Trial for Treatment Refractory Trigeminal Neuralgia
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|ClinicalTrials.gov Identifier: NCT03941834|
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Neuralgia||Drug: Rimegepant Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuraligia|
|Actual Study Start Date :||June 25, 2019|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||February 1, 2020|
|Active Comparator: BHV3000||
BHV3000 (rimegepant) 75mg tablet
|Placebo Comparator: Placebo||
- Efficacy of BHV-3000 compared to placebo in providing symptomatic pain relief in patients with refractory Trigeminal Neuralgia, as measured by a 2-point or greater reduction in the average Numeric Pain Rating Scale. [ Time Frame: From Baseline to End of Randomization Phase, up to 5 weeks. ]Change in mean NPRS between the treatment phase. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
- Safety and tolerability (Incidence of treatment emergent adverse events) of BHV-3000 relative to placebo in patients with Trigeminal Neuralgia [ Time Frame: From Baseline to End of Randomization Phase up to 5 weeks. ]Safety and tolerability will be measured by the frequency and severity of adverse events and discontinuations due to adverse events.
- Efficacy of BHV-3000 vs placebo for improving physical function in Trigeminal Neuralgia patients as measured by the Penn Facial Pain Scale-Revised [ Time Frame: From Baseline to End of Randomization Phase ]12 questions in which the higher the score the more pain and disability
- Efficacy of BHV-3000 vs placebo for improving functional disability in Trigeminal Neuralgia patients as measured by the Pain Disability Index [ Time Frame: From Baseline to End of Randomization Phase, up to 5 weeks. ]7 question's that are Scored 0-10, ten being more disabled.
- Efficacy of BHV-3000 vs placebo on global functioning as measured by the Patient Global Impression of Change Scale. [ Time Frame: From Baseline to End of Randomization Phase, up to 5 weeks. ]Measured by a likert scale from No change to a great deal better.
- Efficacy of BHV-3000 vs placebo in improving emotional functioning as measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: From Randomization to end of treatment period, up to 5 weeks. ]The higher the HADS score the more anxious and/or depressed
- Efficacy of BHV-3000 vs placebo in providing pain relief as captured by daily rating of worst pain episode as measured by the 11 point numeric rating scale. [ Time Frame: From Baseline to End of Randomization Phase, up to 5 weeks. ]11 point numeric rating scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941834
|Contact: Elyse Stock, MDemail@example.com|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Whitney Isennock 410-955-7008 firstname.lastname@example.org|