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A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

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ClinicalTrials.gov Identifier: NCT04804033
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : March 29, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

Condition or disease Intervention/treatment Phase
Migraine Drug: BHV-3500 (zavegepant) Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2/3 Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
Actual Study Start Date : March 26, 2021
Estimated Primary Completion Date : December 15, 2027
Estimated Study Completion Date : December 15, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: BHV-3500 200mg
Zavegepant 200mg oral soft gel capsule.
 Drug: BHV-3500 (zavegepant)
BHV-3500 (zavegepant) softgel capsule.
Placebo Comparator: Placebo 200mg
Matching placebo 200mg oral soft gel capsule.
 Drug: Placebo
Matching placebo softgel capsule.
Active Comparator: BHV-3500 100mg
Zavegepant 100mg oral soft gel capsule.
 Drug: BHV-3500 (zavegepant)
BHV-3500 (zavegepant) softgel capsule.
Placebo Comparator: Placebo 100mg
Matching placebo 100mg oral soft gel capsule.
 Drug: Placebo
Matching placebo softgel capsule.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of zavegepant compared to placebo as a preventive treatment for migraine [ Time Frame: Number of migraine during weeks 1 to 12 ]
    Measured by the mean reduction from baseline (i.e., Observation Phase) in the number of migraine days per month over the entire Double-blind Treatment Phase.


Secondary Outcome Measures :
  1. Efficacy of zavegepant compared to placebo with the number of subjects that had a ≥ 50% reduction from Observational Phase. [ Time Frame: Number of migraine days during weeks 1 to 12 ]
    Measured by the number of moderate to severe migraine days per month over the entire double-blind treatment phase.

  2. Efficacy of zavegepant to placebo on mean reduction from Observational Phase. [ Time Frame: Number of migraine days during per month during weeks 9 to 12 ]
    Measured by the number of migraine days in the last 4 weeks of the Double-Blind Treatment Phase.

  3. Efficacy of zavegepant to placebo on mean reduction from Observational Phase. [ Time Frame: Number of migraine days per month during weeks 1 to 4 ]
    Measured by the number of migraine days per month in the first 4 weeks of the Double-Blind Treatment Phase.

  4. Efficacy of zavegepant to placebo in the mean number of acute migraine specific medication days per month. [ Time Frame: Number of migraine days per month during weeks 1 to 12 ]
    Measured by the number of acute migraine specific medication days over the entire Double-Blind Treatment Phase.

  5. Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase. [ Time Frame: Week 12 of the double-blind treatment phase. ]
    The change from baseline is calculated as the MSQoL restrictive role function domain score at Week 12 of the DBT phase minus the MSQoL restrictive role function domain score at baseline.

  6. Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase. [ Time Frame: Week 12 of the double-blind treatment phase. ]
    The change from baseline is calculated as the MIDAS total score at Week 12 of the DBT phase minus the MIDAS total score at baseline.

  7. Evaluate the safety and tolerability of zavegepant. [ Time Frame: From Baseline through Week 12 ]
    This will be evaluated by the number of participants with treatment related adverse events by severity measured as mild, moderate, or severe.

  8. The frequency of ALT or AST elevations > 3x ULN, concurrently with bilirubin elevations > 2x ULN in subjects treated with zavegepent during the double-blind and open label phases. [ Time Frame: From Baseline through Week 12 ]
  9. The frequency of hepatic related adverse events. [ Time Frame: From Baseline through Week 12 ]
    Measured by discontinuations in subjects treated with zavegepant due to elevated Liver Function Tests during the double-blind and open label phases


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of

Headache Disorders, 3rd Edition, including the following:

  1. Age of onset of migraines prior to 50 years of age
  2. Migraine attacks, on average, lasting 4 - 72 hours if untreated
  3. Per subject report, at least 15 headache days per month, at lest 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit
  4. Eight or more migraine days during the Observation Period
  5. 15 or more headache days during the Observation Period
  6. One or more non-headache days during the Observation Period
  7. Ability to distinguish migraine attacks from tension/cluster headaches
  8. Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.

Exclusion Criteria:

  1. Subject with a history of HIV disease
  2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
  3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
  4. Subjects with major depressive episode or anxiety disorder which require more than 1 daily medication for each disorder or subjects with a major depressive episode within the last 12 months. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit.
  5. Subjects with active chronic pain syndromes, other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion interfere with study assessments of safety or efficacy.
  6. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
  7. Body mass index > 33 kg/m2
  8. History of gallstones or cholecystectomy.
  9. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04804033


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04804033    
Other Study ID Numbers: BHV3500-302
C5301006 ( Other Identifier: Pfizer )
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Migraine Prevention
Phonophobia
Photophobia
Nausea
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases