Phase 3
N=241
A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants
Acute Migraine
Bottom Line
View on ClinicalTrials.gov: NCT05371652 ↗Enrolled (actual)
241
Serious AEs
2.9%
Results posted
Feb 2025
Primary outcome: Primary: Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 203 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rimegepant 75mg Orally Disintegrating Tablets (ODT) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
203 | — |
| PRIMARY Follow-up Safety Period: Number of Participants With TEAEs |
24 | — |
| PRIMARY Treatment Safety Period: Number of Participants With Serious Adverse Events (SAEs) |
7 | — |
| PRIMARY Follow-up Safety Period: Number of Participants With SAEs |
— | — |
| PRIMARY Treatment Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation |
1 | — |
| PRIMARY Follow-up Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation |
— | — |
| PRIMARY Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities |
225; 6; 0; 0 | — |
| PRIMARY Follow-up Safety Period: Number of Participants With ECG Abnormalities |
209; 2; 0; 2 | — |
| PRIMARY Treatment Safety Period: Number of Participants With Vital Signs Abnormalities |
12; 9; 1; 17; 0; 0 | — |
| PRIMARY Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. |
1; 1; 0; 5; 0; 0 | — |
| PRIMARY Treatment Safety Period: Number of Participants With Hematology Test Abnormalities |
0; 1; 0; 1; 0; 1 | — |
| PRIMARY Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period |
-1.7; -2.4; -3.4; -3.7; -4.4; -4.8 | — |
Summary
This trial is to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with migraine
Eligibility Criteria
Inclusion Criteria
At least a one-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition beta version, including the following:
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4 - 72 hours if untreated
- 6-18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit
- 6 or more migraine days requiring treatment during Observation Phase
- Ability to distinguish migraine attacks from tension/cluster headaches
- Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable dose for at least 2 months prior to the Baseline Visit, and the dose is not expected to change during the course of the study. subjects who previously discontinued prophylactic migraine medication must have done so at least 5 half-lives of the prophylactic medication prior to the Screening Visit
- Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria
Age and Reproductive Status:
- Male or female subjects ≥ 18 years
- Women of childbearing potential (WOCBP) must voluntarily use 1 acceptable methods of contraception to avoid pregnancy and to minimize the risk of pregnancy from signing of informed consent through 28 days after study drug administration. WOCBP is defined in Section 12.3. No contraception methods are required for male subjects in this study.
Exclusion Criteria
Target Disease Exclusion:
- Subjects has a history of basilar migraine with brain stem aura or hemiplegic migraine
Medical History and Comorbidities:
- History of HIV disease
- Current evidence of poorly controlled, unstable, or recently diagnosed cardiovascular or cerebrovascular disease such as ischemic heart disease, coronary vasospasm, and cerebral ischemia. Myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke, or transient ischemic attack (TIA) during 6 months prior to screening
- Poorly controlled hypertension (high blood pressure) or poorly controlled diabetes (but subjects with stable hypertension and/or diabetes for at least 3 months prior to screening may be included in the study). Blood pressure greater than 150 mmHg systolic or 100 mmHg diastolic after 10 minutes of rest is exclusionary
- Subjects with a current diagnosis of major depression or a major depressive episode within the last 12 months, other pain syndromes, psychiatric disorders, dementia, or significant neurological disorders (other than migraine) that, in the opinion of the investigator, might interfere with study assessments
- History of gastric or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric water ball, etc.) or diseases resulting in malabsorption
- Subject has a history or diagnosis of Gilibert's Syndrome or any other active hepatic or biliary disorder
- History or presence of significant and/or unstable medical conditions (e.g., history of congenital heart disease or cardiac arrhythmia, known suspected infection, hepatitis B or C or neoplasm) that, in the opinion of the investigator, would expose the subjects to undue risk of a significant adverse events (AE) or interfere with the assessment of safety or effectiveness during the trial
- History or evidence of alcohol or drug abuse within the past 12 months, or treatment for alcohol or drug abuse, or meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for any significant substance abuse disorder within the past 12 months prior to the Screening Visit
- Subjects should be excluded if they have a positive drug screen for drugs of abuse and are considered medically significant by the investigator, would compromise subject safety, or interfere with the interpretation of study results. In addi
Data sourced from ClinicalTrials.gov (NCT05371652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.