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

• ClinicalTrials.gov Identifier: NCT00897949
• Recruitment Status: Completed
• First Posted: May 12, 2009
• Results First Posted: May 4, 2011
• Last Update Posted: February 3, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Migraine Headache	Drug: rizatriptan benzoate (MK0462); Drug: Comparator: placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1473 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Triple-Blind, Double-Dummy, Placebo-Controlled, Parallel Groups, Outpatient Study to Examine the Safety and Efficacy of MK0462 10 mg p.o. and MK0462 5 mg p.o. for the Treatment of Acute Migraine and Migraine Recurrence
• Study Start Date: March 1995
• Actual Primary Completion Date: January 1996
• Actual Study Completion Date: July 1996

Arms and Interventions

Arm	Intervention/treatment
Experimental: Rizatriptan 10 mg	Drug: rizatriptan benzoate (MK0462); Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.
Experimental: Rizatriptan 5 mg	Drug: rizatriptan benzoate (MK0462); Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.
Placebo Comparator: Placebo	Drug: Comparator: placebo; Placebo to rizatriptan

Outcome Measures

Primary Outcome Measures :

1. Pain Relief at 2 Hours After the Initial Dose of Test Drug [ Time Frame: 2 hours after 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.

Secondary Outcome Measures :

1. Pain Free at 2 Hours After the Initial Dose of Test Drug [ Time Frame: 2 hours after initial dose of test drug ]
   Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) 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. No Disability at 2 Hours After the Initial Dose of Test Drug [ Time Frame: 2 hours after initial dose of test drug ]
   Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 - Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest
3. Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug [ Time Frame: 2 hours after initial dose of test drug ]
4. Pain Relief 2 Hours After Treatment for Headache Recurrence [ Time Frame: 2 hours after treatment for recurrence ]
   Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Sponsors and Collaborators

Organon and Co

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

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.

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.

Other Publications:

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.

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.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00897949
• Other Study ID Numbers: 0462-022; 2009_589
• First Posted: May 12, 2009
• Results First Posted: May 4, 2011
• Last Update Posted: February 3, 2022
• Last Verified: February 2022

Additional relevant MeSH terms:

Migraine Disorders; Recurrence; Headache; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pain; Neurologic Manifestations; Rizatriptan; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs