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

Migraine Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516737
• Other study ID #: 0462-081
• Secondary ID: 2007_547
• Status: Completed
• Phase: Phase 3
• Start date: October 3, 2007
• Est. completion date: April 8, 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: April 8, 2008
• Est. primary completion date: April 8, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Comparator: rizatriptan benzoate
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
• Comparator: Placebo
Matching placebo; one dose, treatment of a single migraine attack

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Are Pain Free at 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.	2 hours post-dose
Secondary	Number of Participants With 24-Hour Sustained Pain Freedom	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.	24 hours post-dose
Secondary	Number of Participants With no Rescue Use up to 24 Hours Post-Dose	Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.	24 hours post-dose
Secondary	Number of Participants With Absence of Photophobia at 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.	2 hours post-dose
Secondary	Number of Participants With Absence of Phonophobia at 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.	2 hours post-dose
Secondary	Number of Participants With Absence of Nausea at 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.	2 hours post-dose
Secondary	Number of Participants With Absence of Functional Disability at 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.	2 hours post-dose