Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

Phase 3

Completed

• Conditions: Migraine

• Registration Number: NCT00516737
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-15
• Study Start: 2007-10-03
• Primary Completion: 2008-04-08
• Study Completion: 2008-04-08
• Results First Submitted: 2009-03-12
• Results First Submitted QC: 2009-03-12
• Results First Posted: 2009-04-14
• Status Verified: 2022-02
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Are Pain Free at 2 Hours Post-Dose	2 hours post-dose	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Absence of Nausea at 2 Hours Post-dose	2 hours post-dose	Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.
Number of Participants With Absence of Phonophobia at 2 Hours Post-dose	2 hours post-dose	Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose	2 hours post-dose	Level of functional disability was assessed on a paper diary by the participants.; Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.
Number of Participants With 24-Hour Sustained Pain Freedom	24 hours post-dose	24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.
Number of Participants With no Rescue Use up to 24 Hours Post-Dose	24 hours post-dose	Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
Number of Participants With Absence of Photophobia at 2 Hours Post-dose	2 hours post-dose	Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.