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

NCT00899379 | Completed Phase 3 Results

• 3 other identifiers: 0462-025MK0462-0252009_590
• Study Type: interventional
• Target: 473
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (1)

• Pain Relief at 2 Hours During the First Migraine Attack Period

  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

  2 hours

Secondary Outcomes (3)

• 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

Study Arms (5)

Treatment Sequence 1

EXPERIMENTAL

Placebo-Rizatriptan-Rizatriptan-Rizatriptan

Drug: rizatriptan benzoate; Drug: Comparator: Placebo

Treatment Sequence 2

EXPERIMENTAL

Rizatriptan-Placebo-Rizatriptan-Rizatriptan

Drug: rizatriptan benzoate; Drug: Comparator: Placebo

Treatment Sequence 3

EXPERIMENTAL

Rizatriptan-Rizatriptan-Placebo-Rizatriptan

Drug: rizatriptan benzoate; Drug: Comparator: Placebo

Treatment Sequence 4

EXPERIMENTAL

Rizatriptan-Rizatriptan-Rizatriptan-Placebo

Drug: rizatriptan benzoate; Drug: Comparator: Placebo

Treatment Sequence 5

EXPERIMENTAL

Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan

Drug: rizatriptan benzoate

Interventions

rizatriptan benzoate DRUG

Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache

Also known as: MK0462

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5

Comparator: Placebo DRUG

Placebo to Rizatriptan, Oral Tablet

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (4)

• Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.

  PMID: 19222588 BACKGROUND

• Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3.

  PMID: 19210513 BACKGROUND

• Kramer MS, Matzura-Wolfe D, Polis A, Getson A, Amaraneni PG, Solbach MP, McHugh W, Feighner J, Silberstein S, Reines SA. A placebo-controlled crossover study of rizatriptan in the treatment of multiple migraine attacks. Rizatriptan Multiple Attack Study Group. Neurology. 1998 Sep;51(3):773-81. doi: 10.1212/wnl.51.3.773.

  PMID: 9748025 RESULT

• Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. doi: 10.1046/j.1526-4610.1998.3810764.x.

  PMID: 11284464 RESULT

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

Pooled Extension data for PN022- NCT00897949; PN025- NCT00899379 and PN029- NCT00897104 appears in NCT00897949

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: May 8, 2009
• First Posted: May 12, 2009
• Study Start: April 1, 1995
• Primary Completion: January 1, 1996
• Study Completion: April 1, 1996
• Last Updated: February 3, 2022
• Results First Posted: July 15, 2010

Record last verified: 2022-02