RIMEGEPANT for Migraine | Episodic migraine

Inclusion criteria

• {"criterion_text":"- Participant has at least a 6-month history of migraine (with or without aura) consistent with a Diagnosis according to the International Classification of Headache Disorders, 3rd Edition, and including the following: - 14 or less headache days per month during the 3-month period prior to the Screening Visit. - 6 or more migraine days during the Observation Period. - 14 or less headache days during the Observation Period. - Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to ≤50 at the Baseline (Randomization) Visit. - Participants on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study."}
• {"criterion_text":"- Participants must have a weight of >15 kg. For EU countries only: Participants of 12 to <18 years of age must have a body weight >25 kg."}
• {"criterion_text":"- Male and female participants 6 to <18 years; participants must be less than 18 at the time of signing assent / consent. Participants must not reach their 18th birthday on or before the Randomization (Baseline) visit. The participant, if a female who is sexually active and of childbearing potential must be willing to use one effective method of contraception to avoid pregnancy throughout the study."}
• {"criterion_text":"- No clinically significant abnormality identified on the medical or laboratory evaluation. A participant 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."}
• {"criterion_text":"- Signed written Informed Consent/Assent (where applicable, according to local regulations) prior to the conduct of any study-specific procedures."}

Exclusion criteria

• {"criterion_text":"- Participants with a history of basilar migraine, cluster headaches, or hemiplegic migraine, continuous migraine within 1 month prior to Screening Visit, history or diagnosis of complications of migraine, chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration)."}
• {"criterion_text":"- The participant has a history of severe drug allergy or hypersensitivity or known hypersensitivity or intolerance to the excipients in rimegepant. History of anaphylaxis, documented hypersensitivity reaction, or clinically significant reaction to any drug."}
• {"criterion_text":"- Clinically significant abnormality identified on the medical or laboratory evaluation. The following laboratory results are exclusionary: • Serum creatinine value >1.5 times the upper limit of the reference range (ULN). • Serum total bilirubin > ULN, unless the participant has known or suspected Gilbert’s syndrome. • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x ULN. AST and/or ALT may be repeated once during the screening period for assessment of eligibility."}
• {"criterion_text":"- Any “yes” response on the Columbia-Suicide Severity Rating Scale (C-SSRS) for the period of 30 days prior to Screening."}
• {"criterion_text":"- The participant has a disease or takes medication that could, in the investigator’s opinion, interfere with the assessments of safety or tolerability, or interfere with the conduct or interpretation of the study."}
• {"criterion_text":"- The participant has a confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study. History of major psychiatric disorder or any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded. History of suicidal behavior or the participant is at risk of self-harm or harm to others."}
• {"criterion_text":"- The participant has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (DSM-5®19 criteria) < 2 years prior to the Screening Visit, as verified with legal representative(s) and in the opinion of the Investigator."}
• {"criterion_text":"- The participant has a history of cancer."}
• {"criterion_text":"- The participant has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator’s opinion, likely to affect central nervous system functioning."}
• {"criterion_text":"- The participant has or has had medical conditions that is/are considered clinically relevant in the context of the study."}
• {"criterion_text":"- The participant has one or more clinically significant out-of-range vital signs at the Screening or Baseline (Randomization) Visit."}
• {"criterion_text":"- The participant has a current diagnosis of viral hepatitis or a history of liver disease."}
• {"criterion_text":"- The participant has a known history of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus (HIV), unless the participant has a CD4+ count >200 and undetectable viral load."}

Primary endpoints

• {"endpoint_text":"- Mean change from baseline (observation period, OP) in the number of migraine days per month over the entire DBT phase (Weeks 1 to 12) in adolescents with episodic migraine.","definition_or_measurement_approach":"Mean change from the observation period (OP) in the number of migraine days per month over Weeks 1 to 12 of the double-blind treatment (DBT) phase. A month is defined as 4 weeks for the purpose of the protocol."}

Secondary endpoints

• {"endpoint_text":"- Percentage of participants with ≥50% reduction from the OP in the number of moderate to severe migraine days per month over the entire DBT phase in adolescents with episodic migraine.","definition_or_measurement_approach":"Proportion of participants achieving at least a 50% reduction from the observation period in the number of moderate to severe migraine days per month over Weeks 1 to 12."}
• {"endpoint_text":"- Mean change from the OP in the number of moderate to severe headache days per month over the entire DBT phase in adolescents with episodic migraine.","definition_or_measurement_approach":"Mean reduction from the observation period in number of moderate to severe headache days per month over Weeks 1 to 12 of DBT."}
• {"endpoint_text":"- Mean change from the OP in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT phase in adolescents with episodic migraine.","definition_or_measurement_approach":"Mean change from OP in number of migraine days per month calculated for Weeks 1 to 4 of DBT."}
• {"endpoint_text":"- Mean change from baseline in the Pediatric Quality of Life (PedsQLTM) total score at Week 12 of the DBT phase in adolescents with episodic migraine.","definition_or_measurement_approach":"Change from baseline in PedsQL 4.0 Generic Core Scales total score measured at Week 12 of DBT."}

Methods

• Digital campaigns / AutoCruitment Digital Campaign materials (online digital advertising targeted to potential participants and caregivers).
• 2D animated videos (participant-facing and assent-focused animated videos) to explain the study and assent process.
• Participant invite letters and HCP referral letters for clinician referrals.
• Study posters and outreach media boards for site use.
• Phone screener (AutoCruitment Phone Screener) for pre-screening by phone.
• Study brochures and study visit guides provided to participants/caregivers.
• Site-based recruitment via hospital/clinic neurology and pediatric departments (site referral).

Spain

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

558

Number Of Sites

7

Number Of Participants

20

France

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

07-01-2026

Processing Time Days

573

Number Of Sites

3

Number Of Participants

15

Italy

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

699

Number Of Sites

10

Number Of Participants

95

Poland

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

701

Number Of Sites

7

Number Of Participants

285

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Pharmaceutical Product Development LLC

Responsibilities

Pharmacovigilance

Name

Syneos Health Netherlands B.V.

Responsibilities

sponsorDuties codes: 1,2,7 (country legal/operations support)

Name

Imperial Clinical Research Services International Ltd.

Responsibilities

Printing Vendor / operational support

Name

4g Clinical LLC

Responsibilities

IVRS – treatment randomisation

Name

Eresearchtechnology Inc.

Responsibilities

ECG analysis/review

Name

Cytel Inc.

Responsibilities

Statistical/analysis support (sponsorDuties code 10)

Third parties

• {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"sponsorDuties codes: 4 (contact awillsey@acmgloballab.com)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7 (Ronima.AICH@3ds.com)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Pharmacovigilance","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG analysis/ review","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA (eDiary)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IVRS30 – treatment randomisation","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"Printing Vendor","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"sponsorDuties codes: 10 (support@cytel.com)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Pharmaspecific","duties_or_roles":"Patient Travel Reimbursement","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"sponsorDuties codes: 1, 2, 7 (LegalRepContact@syneoshealth.com)","organisation_type":"Pharmaceutical company"}