitis

1989 ◽  
Vol 17 (2) ◽  
pp. 150-156 ◽  
Author(s):  
C. H. Banov
Keyword(s):  
Allergic Rhinitis ◽  
Initial Dose ◽  
Small Sample Size ◽  
Small Sample ◽  
Double Blind ◽  
Once Daily ◽  
Excellent Response ◽  
Parallel Group ◽  
Parallel Group Trial ◽  
Group Trial

This 1 week study compared the efficacy of once daily administration of 10 mg loratadine with 120 mg terfenadine in out-patients with seasonal allergic rhinitis. It focussed on the efficacy of treatment at the end of the 24 h period following a daily dose. The study was designed as a double-blind, randomized, parallel-group trial, and 41 patients were enrolled and evaluated for efficacy. Patients took an initial dose at the study site and returned on days 2 and 8. At day 2 (24 h after the initial dose), according to the physician's evaluation 57% of loratadine-treated patients had a good or excellent response, compared to 50% of those given terfenadine. At day 8, 24 h after the final dose, 71% of the loratadine-treated patients and 35% of the terfenadine-treated patients had a good or excellent response ( P = 0.03). At days 2 and 8, reductions in mean symptom scores measured 22, 23 and 24 h after the initial and final doses showed an indication of being greater with loratadine than with terfenadine (non-significant due to small sample size). The incidence of sedation was similar in both groups. It is concluded that 10 mg loratadine, administered once daily, controls the symptoms of rhinitis more effectively than 120 mg terfenadine given once daily in the last few hours of the 24 h dosing period.

scholarly journals Review of the Studies in the Use of Biofeedback Therapy in Rehabilitation and Physiatrics of Neurological Patients

Doctor Ru ◽  
2021 ◽  
Vol 20 (9) ◽  
pp. 43-47
Author(s):  
E.Yu. Mozheyko ◽  
◽  
O.V. Petryaeva ◽  
◽  
◽  
...  
Keyword(s):  
Large Scale ◽  
Small Sample Size ◽  
Small Sample ◽  
Healthy Population ◽  
Biofeedback Therapy ◽  
Level Of Evidence ◽  
Double Blind ◽  
Key Points ◽  
Neurological Patients ◽  
Drug Free

Objective of the Review: To collect information, analyse and evaluate previous studies in the use of biofeedback in neurological patients. Key Points. Despite the wide practical application and a lot of available publications, the level of evidence of this method is low because of a small sample size and the challenges with biofeedback mechanism description. A review of various types of biocontrol, its mechanisms and developments shows that drug-free therapy using only patient’s resources (organic, psychological, emotional and volitional) can activate the mechanisms of neuroplasticity, which are poorly studied. Still, it does not prevent from using biocontrol for the therapy of patients and/or prevention of various diseases in healthy population. Conclusion. Biofeedback therapy has proven to be a safe, relatively efficient and easy-to-use method. However, organisation of a large-scale double blind randomized trial is one of the predominant directions in the future. Keywords: biofeedback, biocontrol, neurofeedback, biofeedback therapy.

scholarly journals Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19)

2021 ◽  
Author(s):  
Marvin R. McCreary ◽  
Patrick M. Schnell ◽  
Dale A. Rhoda
Keyword(s):  
Pulmonary Embolism ◽  
Adverse Events ◽  
Small Sample Size ◽  
Primary Outcome Measure ◽  
Small Sample ◽  
Double Blind ◽  
Phase 2 Study ◽  
Clinically Significant ◽  
Low Incidence ◽  
To Receive

Abstract Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol. Both groups received a single dose of Vitamin D3 which was used as an adjunct. The primary outcome measure was hospitalization within 21 days of symptom onset; secondary measures were ER visits, incidence of pneumonia and pulmonary embolism. Five patients chose not to participate after randomization. Twenty-one day outcome was determined of all one hundred participants (mean [SD] age 55.6 [8.8] years; 61% female) (or their surrogates). There were no clinically significant adverse events attributed to resveratrol. Outpatients in this phase 2 study treated with resveratrol had a lower incidence compared to placebo of: hospitalization (2% vs. 6%, RR 0.33, 95% CI 0.04-3.10), COVID-related ER visits (8% vs. 14%, RR 0.57, 95% CI 0.18-1.83), and pneumonia (8% vs. 16%, RR 0.5, 95% CI 0.16-1.55). One patient (2%) in each group developed pulmonary embolism (RR 1.00, 95% CI: 0.06-15.55). This underpowered study was limited by small sample size and low incidence of primary adverse events. A larger trial could determine efficacy.TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04400890 26/05/2020; FDA IND #150033 05/05/2020

Effect of coadministration of propranolol and etodolac (VT-122) plus sorafenib for patients with advanced hepatocellular carcinoma (HCC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 390-390 ◽  
Author(s):  
Andrew N de la Torre ◽  
Ismael Castaneda ◽  
Aram F. Hezel ◽  
Newell F. Bascomb ◽  
Gouri Shankar Bhattacharyya ◽  
...  
Keyword(s):  
Hepatitis Virus ◽  
Small Sample Size ◽  
Small Sample ◽  
Controlled Study ◽  
Advanced Hepatocellular Carcinoma ◽  
Separate Study ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Duration Of Therapy ◽  
Significant Efficacy

390 Background: Propranolol and etodolac (designated VT-122) target the adrenergic and prostaglandin stress systems activated in HCC. These stress-induced systems are proposed to induce changes in the tumor microenvironment and immune system leading to tumor promotion and immune tolerance. In a separate study, administration of VT-122 prior to sorafenib showed an increase in median overall survival (OS) of 21 months when VT-122 is administered before sorafenib compared to 10 months OS for sorafenib alone. The aim of the current study was to evaluate the effect of administering VT-122 at least 30 days after starting sorafenib. Methods: Patients with HCC receiving sorafenib for at least 30 days were eligible for this double-blind, placebo-controlled study. Patients were randomized to receive sorafenib with either VT-122 or placebo. Patients received therapy for up to 12 months or until treatment failure. VT-122 was administered twice daily. The primary endpoint was duration of therapy (DoT) and the secondary endpoint was OS. Results: Twenty patients were randomized, 11 and 9 patients to the VT122 and placebo arm, respectively. Each arm was balanced with regards to age (mean of 60.4 years), Child Pugh status (9 Child Pugh A, 11 Child Pugh B7), hepatitis virus status (6 HBV and 1 HCV positive) and C-reactive protein (CRP) (20.4 mg/L). VT122 with sorafenib was well tolerated with no unexpected serious adverse events reported. Mean OS was 13.9 months and 9.6 months in the VT-122 and placebo arms, respectively. Mean DoT (unvalidated) was 10.1 months and 7.5 months in the VT-122 and placebo arms, respectively. Conclusions: Co-administration of VT-122 with sorafenib was well tolerated and showed an increase in duration of therapy and OS versus sorafenib alone. The small sample size and number of events precludes the ability to make any significant efficacy conclusions. The increase in survival was not as great as that seen in a separate study in which VT122 was started prior to sorafenib. A further Phase 3 study of VT122 administered prior to sorafenib in patients with HCC is warranted. Clinical trial information: NCT01265576.

HAGIL (Hamburg Vigil Study): a randomized placebo-controlled double-blind study with modafinil for treatment of fatigue in patients with multiple sclerosis

2011 ◽  
Vol 17 (8) ◽  
pp. 1002-1009 ◽  
Author(s):  
F Möller ◽  
J Poettgen ◽  
F Broemel ◽  
A Neuhaus ◽  
M Daumer ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Impairment ◽  
Safety Concern ◽  
Dropout Rate ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Neuropsychological Measures ◽  
Intention To Treat

Objective: To reassess the effect of modafinil, a wakefulness-promoting artificial psychostimulant, on fatigue and neuropsychological measures in patients with multiple sclerosis. Methods: Multiple sclerosis (MS) patients with a baseline score of ≥4 on the Fatigue Severity Scale (FSS) and an Expanded Disability Status Scale score <7 were eligible for the 8-week randomized, double-blind, placebo-controlled study. Modafinil was dosed up to 200 mg/day within 1 week. Assessments were performed at baseline and after 4 and 8 weeks. The primary outcome parameter was the mean change of the FSS mean score. Secondary outcome variables were other questionnaires covering fatigue, daytime sleepiness and sleep quality. Cognitive impairment was assessed by the oral version of the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT). Results: The study included 121 MS patients. Dropout rate was 9%. Both treatment groups showed improvements through time. While mean FSS at 8 weeks showed a trend difference between groups in the intention-to-treat analysis, the primary endpoint was not met. Assessment of cognitive impairment by SDMT and PASAT showed contradictory results. All other secondary endpoints were not met. There was no major safety concern. Conclusions: In general, the study does not support modafinil as an effective treatment for MS fatigue. However, the study shows the need for new study designs and endpoints in MS fatigue studies.

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