The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

Phase 1

• Conditions: Acute Migraine (with or without aura); MedDRA version: 20.0Level: PTClassification code 10052787Term: Migraine without auraSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10027607Term: Migraine with auraSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-005239-22-PL
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-03
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

1.Signed Written Informed Consent
a) Written informed consent must be obtained from the subject in accordance with requirements of the study center's institutional review board (IRB) or ethics committee, prior to the initiation of any protocol required procedures.
2.Target Population
Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition4, including the following:
a) Age of onset of migraines prior to 50 years of age.
b) Migraine attacks, on average, lasting 4 - 72 hours if untreated.
c) Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol).
d) 4 or more migraine days during 28 days in the Observation Phase.
e) Not more than 14 headache days during 28 days in the Observation Phase.
f) Ability to distinguish migraine attacks from tension/cluster headaches.
g) Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
3.Age and Reproductive Status
a) Male and female subjects = 18 years.
b) Women of childbearing potential (WOCBP) and non-sterile men must be using two acceptable methods of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. See Section 5.6 for the definition of WOCBP. Males with vasectomy are considered surgically sterile provided the procedure occurred greater than 6 months (24 weeks) prior to study participation.
c) At the Baseline Visit, WOCBP must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) before dosing with study drug.
4. No clinically significant abnormality identified on the medical 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 factors, nor interfere with the study procedures (not including exclusion criteria listed in Section 5.3 of the protocol).
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 624
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

1. Target Disease Exclusion
a) Subject has a history of basilar migraine, hemiplegic migraine, retinal migraine or migraine accompanied by diplopia or decreased level of consciousness as defined by International Classification of Headache Disorders, 3rd Edition.
b) Subjects with headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit.
2.Medical History and Concurrent Diseases
a)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, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to the Screening Visit.
b)Uncontrolled hypertension or uncontrolled diabetes. However, subjects can be included who have stable hypertension and/or diabetes for 3 months prior to the Screening Visit. Blood pressure greater than 150 mmHg systolic or 100 mmHg diastolic after 10 minutes of rest is exclusionary. This may be repeated once at screening once during visit to confirm reproducibility.
c)Subjects with major depressive or any anxiety disorder which require more than 1 daily medication for each disorder or subjects with major depressive episode within 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.
d)Active chronic pain syndromes
e)Subjects with other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere
with study assessments of safety or efficacy.
f)Diagnosis of active biliary disorder.
g)Subject has a history of gastric, or small intestinal surgery, or has a disease or condition that causes malabsorption.
h)Subject has a history or diagnosis of any active hepatic disorder.
i)The subject has a history or current evidence of any unstable medical conditions that, in the investigator's opinion, would expose them to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the study.
j)History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria10 for any significant substance use disorder within the past 12 months from the Screening Visit according to PI assessment.
k)History of use of narcotics, such as opioids for =4 days per month during the 3 months prior to the Screening Visit.
l)Subjects should be excluded if they have a positive drug screen 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.
m)Hematologic or solid malignancy diagnosis within 5 years prior to the Screening Visit. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancerfree prior to the Screening Visit in this study.
n)Subject has current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
o)Body mass index > 35.0 kg/m2.
3.History of anaphylaxis to any substa

Study & Design

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