Phase 3
N=1,935
Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
Migraines
Bottom Line
View on ClinicalTrials.gov: NCT00483704 ↗Enrolled (actual)
1,935
Serious AEs
1.2%
Results posted
Aug 2014
Primary outcome: Primary: Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) — 21.9; 25.1; 10.2 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Telcagepant 140 mg (Drug); Talcagepant 280 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) |
21.9; 25.1; 10.2 | <0.001 sig |
| PRIMARY Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) |
58.6; 56.7; 33.4 | <0.001 sig |
| PRIMARY Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose |
9.3; 14.1; 2.7 | <0.001 sig |
| PRIMARY Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose |
41.8; 46.8; 22.3 | <0.001 sig |
| PRIMARY Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack) |
52.3; 52.4; 40.6 | <0.001 sig |
| PRIMARY Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack) |
61.4; 59.4; 48.6 | <0.001 sig |
| PRIMARY Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack) |
72.9; 71.7; 62.8 | <0.001 sig |
| PRIMARY Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack) |
179; 167; 157 | — |
| PRIMARY Number of Participants Discontinuing Study Medication Due to an AE |
3; 5; 4 | — |
| SECONDARY Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) |
15.6; 19.1; 6.5 | <0.001 sig |
| SECONDARY Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack) |
13.4; 17.9; 6.2 | <0.001 sig |
| SECONDARY Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack) |
19.4; 22.3; 9.5 | <0.001 sig |
| SECONDARY Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) |
13.7; 17.1; 6.5 | <0.001 sig |
Summary
The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.
Eligibility Criteria
Inclusion Criteria
- History of migraines within the past year
- 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
- Use acceptable contraception throughout the study
- Able to complete the study questionnaire(s) and paper diary
- Limit consumption of grapefruit juice to no more than one 8 ounce glass a day
Exclusion Criteria
- Pregnant or breast-feeding or is expecting to become pregnant during the study
- Difficulty distinguishing his/her migraine attacks from tension or interval headaches
- A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
- More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
- Greater than 50 years old at the age of migraine onset
- Previously taken telcagepant
Data sourced from ClinicalTrials.gov (NCT00483704). 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.