| Croop et al. (2019)[@147936] |
1,466 participants aged 18 or older with a history of migraines for at least 1 year were randomly assigned to the 75 mg rimegepant or placebo groups. A total of 682 participants received rimegepant and 693 received placebo. Rimegepant was delivered in the form of an orally disintegrating tablet (ODT). |
Rimegepant ODT provided patients with superior freedom from pain (21% vs 11%, p<0.0001; risk
difference 10, 95% CI 6-14) and freedom from most bothersome symptom (35% vs 27%, p=0.0009,
risk difference 8, 95% CI 3-13) at 2 hours post dose compared with placebo. The following were the most common adverse events: nausea (rimegepant n=11 [2%]; placebo n=3 [<1%]), urinary tract infection (rimegepant n=10 [1%]; placebo n=4 [1%]). In both the rimegepant and placebo groups, one participant in each group had a transaminase level that was more than 3x the upper limit of normal; however neither was found to be related to the medications given in
the study. |
A single dose of 75 mg rimegepant ODT provided superior symptom control than placebo with similar safety. |
| Lipton et al. (2019)[@147941] |
1,186 patients with at least a 1 year history of migraines were randomly assigned to receive 75 mg rimegepant or placebo. Overall 537 patients receiving rimegepant and 535 patients receiving placebo were evaluated. The primary outcome was freedom from pain, defined as absence of pain in a person who had previous moderate or severe pain before dose administration. The secondary outcome was freedom from most bothersome associated migraine symptom, including photophobia, phonophobia, or nausea. |
A modified intention-to-treat analysis found that 19.6% of patients who received rimegepant were pain- free after 2 hours of the dose versus 12.0% of those who received the placebo (95% CI, 3.3 to 11.9; P<0.001). 37.6% of patients in the rimegepant group were free of their most bothersome symptom 2 hours after the dose and 25.3% of patients in the placebo group (95% CI, 6.9 to 17.9; P<0.001). Nausea and urinary tract infection were the most common adverse effects. |
Treatment with rimegepant provided patients with increased freedom from pain and their most bothersome symptom than did placebo. |
| Gao et al. (2019)[@147942] |
A systematic review of Pubmed, Embase, and Cochrane between January 2001 and August 2019 using keywords “rimegepant; migraine; BMS-927711; BHV-3000” was conducted. A meta-analysis of four RCTs identified in the review was performed including 3,827 patients total, was performed. Each RCT involved randomization of patients to either 75 mg rimegepant or placebo. |
Across all four RCTs, 75 mg rimegepant provided significantly greater freedom from pain (P
<0.001), pain relief (P <0.001), and freedom from most bothersome symptom (P <0.001) at 2 hours post dose versus placebo. Instances of adverse events were comparable in both groups. |
75 mg rimegepant is safe and effective for acute treatment of migraines. |
| (2022)[@147947] |
Sixty patients diagnosed with treatment- refractory trigeminal neuralgia were randomly assigned to receive 75 mg rimegepant then placebo or vice versa in this crossover study. The outcomes were measured using the Numeric Pain Rating Scale, a four-point likert scale from 0=none to 3=severe. Changes in symptomatic pain relief were measured as a daily rating of their worst pain episode based on an 11 point numeric rating scale. |
The outcomes being studied are safety and tolerability of rimegepant, efficacy for improving physical function and global functioning, improving functional disability, and providing symptomatic pain relief based on daily worst episode of pain. |
N/A |
| (2021)[@147946] |
1629 patients with at least a 1 year history of migraine were randomly assigned to receive 75 mg rimegepant or 75 mg matching placebo. |
The main outcome of interest is change from baseline in the mean number of days per month in the last four weeks with migraine.
Additional outcomes being evaluated include achievement of at least 50% reduction in mean number of monthly moderate to severe migraines and migraine days per month during the treatment phase of the trial. The following are also outcomes of interest: change in number of migraine days per month for first month of treatment phase, adverse events, frequency of AST or ALT elevations and hepatic-related adverse events, and mean change in Migraine-Specific Quality of Life Questionnaire (MSQ) role function
and Migraine Disability Assessment (MIDAS) total score. |
N/A |
| (2021)[@147945] |
1485 participants with at least 1 year history of migraines were assigned to receive either 75 mg rimegepant or placebo. Outcomes were measured by presence or absence of most bothersome symptom (MBS), a 4 point Likert scale of pain, functional disability score and a 4 point numeric rating scale (none, mild, moderate, severe) for sustained pain relief and/or pain relapse. |
Primary outcome measures include pain freedom and freedom from MBS at 2 hours post dose with rimegepant versus placebo.
Secondary outcomes assess the following measures in rimegepant versus placebo groups: number of subjects in each group that do not experience any headache pain from 2 to 24 hours post dose, differences in presence of photophobia and phonophobia, pain relief, freedom from nausea, requirement for rescue medication, sustained pain freedom and relief, proportion of patients able to return to normal function at 2 hours post dose, and pain relapse
scores. |
N/A |