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Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00898677
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : July 14, 2009
Last Update Posted : March 4, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: rizatriptan benzoate Drug: Comparator: sumatriptan Drug: Comparator: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine
Study Start Date : September 1995
Actual Primary Completion Date : May 1996
Actual Study Completion Date : September 1996

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: 1
rizatriptan 5 mg
Drug: rizatriptan benzoate
single dose administration of 5mg rizatriptan (by Mouth) p.o.
Other Names:
  • rizatriptan
  • MK0462

Experimental: 2
rizatriptan 10 mg
Drug: rizatriptan benzoate
single dose administration of 10 mg rizatriptan p.o.
Other Names:
  • rizatriptan
  • MK0462

Active Comparator: 3
sumatriptan 100 mg
Drug: Comparator: sumatriptan
single dose administration of sumatriptan 100 p.o.
Other Name: sumatriptan

Placebo Comparator: 4
Drug: Comparator: Placebo
placebo to rizatriptan

Primary Outcome Measures :
  1. Pain Relief at 2 Hours After Dose [ Time Frame: 2 hours after dose ]
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment

  2. Time to Relief Within 2 Hours After Dose [ Time Frame: within 2 hours after dose ]
    Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose

Secondary Outcome Measures :
  1. Pain Free at 2 Hours After Dose [ Time Frame: 2 hours after dose ]
    Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).

  2. Functional Status at 2 Hours After Dose [ Time Frame: 2 hours after dose ]
    Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).

  3. Nausea at 2 Hours After Dose [ Time Frame: 2 hours after dose ]
    Patients who recorded the presence or absence of nausea 2 hours after dose

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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 Electrocardiography (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 hypersensitivity to sumatriptan
  • Patient had participated in any previous study involving rizatriptan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00898677

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Publications of Results:
Other Publications:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00898677    
Other Study ID Numbers: 0462-030
First Posted: May 12, 2009    Key Record Dates
Results First Posted: July 14, 2009
Last Update Posted: March 4, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs