MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00897104
First received: May 8, 2009
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.


Condition Intervention Phase
Migraine Headache
Drug: rizatriptan benzoate (MK0462)
Drug: Comparator: sumatriptan
Drug: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain Relief at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants 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

  • Time to Relief Within 2 Hours After Treatment [ Time Frame: within 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).


Secondary Outcome Measures:
  • Pain Free at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).

  • Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).

  • Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.

  • Participants Who Used Escape Medication 2 Hours After the Treatment Dose [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.

  • Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence


Enrollment: 933
Study Start Date: August 1995
Study Completion Date: September 1996
Primary Completion Date: May 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rizatriptan
Drug: rizatriptan benzoate (MK0462)
single dose 5 mg rizatriptan p.o.
Other Name: MK0462
Experimental: 2
Sumatriptan
Drug: Comparator: sumatriptan
single dose 50 mg sumatriptan p.o.
Placebo Comparator: 3
Placebo
Drug: Comparator: Placebo
Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant had at least a 6-month history of migraine, with or without aura
  • Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
  • Participant was judged to be in good health, apart from migraine

Exclusion Criteria:

  • Participant was Pregnant or a nursing mother
  • Participant had a history or current evidence of drug or alcohol abuse
  • Participant had a history or clinical evidence of cardiovascular disease
  • Participant had a clinically significant Electrocardiography (ECG) abnormality
  • Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
  • Participant had received treatment with an investigational device or compound within 30 days of the study
  • Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
  • Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
  • Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium
  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: NCT00897104

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00897104     History of Changes
Other Study ID Numbers: 0462-029, 2009_593
Study First Received: May 8, 2009
Results First Received: September 26, 2009
Last Updated: September 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 September 16, 2014