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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT01001234 |
Purpose
This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine, Acute |
Drug: rizatriptan Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents |
| Estimated Enrollment: | 1240 |
| Study Start Date: | December 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Stage 1: 5mg rizatriptan |
Drug: rizatriptan
5 or 10mg rizatriptan orally disintegrating tablet (ODT) administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after interactive voice response system (IVRS) just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
Other Name: MK-0462
|
| Experimental: Stage 1: 10mg rizatriptan |
Drug: rizatriptan
5 or 10mg rizatriptan orally disintegrating tablet (ODT) administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after interactive voice response system (IVRS) just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
Other Name: MK-0462
|
| Placebo Comparator: Stage 1: placebo |
Drug: Placebo
Matching placebo ODT tablet administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after IVRS just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
|
| Experimental: Stage 2: 5mg rizatriptan |
Drug: rizatriptan
5 or 10mg rizatriptan orally disintegrating tablet (ODT) administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after interactive voice response system (IVRS) just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
Other Name: MK-0462
|
| Experimental: Stage 2: 10mg rizatriptan |
Drug: rizatriptan
5 or 10mg rizatriptan orally disintegrating tablet (ODT) administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after interactive voice response system (IVRS) just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
Other Name: MK-0462
|
| Placebo Comparator: Stage 2: placebo |
Drug: Placebo
Matching placebo ODT tablet administered within 30 minutes following the onset of a qualifying migraine (Stage 1) or administered immediately after IVRS just after the 15-minute post dose response for Stage 1 confirmation (Stage 2)
|
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT01001234 History of Changes |
| Other Study ID Numbers: | 2009_679, MK-0462-082 |
| Study First Received: | October 23, 2009 |
| Last Updated: | May 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Rizatriptan |
Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |