A Study to Evaluate the Efficacy and Tolerability of Rimegepant for Acute Migraine Attacks in Adults for whom Triptans are unsuitable

Phase 1

• Conditions: migraine attacks with or without aura; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2022-001175-14-AT
• Lead Sponsor: Pfizer, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-20
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. 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

2. Triptan unsuitable

3. Age and Reproductive Status
a. Male and Female subjects >=18 years of age
b. Women of childbearing potential (WOCBP) with non-sterile male partners and non-sterile men with female partners of childbearing potential must use two methods of contraception (with at least 1 highly effective method and 1 additional method) to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized
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)
4. 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 570
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. 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 non-migraine) in any of the 3 months prior to Screening Visit (SV)
2. 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
3. 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 a hypersensitivity to any component of its formulation.
4. 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
5. ECG and Laboratory Test Findings - as specified in the protocol

6. Prohibited Medications and Devices
a) Non-Narcotic Analgesics taken at least 15 days per month for a non-headache indication during the 12 weeks prior to SV
b) Other CGRP antagonists (beyond rimegepant), including:
i.CGRP antagonist monoclonal antibodies taken within 24 weeks prior SV
ii.CGRP antagonist small molecules taken within 10 days prior SV
c)Botulinum toxin injections (e.g., Botox®) used for the prevention of migraine taken within 3 months (12 weeks) prior to the SV
d)Cefaly or any other device for migraine treatment or prevention used within 12 weeks prior SV
e)Ergotamine taken at least 10 days per month on a regular basis for at least 12 weeks in the year prior SV
f)Narcotics, such as opioids or barbiturates taken at least 4 days per month during 12 weeks prior SV
g)Permitted acute migraine medication taken at least 15 days per month for a non-migraine indication during 12 weeks prior SV
7. Other:
a) Exposure to non-biological investigational agents within 30 days prior SV
b) Exposure to biological investigational agents within 24 weeks prior SV
c) Subjects who meet criteria for C-SSRS Suicidal Ideation Items 4 or 5 within the last 12 months OR subjects who endorse any of the 5 C-SSRS Suicidal Behavior Items within t

Study & Design

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