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

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ClinicalTrials.gov Identifier: NCT00897104
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : July 23, 2010
Last Update Posted : February 3, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Headache Drug: rizatriptan benzoate (MK0462) Drug: Comparator: sumatriptan Drug: Comparator: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 933 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 Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine
Study Start Date : August 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

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Pain Relief at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ]
    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

  2. Time to Relief Within 2 Hours After Treatment [ Time Frame: within 2 hours after treatment ]
    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 :
  1. Pain Free at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ]
    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).

  2. 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 ]
    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).

  3. Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ]
    Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.

  4. Participants Who Used Escape Medication 2 Hours After the Treatment Dose [ Time Frame: 2 hours after treatment ]
    Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.

  5. Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) [ Time Frame: 24 hours ]
    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


Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00897104


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00897104    
Other Study ID Numbers: 0462-029
2009_593
First Posted: May 12, 2009    Key Record Dates
Results First Posted: July 23, 2010
Last Update Posted: February 3, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
 Sumatriptan
Rizatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs