Research question and objectives Primary endpoint
• To evaluate the effectiveness of Rimegepant in the acute treatment of migraine as
measured by most severe pain, onset of pain relief, satisfaction with pain relief, and
satisfaction with return to normal function post-dose.
Secondary Objectives
To evaluate the effectiveness of Rimegepant in the acute treatment of migraine as
measured by onset of associated symptoms relief.
To evaluate the long-term effect of Rimegepant treatment on the treatment
satisfaction and global impression of change at months 3，6 and 12.
Exploratory Objective
To evaluate the long-term effectiveness of Rimegepant by evaluating the changes from
baseline in any decrease in MMD with any intensity in those participants with
baseline MMD ≥6 days.
To evaluate the long-term effectiveness of Rimegepant by evaluating the changes from
baseline of any decrease of MHD.
To evaluate the long-term effectiveness of Rimegepant by evaluating any decrease of
mean number of moderate to severe migraine days per month in those participants with
baseline MMD ≥6 days
To evaluate the changes from baseline in the percentage of MOH and chronic migraine
transformation to episodic migraine during Rimegepant long-term (PRN) use.
To evaluate the changes from baseline of Rimegepant usage, other migraine-related
medication usage and MO during Rimegepant long-term (PRN) use.
To evaluate the changes from baseline on quality of life, function, depression and
anxiety at months 3, 6 and 12.
To evaluate the association between the timing of Rimegepant dosing (dosing at pain
free while with any prodrome symptoms/ dosing at pain free while with any aura
symptoms / dosing at mild pain/ dosing at moderate pain/ dosing at severe pain) and
the acute treatment effectiveness of Rimegepant.
To evaluate the acute treatment effectiveness of Rimegepant in migraine participants
with a history of insufficient response or intolerable to NSAIDs /Triptans
/Combination analgesic.
To evaluate the acute treatment effectiveness of combination use of Rimegepant plus
NSAIDs/Triptans/Combination analgesic in participants with insufficient response to
monotherapy.
To evaluate the acute treatment effectiveness of Rimegepant in migraine participants
with prior treatment failure of more than two triptans.
Study design This is a single arm, prospective, multi-center, observational registry
study with participants receiving Rimegepant for the acute treatment of migraine in a
real-world setting. Each participant will receive treatment and care according to
standard clinical practice.
About 3,000 adult migraine participants will be enrolled continuously at 70 to 73 sites
with a headache clinic or headache center in China in approximately 16 consecutive months
or until reaching the target sample size.. The index date for a participant will be the
date of enrollment. The maximum follow-up period per participant after enrollment is 12
months.
At the Baseline Visit, the demographics information, socioeconomic characteristics, and
medical and migraine history will be collected from the enrolled participants. For the
acute treatment effectiveness evaluation, data on Rimegepant treating single migraine
attack including the timing of dosing, most severe pain, onset time of pain relief, onset
time of associated symptoms relief, satisfaction with pain relief and satisfaction with
function improvement are expected to be captured within 3 months after enrollment through
a digital platform. If none of these data are captured within 3 months, the participant
will be marked as failed in the study and will not be followed up further. For the
long-term effectiveness evaluation, participants will use an eDiary to record headache
and migraine occurrence, and use a digital platform to collect Rimegepant and other
migraine-related medication usage days every month. At study visits, participants will
complete the Migraine-Specific Quality-of-Life Questionnaire (MSQ) v2.1, Migraine
Disability Assessment (MIDAS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety
Disorder -7 (GAD-7), Patient Global Impression of Change (PGI-C) and the Satisfaction
with Medication (SM) scale at months 3, 6 and 12 via electronic patient reported outcomes
(ePROs). The previous four scales will be completed by participants at baseline visit.
