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: September 3, 2014
Last verified: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 3, 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
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014