scholarly journals Lisinopril as a prophylactic agent for migraine: a randomised double blind placebo controlled cross over prospective study in Kashmir

2021 ◽  
Vol 8 (4) ◽  
pp. 536
Author(s):  
Irfan Yousuf Wani ◽  
Sheikh Saleem ◽  
Iqra Mehraj
Keyword(s):  
Prospective Study ◽  
Treatment Period ◽  
Severity Index ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Prophylactic Agent ◽  
Headache Severity ◽  
Prophylactic Drug ◽  
Normotensive Subjects

Background: Migraine is one of the commonest neurological disorder seen by neurologists. Many different medications are available to be used as prophylactic agent. We conducted this study to determine the efficacy of Lisinopril as a prophylactic drug for migraine in our region.Methods: Our study is a randomised double blind, placebo controlled, cross over, prospective study. 60 patients were included in this study. Treatment period of 12 weeks with one 10 mg lisinopril tablet once daily for one week then two 10 mg lisinopril tablets once daily for 11 weeks, followed by a two week wash out period. Second treatment period of one placebo tablet once daily for one week and then two placebo tablets for 11 weeks. Thirty participants followed this schedule, and 30 received placebo followed by lisinopril. Primary end points were number of hours with headache, number of days with headache, number of days with migraine.Results: Statistical analysis of data from 41 patients that completed this study revealed that hours with headache, days with headache, days with migraine, and headache severity index were significantly reduced by 16%, 16% , 23% and 17% , respectively, with lisinopril as compared to placebo.Conclusions: This study favours lisinopril as an effective prophylactic drug for migraine. The adverse effects of lisinopril, though of significant frequency, have been mild to moderate in severity but were well tolerated by even normotensive subjects.

Comparison of Propranolol LA 80 mg and Propranolol LA 160 mg in Migraine Prophylaxis: A Placebo Controlled Study

Cephalalgia ◽  
1993 ◽  
Vol 13 (2) ◽  
pp. 128-131 ◽  
Author(s):  
Hisham K Al-Qassab ◽  
Leslie J Findley
Keyword(s):  
Side Effects ◽  
Migraine Prophylaxis ◽  
Controlled Study ◽  
Headache Frequency ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Headache Severity ◽  
Negative Effect ◽  
Long Acting

Thirty patients with severe classical and common migraine participated in a double-blind placebo-con-trolled cross-over study of migraine prophylaxis with propranolol LA (long-acting) 80 mg once daily, or propranolol LA 160 mg once daily or placebo. Each treatment was given for two months. There were no significant differences between the three treatment periods in headache frequency, headache severity, nausea frequency or severity. There was a non-significant trend for reduced duration of headache with the two doses of propranolol. The possible reasons for this negative effect are discussed. The safety of propranolol and its lack of serious side effects were demonstrated.

Simethicone in the Treatment of Infant Colic: A Randomized, Placebo-Controlled, Multicenter Trial

PEDIATRICS ◽  
1994 ◽  
Vol 94 (1) ◽  
pp. 29-34
Author(s):  
Thomas J. Metcalf ◽  
Thomas G. Irons ◽  
Lawrence D. Sher ◽  
Paul C. Young
Keyword(s):  
Treatment Period ◽  
Multicenter Trial ◽  
Crossover Fashion ◽  
Infantile Colic ◽  
Parental Report ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Infant Colic ◽  
Geographic Regions

Objective. To determine the efficacy of simethicone in the treatment of infant colic. Design. Randomized, double blind, placebo-controlled. Setting. Three general pediatric practices in distinct geographic regions. Patients. Eighty-three infants between 2 and 8 weeks of age with infant colic. Interventions. Treatment with simethicone and placebo in double blind crossover fashion. Results. A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group. Conclusion. Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.

scholarly journals Efficacy of tofacitinib in reduction of inflammation detected on MRI in patients with Psoriatic ArthritiS presenTing with axial involvement (PASTOR): protocol of a randomised, double-blind, placebo-controlled, multicentre trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e048647
Author(s):  
Fabian Proft ◽  
Murat Torgutalp ◽  
Burkhard Muche ◽  
Valeria Rios Rodriguez ◽  
Maryna Verba ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Treatment Period ◽  
Group Treatment ◽  
Activity Index ◽  
Treatment Options ◽  
Study Endpoint ◽  
Primary Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Axial Involvement

IntroductionPsoriatic arthritis (PsA) is an inflammatory disease characterised by synovitis, enthesitis, dactylitis and axial involvement. The prevalence of axial involvement ranges from 25% to 70% in this patient group. Treatment recommendations for axial PsA were mainly extrapolated from guidelines for axial spondyloarthritis, and the main treatment options are non-steroidal anti-inflammatory drugs and biological disease-modifying antirheumatic drugs (tumour necrosis factor, IL-17 and IL-23 inhibitors). Tofacitinib was approved for the treatment of PsA and its efficacy on axial inflammation has been demonstrated in a phase II study of ankylosing spondylitis (AS). This prospective study aims to evaluate the efficacy of tofacitinib in reducing inflammation in the sacroiliac joints (SIJs) and spine on MRI in patients with axial disease of their PsA presenting with active axial involvement compatible with axial PsA.Methods and analysesThis is a randomised, double-blind, placebo-controlled, multicentre clinical trial in patients with axial PsA who have evidence of axial involvement, active disease as defined by a Bath AS Disease Activity Index score of ≥4 and active inflammation on MRI of the SIJs and/or spine as assessed by and independent central reader. The study includes a 6-week screening period, a 24-week treatment period, which consist of a 12-week placebo-controlled double-blind treatment period followed by a 12-week active treatment period with tofacitinib for all participants, and a safety follow-up period of 4 weeks. At baseline, 80 subjects shall be randomised (1:1) to receive either tofacitinib or matching placebo for a 12-week double-blind treatment period. At week 12, an MRI of the whole spine and SIJs will be performed to evaluate the primary study endpoint.Ethics and disseminationThe study will be performed according to the ethical principles of the Declaration of Helsinki and the German drug law. The independent ethics committees of each centre approved the ethical, scientific and medical appropriateness of the study before it was conducted.Trial registration numberNCT04062695; ClinicalTrials.gov and EudraCT No: 2018-004254-22; European Union Clinical Trials Register.

scholarly journals OR11-03 NT-814, a Non-Hormonal Dual Neurokinin 1,3 Receptor Antagonist Markedly Improves Vasomotor Symptoms in Post-Menopausal Women; Results of a Randomised, Double-Blind, Placebo-Controlled, Dose-Finding Study (SWITCH-1)

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
James Simon ◽  
Richard A Anderson ◽  
Elizabeth Ballantyne ◽  
Hadine Joffe ◽  
Mary Kerr ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Dose Finding ◽  
Vasomotor Symptoms ◽  
Phase 3 ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Vasomotor symptoms (VMS), caused by declining estrogen in menopausal women, are common and debilitating. Hormone therapy is effective in many women but carries risks and may be contraindicated. Biological and clinical evidence shows a modulatory role for neurokinin (NK) receptor antagonists acting primarily via hypothalamic KNDy (kisspeptin, NK, dynorphin) neurons on VMS. NT-814 is an oral non-hormonal dual NK1,3 receptor antagonist which has previously been shown to cause rapid and marked improvements in VMS in post-menopausal women. This Phase-2b trial (SWITCH-1) was undertaken to further evaluate efficacy and safety and to establish the optimum dose(s) for Phase 3 studies. Methods: SWITCH-1 was a double-blind, placebo-controlled, adaptive-randomization, dose-finding trial in 199 post-menopausal women. After a 2-week single-blind placebo run-in to establish symptom stability, women (40 to 65 years) with ≥7 moderate and/or severe VMS per day at baseline were randomized to 12 weeks of once daily treatment with placebo or one of 4 doses of NT-814: 40 mg, 80 mg, 120 mg, 160 mg. Subjects recorded the frequency and severity of VMS in electronic diaries twice daily throughout the study. Patient-reported measures of quality-of-life, sleep and mood were collected periodically. Adverse events (AEs) were recorded at each clinic visit. Results: VMS frequency was reduced in all treatment groups, including placebo. VMS reductions were significantly greater with the 2 higher NT-814 doses at most time-points, as early as the first week of treatment. Least squares mean reductions from baseline in moderate/severe VMS per day at week 4 were: placebo, 2.7; 40 mg, 4.3 (p=0.161 vs placebo); 80 mg, 4.1 (p=0.326); 120 mg, 6.7 (p<0.0001); 160 mg, 5.5 (p=0.007). In week 12 the reductions were: placebo, 4.7; 40 mg, 6.5 (p=0.185); 80 mg, 5.6 (p=0.599); 120 mg, 7.8 (p=0.009); 160 mg, 6.6 (p=0.109). At the 160 mg dose the median reduction in week 12 was significantly greater than placebo (6.9 vs 4.4, p=0.0023), indicating an effect of high outliers on the mean. Average HF severity was also improved in a dose-related manner, with greater reductions compared to placebo with the 2 higher NT-814 doses. Improvements in HF were accompanied by statistically significant benefits on sleep (assessed using the Insomnia Severity Index and Pittsburgh Sleep Quality Index), mood (measured using the Beck Depression Inventory), and all four domains of the MenQoL menopause-specific quality-of-life instrument. NT-814 was well-tolerated; most AEs were mild or moderate and there were no serious AEs related to treatment. Conclusions: NT-814, a once daily non-hormonal NK antagonist, at doses of 120 & 160 mg reduced the frequency and severity of VMS and significantly improved quality of life, mood and sleep, in postmenopausal women. NT-814 was well tolerated, with a safety profile that supports further evaluation in Phase 3 trials.

Toreforant, A Histamine H4 Receptor Antagonist, in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Results of 2 Phase II Studies

2016 ◽  
Vol 43 (9) ◽  
pp. 1637-1642 ◽  
Author(s):  
Robin L. Thurmond ◽  
Andrew Greenspan ◽  
Waldemar Radziszewski ◽  
Xie L. Xu ◽  
Ye Miao ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Receptor Antagonist ◽  
Active Rheumatoid Arthritis ◽  
Dose Range ◽  
Joint Disease ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Range Finding ◽  
Phase Ii Studies

Objective.To assess toreforant (selective histamine H4 receptor antagonist) in active rheumatoid arthritis (RA).Methods.In a phase IIa, double-blind, placebo-controlled test, 86 patients were randomized (2:1) to once-daily toreforant 100 mg or placebo for 12 weeks. In phase IIb, double-blind, placebo-controlled, dose-range–finding evaluations, 272 patients were randomized (1:1:1:1) to once-daily placebo or toreforant 3/10/30 mg. Primary efficacy endpoints for both studies were Week 12 changes in 28-joint Disease Activity Score–C-reactive protein (DAS28-CRP).Results.Phase IIa testing was terminated prematurely (patient fatality; secondary hemophagocytic lymphohistiocytosis). Posthoc analyses indicated toreforant 100 mg/day reduced RA signs/symptoms through Week 12. Phase IIb testing, however, showed no significant Week 12 improvement in DAS28-CRP with toreforant.Conclusion.Toreforant was not effective in phase IIb testing.

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