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

NCT00516737 | Completed Phase 3 Results

• 2 other identifiers: 0462-0812007_547
• Study Type: interventional
• Target: 207
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of Participants With 24-Hour Sustained Pain Freedom

  24 hours post-dose

• Number of Participants With no Rescue Use up to 24 Hours Post-Dose

  24 hours post-dose

• Number of Participants With Absence of Photophobia at 2 Hours Post-dose

  2 hours post-dose

• Number of Participants With Absence of Phonophobia at 2 Hours Post-dose

  2 hours post-dose

• Number of Participants With Absence of Nausea at 2 Hours Post-dose

  2 hours post-dose

Study Arms (2)

1

EXPERIMENTAL

Active Drug

Drug: Comparator: rizatriptan benzoate

2

PLACEBO COMPARATOR

Matching Pbo Comparator

Drug: Comparator: Placebo

Interventions

Comparator: rizatriptan benzoate DRUG

Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack

Also known as: MK0462

1

Comparator: Placebo DRUG

Matching placebo; one dose, treatment of a single migraine attack

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• More than 15 headache days per month
• Heart disease
• Uncontrolled high blood pressure

Sponsors & Collaborators

• Organon and Co: lead

Related 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.

  PMID: 19472447 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

In the Adverse Events section, all non-serious adverse experiences reported are post-treatment, up to the time of taking rescue medication or 14 days post-dose, whichever comes first.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 15, 2007
• Study Start: October 3, 2007
• Primary Completion: April 8, 2008
• Study Completion: April 8, 2008
• Last Updated: April 22, 2024
• Results First Posted: April 14, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share