RIMEGEPANT for Acute migraine

Inclusion criteria

• {"criterion_text":"- History of migraine (with or without aura) for ≥ 6 months before Screening.\n- History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.\n- Participant had 1 or more migraine days requiring treatment during the Observation Phase.\n- Participants on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 12 weeks prior to the Screening Visit.\n- Participants are required to verbally distinguish between migraine and other types of headaches.\n- Participants must have a body weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25 kg.\n- Participants must have adequate venous access for blood sampling. 8.\n- Participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before enrollment into the study).Baseline visit)."}

Exclusion criteria

• {"criterion_text":"- Participant has a history of cluster headache or hemiplegic migraine headache. 2.\n- The participant has a confounding and clinically significant pain syndrome that may interfere with their ability to participate in this study.\n- The participant has 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.\n- History of suicidal behavior or the participant is at risk of self-harm or harm to others.\n- History of major psychiatric disorder.\n- The participant has a current diagnosis or history of substance abuse.\n- The participant has reported current use of or has tested positive at the Screening visit for drugs of abuse."}

Primary endpoints

• {"endpoint_text":"- The frequency and severity of on-treatment and treatment-emergent adverse events (TEAEs) that occur in at least 5% of treated participants, the frequency of serious adverse events (SAEs) , adverse events (AEs) leading to discontinuation and clinically significant laboratory abnormalities during the treatment period will be assessed. Clinically significant laboratory abnormalities will be identified as on-treatment Grade 3 to 4 laboratory test results.","definition_or_measurement_approach":"Assessment of frequency and severity of on-treatment and treatment-emergent adverse events (TEAEs) occurring in ≥5% of treated participants; frequency of SAEs; AEs leading to discontinuation; clinically significant laboratory abnormalities defined as on-treatment Grade 3 to 4 laboratory test results."}

Secondary endpoints

• {"endpoint_text":"- The frequency and severity of hepatic-related adverse events (AEs) and frequency of hepatic-related AEs leading to treatment discontinuation will be tabulated from case report forms and will be based on unique participants reporting such events. Severity will be assessed as the worst severity observed while the participant is on treatment.","definition_or_measurement_approach":"Hepatic-related AEs tabulated from case report forms based on unique participants; frequency of hepatic-related AEs leading to treatment discontinuation; severity assessed as worst severity observed while participant is on treatment."}

Spain

Earliest CTIS Part Ii Submission Date

22-05-2024

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

656

Number Of Sites

3

Number Of Participants

38

Poland

Earliest CTIS Part Ii Submission Date

22-05-2024

Latest Decision Or Authorization Date

08-03-2026

Processing Time Days

655

Number Of Sites

5

Number Of Participants

60

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Q Squared Solutions Limited

Responsibilities

Central Laboratory services

Name

Endpoint Clinical Inc.

Responsibilities

IVRS - treatment randomization

Name

Eresearchtechnology Inc.

Responsibilities

Cardiac Safety Assessment: central ECG services; eDiary solutions provider

Name

Syneos Health Netherlands B.V.

Responsibilities

Vendor management and other vendor/CRO services

Third parties

• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Laboratory services","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS - treatment randomization","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac Safety Assessment: central ECG services; eDiary solutions provider","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Vendor management; (other duties coded: 1, 5, 6 in record)","organisation_type":"Pharmaceutical company"}