A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00894556
First received: May 5, 2009
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.


Condition Intervention Phase
Acute Migraine
Drug: rizatriptan
Drug: Comparator: Placebo
Drug: Comparator: Sumatriptan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain Relief (PR) [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.


Secondary Outcome Measures:
  • Pain Freedom (PF) [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.


Enrollment: 109
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence A
Rizatriptan - Rizatriptan - Placebo
Drug: rizatriptan
Single dose of 10 mg orally disintegrating tablet at onset of migraine attack
Drug: Comparator: Placebo
Placebo to Rizatriptan
Experimental: Treatment Sequence B
Rizatriptan - Placebo - Rizatriptan
Drug: rizatriptan
Single dose of 10 mg orally disintegrating tablet at onset of migraine attack
Drug: Comparator: Placebo
Placebo to Rizatriptan
Experimental: Treatment Sequence C
Placebo - Rizatriptan - Rizatriptan
Drug: rizatriptan
Single dose of 10 mg orally disintegrating tablet at onset of migraine attack
Drug: Comparator: Placebo
Placebo to Rizatriptan
Baseline Phase
Sumatriptan
Drug: Comparator: Sumatriptan
single dose of generic sumatriptan 100 mg at onset of migraine attack

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
  • Patient generally does not respond to treatment with sumatriptan
  • Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
  • Patient is able to complete paper diary

Exclusion Criteria:

  • Patient is pregnant or breast feeding or excepts to become pregnant during the study
  • Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
  • Patient has basilar or hemiplegic migraines
  • Patient is unable to distinguish between migraine attacks from other types of headaches
  • Patient has more than 15 headache-days per month
  • Patient was greater than 50 years old at age of migraine onset
  • Patient has failed to respond to 3 or more triptans
  • Patient has a repeated history of failing to respond to or tolerate rizatriptan
  • Patient uses opioids as primary migraine therapy
  • Patient uses daily opioids
  • Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
  • Patient has uncontrolled hypertension
  • Patient has a history of neoplastic disease
  • Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
  • Patient has a history of drug or alcohol abuse
  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: NCT00894556

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: NCT00894556     History of Changes
Other Study ID Numbers: 0462-087, 2009_587
Study First Received: May 5, 2009
Results First Received: September 23, 2010
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Treatment of acute migraine with or without aura in adults

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Rizatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014