MK0462 in Treatment of Migraine With Recurrence (MK0462-022)

NCT00897949 | Completed Phase 3 Results

• 2 other identifiers: 0462-0222009_589
• Study Type: interventional
• Target: 1,473
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo. The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (1)

• Pain Relief at 2 Hours After the Initial Dose of Test Drug

  Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.

  2 hours after initial dose of test drug

Secondary Outcomes (4)

• Pain Free at 2 Hours After the Initial Dose of Test Drug

  2 hours after initial dose of test drug

• No Disability at 2 Hours After the Initial Dose of Test Drug

  2 hours after initial dose of test drug

• Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug

  2 hours after initial dose of test drug

• Pain Relief 2 Hours After Treatment for Headache Recurrence

  2 hours after treatment for recurrence

Study Arms (3)

Rizatriptan 10 mg

EXPERIMENTAL

Drug: rizatriptan benzoate (MK0462)

Rizatriptan 5 mg

EXPERIMENTAL

Drug: rizatriptan benzoate (MK0462)

Placebo

PLACEBO COMPARATOR

Drug: Comparator: placebo

Interventions

rizatriptan benzoate (MK0462) DRUG

Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.

Rizatriptan 10 mg; Rizatriptan 5 mg

Comparator: placebo DRUG

Placebo to rizatriptan

Placebo

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

• Teall J, Tuchman M, Cutler N, Gross M, Willoughby E, Smith B, Jiang K, Reines S, Block G. Rizatriptan (MAXALT) for the acute treatment of migraine and migraine recurrence. A placebo-controlled, outpatient study. Rizatriptan 022 Study Group. Headache. 1998 Apr;38(4):281-7. doi: 10.1046/j.1526-4610.1998.3804281.x.

  PMID: 9595867 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 NCT01286207

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: March 1, 1995
• Primary Completion: January 1, 1996
• Study Completion: July 1, 1996
• Last Updated: February 3, 2022
• Results First Posted: May 4, 2011

Record last verified: 2022-02