RIMEGEPANT SULFATE for Chronic migraine

Inclusion criteria

• {"criterion_text":"- Age and Sex: 1. Participants aged 12 to <18 years at the time of signing assent/consent. Participants must not reach their 18th birthday on or before the Randomization (Baseline) visit. • For EU countries and India ONLY: Participants must weigh greater than 40 kg\n- Disease Characteristics: 2. 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 Edition1 including the following: • 15 or more headache days per month during the 3-month period prior to the Screening Visit. • 8 or more migraine days per month during the 3-month period prior to the Screening Visit. • 15 or more headache days during the OP. • 8 or more migraine days during the OP. • Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches. • Migraine attacks, on average, lasting 4 to 72 hours if untreated.\n- Other Inclusion Criteria: 3. Signed Written Informed Consent: • The participant is able to understand the Informed Assent Document (IAD) and the participant’s parent(s)/legal representative(s) (according to local regulations) are/is able to read and understand the Informed Consent Document (ICD). • The participant has signed the IAD/ICD (according to local regulations) and the participant’s parent(s)/legal representative(s) have/has signed the ICD prior to the conduct of any study-specific procedures. • The participant must be able to read and comprehend written instructions and be willing to complete all questionnaires under supervision of legal representative(s) as required by the protocol."}

Exclusion criteria

• {"criterion_text":"- Target Disease Exclusion: • Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit. • Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study as assessed by the principal investigator (PI).\n- The following laboratory/electrocardiogram (ECG) values are exclusionary during the screening period: •\tEstimated glomerular filtration rate (eGFR)/creatinine clearance (CrCl) <45 mL/min/1.73m2. •\tSerum total bilirubin > upper limit of normal (ULN) (unless participant has known or suspected Gilbert’s Syndrome). •\tAspartate 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). •\tAn abnormal ECG at the screening visit that is clinically significant based on the investigator’s evaluation of the central reader’s interpretation. Determinations of eligibility based on QT interval will be based on the Fridericia correction where QTcF= QT/(RR⁰.³³).\n- Any medical condition or laboratory abnormality, including any clinically significant out-of-range vital signs, that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study (see Exclusion #10 for key parameters assessments for liver and renal function, and for cardiac evaluation).\n- Any current psychiatric condition that is uncontrolled and/or untreated.\n- Any “yes” response on the C-SSRS for the period of 30 days prior to Screening.\n- History of alcohol abuse and/or illicit drug use meeting DSM-5®² criteria for substance use disorder within 6 months of screening (excluding nicotine and caffeine). • Positive at screening for drugs of abuse, and who are on a prescribed medication for an approved indication (eg, ADHD), will be allowed into the study at the investigator’s discretion. This determination by the investigator must be well documented in the source medical records. The stimulant dose must be stable from 3 months prior to baseline until the end of treatment visit occurs.\n- History of severe drug allergy (such as anaphylaxis, or known hypersensitivity or intolerance to rimegepant or its excipients).\n- Current use of any prohibited concomitant medication(s).\n- More than 1 medication taken for migraine prevention/prophylaxis. • Concomitant use of a CGRP receptor antagonist, such as Nurtec™ or others, monoclonal antibodies such as erenumab, fremanezumab, or others <6 months prior to the Screening Visit. • Prophylactic migraine medication discontinued less than 30 days prior to the Screening Visit. • Prophylactic migraine medication not being stable for at least 3 months (12 weeks) prior to the OP, or dose expected to change during the course of the study.\n- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products at any time during participation in this study is also exclusionary."}

Primary endpoints

• {"endpoint_text":"- Mean change from the observation phase (OP) in the number of migraine days per month over the entire double-blind treatment (DBT) Phase (Weeks 1 to 12).","definition_or_measurement_approach":"Mean change from the observation phase (OP) in the number of migraine days per month measured over the entire double-blind treatment Phase (Weeks 1–12); comparison of rimegepant versus placebo in adolescents with chronic migraine."}

Secondary endpoints

• {"endpoint_text":"- Mean change from the OP in the number of acute migraine-specific medication days per month over the entire DBT Phase (Weeks 1 to 12).\n- Mean change from the OP in the number of moderate or severe headache days per month over the entire DBT Phase (Weeks 1 to 12).\n- Percentage of participants with ≥50% reduction from the OP in the number of moderate or severe migraine days per month over the entire DBT Phase (Weeks 1 to 12).\n- Mean change from baseline in the PedsQL™ 4.0 Generic Core Scales total score at Week 12 of the DBT Phase.\n- Mean change from the OP in the number of acute headache medication days per month and acute migraine-specific medication days per month in each month and over the entire DBT Phase.\n- The number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to study intervention discontinuation and grade 3 to 4 laboratory test abnormalities on treatment during the DBT and open-label extension (OLE) Phases.\n- The number and percentage of participants with hepatic-relate AEs and hepatic-related AEs leading to study intervention discontinuation on treatment during the DBT and OLE Phases.\n- Mean change from baseline in the PedMIDAS total score at Week 12 of the DBT Phase.","definition_or_measurement_approach":"Each secondary endpoint is defined in relation to either change from the observation phase (OP) or change from baseline measured during the DBT Phase (Weeks 1–12) or at Week 12 (for PedsQL and PedMIDAS). Safety endpoints capture counts and percentages of AEs/SAEs and laboratory abnormalities during DBT and OLE phases. Specific measures: change in days/month for medication or headache frequency; percentage achieving ≥50% reduction versus OP; mean score changes for PedsQL and PedMIDAS."}

Methods

• AutoRecruitment digital campaign materials (digital advertising/campaign assets as referenced by files named AutoCruitment / AutoRecruitment Digital Campaign Materials).
• AutoRecruitment cookie language and privacy policy (digital cookie/privacy handling for online recruitment).
• Phone screener (AutoCruitment Phone Screener / Phone Screener) to pre-screen potential participants by phone.
• Participant invite letters (site to patient invite letters / participant invite letter) distributed by sites.
• Study posters and brochures (Study Poster, Study Brochure) for site-based recruitment.
• 2D animated videos and study videos (Understanding Study Video, Migraine Study Medicine Video, What To Expect videos) for participant education and assent/consent support.
• Site outreach media board and image libraries for site use (Migraine Outreach Media Board / Image Library).
• Informed assent process materials and parent information materials (Informed Assent Process videos and Parent ICD / Assent documents) provided to adolescents and parents/legal representatives.

Czechia

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

21-10-2024

Processing Time Days

31

Number Of Sites

5

Number Of Participants

7

Finland

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

21-10-2024

Processing Time Days

28

Number Of Sites

7

Number Of Participants

9

Hungary

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

22-10-2024

Processing Time Days

32

Number Of Sites

5

Number Of Participants

7

Italy

Earliest CTIS Part Ii Submission Date

12-07-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

98

Number Of Sites

8

Number Of Participants

17

Spain

Earliest CTIS Part Ii Submission Date

17-09-2024

Latest Decision Or Authorization Date

21-10-2024

Processing Time Days

34

Number Of Sites

7

Number Of Participants

14

Poland

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

22-10-2024

Processing Time Days

32

Number Of Sites

9

Number Of Participants

17

Slovakia

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

23-10-2024

Processing Time Days

13

Number Of Sites

6

Number Of Participants

9

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Clario

Responsibilities

ECG - Central Reader/Reading Service

Name

Labcorp Central Laboratory Services LP

Responsibilities

Central Laboratory Services

Name

Iqvia Holdings Inc.

Responsibilities

Electronic COA (eCOA) Support Services, Translation Services

Third parties

• {"country":"United States","full_name":"Clario","duties_or_roles":"ECG - Central Reader/Reading Service","organisation_type":"Health care"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory Services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"Electronic COA (eCOA) Support Services, Translation Services","organisation_type":"Pharmaceutical company"}