A Randomized, Triple-Blind, Placebo-Controlled, Outpatient Study to Examine the Safety and Efficacy of MK462 10 mg p.o. in the Treatment of Multiple Attacks of Migraine Headache
Overview
- Phase
- Phase 3
- Intervention
- rizatriptan benzoate
- Conditions
- Migraine Headache
- Sponsor
- Organon and Co
- Enrollment
- 473
- Primary Endpoint
- Pain Relief at 2 Hours During the First Migraine Attack Period
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient had at least a 6-month history of migraine, with or without aura
- •Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
- •Patient was judged to be in good health, apart from migraine
Exclusion Criteria
- •Patient was pregnant or a nursing mother.
- •Patient had abused drugs or alcohol within 12 months prior to entering the study
- •Patient had a history of cardiovascular disease
- •Patient had clinically significant ECG abnormality
- •Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
- •Patient received treatment with an investigational device or compound within 30 days of the study start
- •Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
- •Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- •Patient had prior exposure to rizatriptan
Arms & Interventions
Treatment Sequence 1
Placebo-Rizatriptan-Rizatriptan-Rizatriptan
Intervention: rizatriptan benzoate
Treatment Sequence 2
Rizatriptan-Placebo-Rizatriptan-Rizatriptan
Intervention: rizatriptan benzoate
Treatment Sequence 3
Rizatriptan-Rizatriptan-Placebo-Rizatriptan
Intervention: rizatriptan benzoate
Treatment Sequence 4
Rizatriptan-Rizatriptan-Rizatriptan-Placebo
Intervention: rizatriptan benzoate
Treatment Sequence 5
Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan
Intervention: rizatriptan benzoate
Outcomes
Primary Outcomes
Pain Relief at 2 Hours During the First Migraine Attack Period
Time Frame: 2 hours
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack
Secondary Outcomes
- Pain Relief at 2 Hours During the Second Migraine Attack Period(2 hours)
- Pain Relief at 2 Hours During the Third Migraine Attack Period(2 hours)
- Pain Relief at 2 Hours During the Fourth Migraine Attack Period(2 hours)