| August 13, 2007 |
| July 7, 2009 |
| October 2007 |
| April 2008 (final data collection date for primary outcome measure) |
| Number of Participants Who Are Pain Free at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ] |
- Percentage of patients who are pain free [ Time Frame: 2 hours postdose ]
- Tolerability as measured by subjective adverse experience reporting
|
| Complete list of historical versions of study NCT00516737 on ClinicalTrials.gov Archive Site |
- Number of Participants With 24-Hour Sustained Pain Freedom [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
- Number of Participants With no Rescue Use up to 24 Hours Post-Dose [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
- Number of Participants With Absence of Photophobia at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
- Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
- Number of Participants With Absence of Nausea at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
- Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
|
| Percentage of patients with 24hr sustained pain freedom, associated symptoms, and use of rescue medication [ Time Frame: 24hr post dose ] |
| |
| Study to Test Rizatriptan in the Early Treatment of Acute Migraine |
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine |
The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Migraine |
- Drug: Comparator: rizatriptan benzoate
- Drug: Comparator: Placebo
|
- Experimental: Active Drug
- Placebo Comparator: Matching Pbo Comparator
|
| Cady RK, Martin VT, Géraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. |
| |
| Completed |
| 207 |
| April 2008 |
| April 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Greater than one year history of migraine
- Attacks typically mild when they begin and progress to moderate or severe
- Experience 1-4 migraine attacks per month
Exclusion Criteria:
- More than 15 headache days per month
- Heart disease
- Uncontrolled high blood pressure
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00516737 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2007_547, MK0462-081 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| July 2009 |
