C4951004 - BHV3000-406: A Phase 4, Randomized, Double-blind Placebo Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Phase 1

Recruiting

• Conditions: Migraine attacks with or without aura; MedDRA version: 20.0Level: PTClassification code: 10027599Term: Migraine Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2024-513269-37-00
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-28
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 564

Inclusion Criteria

Target Population: Minimum 1 year documented history of migraine attacks (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition Per self-report, with confirmation from Investigator / supporting medication record, subjects must have: a. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age b. Migraine attacks, on average, lasting about 4 - 72 hours if untreated c. 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol) d. Subjects must be able to distinguish migraine attacks from tension headaches e. Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study, Triptan unsuitable, Age and Reproductive Status a. Subjects = 18 years of age b. Subject meets reproductive criteria. Refer to Appendix 5 c. At the Baseline Visit prior to dispensing investigational study drug, WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG), Subjects must be able to fully comply with the prohibitions and restrictions on the concomitant use of medications and therapies (including moderate to strong inhibitors and inducers of the CYP3A4 enzyme and strong inhibitiors of the P-gp transporter). For further inclusion criteria, please refer to the Protocol.

Exclusion Criteria

Target Disease Exclusion a. History of cluster headaches, basilar migraine (with aura), or hemiplegic migraine b. Current medication overuse headaches c. Headaches occurring 15 or more days per month (migraine or nonmigraine) in any of the 3 months prior to Screening Visit (SV) d. 7 or more non-migraine headache days per month, on-average, across the 3-months prior to the Screening Visit, Medical History and Current Diseases: a. History of gastric or small intestinal surgery or disease or conditions that causes malabsorption b. BMI = 35kg/m2 c. Alcohol or drug abuse within the past 12 months or subjects with any significant substance use disorder within the 12 months from the SV d. Current diagnosis schizophrenia, bipolar, or borderline personality disorder e. History or current evidence of other major psychiatric disorder that might interfere with the ability to properly report clinical outcomes f. Major depressive (MDD) or any anxiety disorder which requires more than 1 daily medication for each disorder, or major depressive episode within last 12 months g. Active chronic pain syndrome h. Other pain syndromes, dementia, or significant neurological disorders (other than migraine) i. Current diagnosis of MDD requiring treatment with atypical antipsychotics j. History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease during 24 weeks prior to SV k. Systolic blood pressure >150 mmHg or diastolic blood pressure > 100 mmHg after 10 minutes of rest l. History or current evidence of any unstable medical conditions m. Positive for drugs of abuse that in the investigator's judgment is medically significant, in that it would impact the safety of the subject or the interpretation of the study results, Allergies and Adverse Drug Reactions: History of drug or other allergy which, in the opinion of the investigator, makes the subject unsuitable for participation in the study. Rimegepant is contraindicated in subjects with hypersensitivity to any component of its formulation., Sex and Reproductive Status: a.WOCBP who are unwilling or unable to use required contraception b. Women who are pregnant, lactating or breastfeeding c. Women with a positive pregnancy test at SV or prior to study drug administration, ECG and Laboratory Test Findings a. Any clinically significant abnormality identified on the medical, ECG or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the Investigator considers the finding not clinically significant, that it will not introduce additional risk, nor interfere with the study procedures (not including exclusion criteria listed in Section 5.3). b. Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation <30 ml/min/1.73m2. c. Total bilirubin >1.5 x ULN (For Gilbert’s syndrome, direct bilirubin >ULN is exclusionary). d. AST and ALT >2 x ULN. e. Serum albumin <2.8g/dL f. Neutrophil count = 1000/µL (or equivalent) g. HbA1c >7.5% h. Evidence of organ dysfunction or any clinically significant deviation from normal on physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with the target population, Prohibited Medications and Devices a. Non-Narcotic Analgesics taken at least 15 days per month for a nonheadache indication durin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified