Trials / Completed
CompletedNCT01004263
A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)
A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 674 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
To provide long term safety data for rizatriptan in children and adolescents. The primary hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of acute migraine in pediatric patients age 12-17 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rizatriptan benzoate | Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2011-04-18
- Completion
- 2011-04-18
- First posted
- 2009-10-29
- Last updated
- 2024-04-22
- Results posted
- 2012-05-04
Source: ClinicalTrials.gov record NCT01004263. Inclusion in this directory is not an endorsement.