Treatment of Multiple Attacks of Acute Migraine (0462-025)

Phase 3

Completed

• Conditions: Migraine Headache
• Interventions: Drug: rizatriptan benzoate

• Registration Number: NCT00899379
• Lead Sponsor: Organon and Co

Brief Summary

A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-04
• Primary Completion: 1996-01
• Study Completion: 1996-04
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-08
• Study First Posted: 2009-05-12
• Results First Submitted: 2009-09-26
• Results First Submitted QC: 2010-06-14
• Results First Posted: 2010-07-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 473

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 2	rizatriptan benzoate	Rizatriptan-Placebo-Rizatriptan-Rizatriptan
Treatment Sequence 5	rizatriptan benzoate	Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan
Treatment Sequence 1	rizatriptan benzoate	Placebo-Rizatriptan-Rizatriptan-Rizatriptan
Treatment Sequence 3	rizatriptan benzoate	Rizatriptan-Rizatriptan-Placebo-Rizatriptan
Treatment Sequence 4	rizatriptan benzoate	Rizatriptan-Rizatriptan-Rizatriptan-Placebo

Primary Outcome Measures

Name	Time	Method
Pain Relief at 2 Hours During the First Migraine Attack Period	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 Outcome Measures

Name	Time	Method
Pain Relief at 2 Hours During the Second Migraine Attack Period	2 hours	Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack
Pain Relief at 2 Hours During the Third Migraine Attack Period	2 hours	Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack
Pain Relief at 2 Hours During the Fourth Migraine Attack Period	2 hours	Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack