Acute Treatment of Migraine
Conditions
Keywords
Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent
Brief summary
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
Interventions
DRUGRimegepant (PF-07899801)
Rimegepant 75 mg, 50 mg or 35 mg ODT
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. History of migraine (with or without aura) for ≥ 6 months before Screening. 2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening. 3. 1 or more migraine days requiring treatment during the Observation Phase. 4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit. 5. Ability to distinguish between migraine and other types of headaches. 6. Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg. 7. Adequate venous access for blood sampling. 8. Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
Exclusion criteria
1. History of cluster headache or hemiplegic migraine headache. 2. Confounding and clinically significant pain syndrome. 3. Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded). 4. History of suicidal behavior or at risk of self-harm/harm to others. 5. History of major psychiatric disorder. 6. Current diagnosis or history of substance abuse 7. Reported current use of or tested positive at Screening for drugs of abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities | 58 weeks | To evaluate the safety and tolerability of rimegepant in children and adolescents (6 to \< 18 years of age). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation | 58 weeks | To evaluate the frequency and severity of hepatic-related adverse events and the frequency of hepatic-related treatment discontinuations in children and adolescents (6 to less than 18 years of age) treated with rimegepant. |
Countries
Poland, Spain, United States
Contacts
CONTACTPfizer Pfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed