scholarly journals P.034 Eptinezumab Demonstrated Early Relief from Episodic and Chronic Migraine: Consistency of Effect Across 4 Clinical Trials

2021 ◽  
Vol 48 (s3) ◽  
pp. S30-S30
Author(s):  
DW Dodick
Keyword(s):  
Clinical Trials ◽  
Chronic Migraine ◽  
Initial Treatment ◽  
Randomized Trials ◽  
Rapid Onset ◽  
Migraine Prevention ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Us ◽  
Prevention Trials

Background: Eptinezumab is approved in the US for migraine prevention. We demonstrate the consistency in migraine reduction from Day 1 across 4 weeks in patients with episodic (EM) or chronic migraine (CM) treated with eptinezumab. Methods: Four double-blind, placebo-controlled, randomized trials evaluated eptinezumab for migraine prevention: NCT01772524 (EM); NCT02559895 (EM, PROMISE-1); NCT02275117 (CM); NCT02974153 (CM, PROMISE-2). The percentage of patients experiencing migraine was evaluated on Day 1, then as an averaged daily occurrence weekly through Wk4; baseline was averaged over the 28-day screening period. Results: Approximately 31% of EM patients experienced migraine on any given day during baseline. PROMISE-1 percentages of patients with migraine on Day 1: 14.8% (100mg), 13.9% (300mg), 22.5% (placebo); during Wk4: 17.1%, 15.8%, 20.5%. NCT01772524 on Day 1: 4.8% (1000mg), 13.7% (placebo); during Wk4: 10.0%, 17.6%. Approximately 58-59% of CM patients experienced migraine on any given day during baseline. PROMISE-2 percentages on Day 1: 28.6% (100mg), 27.8% (300mg), 42.3% (placebo); during Wk4: 31.8%, 28.8%, 36.0%. NCT02275117 on Day 1: 29.3% (100mg), 26.5% (300mg), 48.7% (placebo); during Wk4: 30.2%, 30.1%, 41.0%. Conclusions: Across 4 migraine prevention trials, eptinezumab consistently demonstrated rapid onset of migraine preventive benefit, beginning Day 1 after initial treatment and sustained through ≥4 weeks.

Intranasal Fentanyl for Initial Treatment of a Vaso-Occlusive Crisis: A Randomized, Double-Blind, Placebo Controlled Trial

PEDIATRICS ◽  
2016 ◽  
Vol 137 (Supplement 3) ◽  
pp. 272A-272A
Author(s):  
Daniel M. Fein ◽  
Kathryn Scharbach ◽  
Deepa Manwani ◽  
Jeffrey R. Avner ◽  
Hnin Khine
Keyword(s):  
Initial Treatment ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study

2015 ◽  
Vol 14 (11) ◽  
pp. 1091-1100 ◽  
Author(s):  
Marcelo E Bigal ◽  
Lars Edvinsson ◽  
Alan M Rapoport ◽  
Richard B Lipton ◽  
Egilius L H Spierings ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Preventive Treatment ◽  
Double Blind ◽  
Double Blind Placebo

Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms

2019 ◽  
pp. 331-340
Author(s):  
Susan Churchill ◽  
◽  
Kayla Deru ◽  
Lindell K. Weaver ◽  
Steffanie H. Wilson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Hyperbaric Oxygen ◽  
Gas Flow ◽  
Randomized Trials ◽  
Symptom Improvement ◽  
Sham Control ◽  
Serious Adverse Events ◽  
Double Blind ◽  
To Receive

Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the BIMA study). Minor, non-limiting barotrauma was the most frequently reported. Rarely, some participants experienced headache with chamber sessions. No serious adverse events were associated with chamber sessions. An allocation questionnaire completed after intervention revealed that the sham control arm adequately protected the blind in both trials. Participants based allocation assumptions on symptom improvement or lack of symptom improvement and could not discern intervention arm by pressure, smell, taste, or gas flow.

scholarly journals Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials)

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Jessica Ailani ◽  
J. Scott Andrews ◽  
Mallikarjuna Rettiganti ◽  
Robert A. Nicholson
Keyword(s):  
Chronic Migraine ◽  
Migraine Headache ◽  
Pain Severity ◽  
Life Questionnaire ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Link Type ◽  
Total Pain ◽  
Maximum Pain ◽  
The Impact

Abstract Background Focus on the frequency of migraine pain may undervalue the total burden of migraine as pain duration and severity may present unique, additive burden. A composite measure of total pain burden (TPB; frequency, severity, and duration) may provide a more comprehensive characterization of pain burden and treatment response in patients with episodic migraine (EM) or chronic migraine (CM). The impact of galcanezumab versus placebo on TPB among patients with EM or CM was analyzed. Methods Patients from randomized, double-blind, placebo-controlled episodic (two 6-month studies pooled) and chronic migraine (3-month) studies received once-monthly subcutaneous injection of galcanezumab 120 mg or placebo. A post hoc analysis of TPB for a given month was calculated as severity-weighted duration by multiplying duration (hours) and maximum pain severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) of migraine for each day and summing these over the days in a month. Least square mean change from baseline in monthly TPB across Months 1–6 (EM, N = 444 galcanezumab, N = 894 placebo) and Months 1–3 (CM, N = 278 galcanezumab, N = 558 placebo) were compared using a mixed-model repeated measures model. Correlation of the Migraine Specific Quality of Life Questionnaire (MSQ) and Migraine Disability Assessment Scale (MIDAS) to TPB at baseline was assessed. Results At baseline, the duration of migraine on a given migraine headache day accounted for the greatest unique proportion of variability (EM, 57.4% and CM, 61.1%) to TPB after adjusting for frequency of migraine headache days and maximum pain severity. The decrease from baseline in monthly TPB was greater with galcanezumab than placebo for patients with EM (68.6 versus 36.2) and CM (102.6 versus 44.4). The average percent reduction of TPB from baseline was significantly greater with galcanezumab compared with placebo in patients with EM (50.8% versus 17.2%) and CM (29.7% versus 11.0%). In patients with EM and CM, TPB correlated with MSQ total score (r = − 0.35 and r = − 0.37) and MIDAS (r = 0.34 and r = 0.32). Conclusions Greater reduction in TPB was seen in patients with EM and CM treated with galcanezumab 120 mg once-monthly injection relative to placebo. Discussing TPB supports patient-centric conversations regarding treatment expectations when clinicians are evaluating options for migraine prevention. Trial registration ClinicalTrials.gov: #NCT02614183 (I5Q-MC-CGAG; EVOLVE-1), #NCT02614196 (I5Q-MC-CGAH; EVOLVE-2), and #NCT02614261 (I5Q-MC-CGAI; REGAIN) – all 3 trials were registered on 23 November 2015.

scholarly journals Adverse Event Burden Score—A Versatile Summary Measure for Cancer Clinical Trials

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3251
Author(s):  
Jennifer G. Le-Rademacher ◽  
Shauna Hillman ◽  
Elizabeth Storrick ◽  
Michelle R. Mahoney ◽  
Peter F. Thall ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Treatment Cycle ◽  
Controlled Trials ◽  
Cancer Clinical Trials ◽  
Weighted Sum ◽  
Summary Measure ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Over Time

This article introduces the adverse event (AE) burden score. The AE burden by treatment cycle is a weighted sum of all grades and AEs that the patient experienced in a cycle. The overall AE burden score is the total AE burden the patient experienced across all treatment cycles. AE data from two completed Alliance multi-center randomized double-blind placebo-controlled trials, with different AE profiles (NCCTG 97-24-51: 176 patients, and A091105: 83 patients), were utilized for illustration. Results of the AE burden score analyses corroborated the trials’ primary results. In 97-24-51, the overall AE burden for patients on the treatment arm was 2.2 points higher than those on the placebo arm, with a higher AE burden for patients who went off treatment early due to AE. Similarly, in A091105, the overall AE burden was 1.6 points higher on the treatment arm. On the placebo arms, the AE burden in 97-24-51 remained constant over time; and increased in later cycles in A091105, likely attributable to the increase in disease morbidity. The AE burden score enables statistical comparisons analogous to other quantitative endpoints in clinical trials, and can readily accommodate different trial settings, diseases, and treatments, with diverse AE profiles.

scholarly journals Patient Adherence and Efficacy of Certolizumab Pegol in the Management of Crohn's Disease

2012 ◽  
Vol 5 ◽  
pp. CGast.S7613 ◽  
Author(s):  
Wojciech Blonski ◽  
Anna M. Buchner ◽  
Gary R. Lichtenstein
Keyword(s):  
Tumor Necrosis ◽  
Maintenance Treatment ◽  
Patient Adherence ◽  
Certolizumab Pegol ◽  
Controlled Trials ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Us ◽  
Necrosis Factor ◽  
Adherence To Therapy

Treatment with Anti-Tumor Necrosis Factor (anti-TNF) therapy has become a mainstay of therapy for patients with CD who are unresponsive to conventional medical management. Currently there are three anti-TNFα antibodies that have been approved by the US Food and Drug Administration for the treatment of CD, namely infliximab, adalimumab and certolizumab pegol (CZP). Several double blind placebo controlled trials determined that CZP is effective as induction and maintenance treatment in adult patients with CD regardless of their prior exposure to other anti-TNFα antibodies. This review discusses the efficacy of CZP and adherence to therapy with anti-TNFα antibodies in patients with CD.

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