Finding studies
Finding studies
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Pfizer CT.gov Call Center
CONTACT
Lead
Pfizer
The primary objective of this study is to evaluate the safety and tolerability of rimegepant 75 mg ODT. The primary endpoints are Incidence of Treatment-emergent adverse events (TEAEs) and Incidence of Serious adverse events (SAEs) This is a multicenter, single arm, open label phase IV study to evaluate the safety and tolerability of rimegepant 75 mg ODT for acute treatment of migraine with or without aura in adult migraine patients in India with a previous insufficient response to triptans, which includes: inadequate efficacy from treatment with triptans, intolerance to triptans, or contraindication(s) to triptans. Approximately 60 participants will be enrolled in the study. The participants who meet the inclusion exclusion criteria will be enrolled within 28 days of screening visit. The site staff will dispense the study medication ie, a single blister card containing one tablet of rimegepant 75 mg ODT to the participant to be taken for the treatment of subsequent migraine attack within 30 days of the baseline visit. Participants will be required to notify the site by a phone call in the event of a migraine attack and confirm whether the medication was taken. Participants will have a 12-hour window to contact the site following a migraine attack so that the call can be completed within the site's working hours. Following this, participants will receive a telephone call approximately 2 days after taking rimegepant 75 mg ODT, during which any AEs or SAEs will be evaluated. Participant satisfaction will be evaluated using TSQM-9 during post dose phone call. The participant will come for an EOS visit (28-35) days post-dose. Total duration of the study can go up to 93 days including, screening period = up to 28 days treatment window = up to 30 days follow up period = up to 35 days post dose (maximum total = 28 + 30 + 35 = up to 93 days)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
