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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00899379
First received: May 8, 2009
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Migraine Headache
Drug: rizatriptan benzoate
Drug: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Triple-Blind, Placebo-Controlled, Outpatient Study to Examine the Safety and Efficacy of MK462 10 mg p.o. in the Treatment of Multiple Attacks of Migraine Headache

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Pain Relief at 2 Hours During the First Migraine Attack Period [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Pain Relief at 2 Hours During the Second Migraine Attack Period [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack

  • Pain Relief at 2 Hours During the Third Migraine Attack Period [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack

  • Pain Relief at 2 Hours During the Fourth Migraine Attack Period [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack


Enrollment: 473
Study Start Date: April 1995
Study Completion Date: May 1996
Primary Completion Date: January 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence 1
Placebo-Rizatriptan-Rizatriptan-Rizatriptan
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Name: MK0462
Drug: Comparator: Placebo
Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 2
Rizatriptan-Placebo-Rizatriptan-Rizatriptan
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Name: MK0462
Drug: Comparator: Placebo
Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 3
Rizatriptan-Rizatriptan-Placebo-Rizatriptan
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Name: MK0462
Drug: Comparator: Placebo
Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 4
Rizatriptan-Rizatriptan-Rizatriptan-Placebo
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Name: MK0462
Drug: Comparator: Placebo
Placebo to Rizatriptan, Oral Tablet
Experimental: Treatment Sequence 5
Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan
Drug: rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
Other Name: MK0462

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899379

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00899379     History of Changes
Other Study ID Numbers: 0462-025, MK0462-025, 2009_590
Study First Received: May 8, 2009
Results First Received: September 26, 2009
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Benzoates
Rizatriptan
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014