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Completed

NCT Number: NCT00897104

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

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.

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Key information

Conditions

Migraine Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rizatriptan benzoate (MK0462)

Drug

single dose 5 mg rizatriptan p.o.

Other names: MK0462

Comparator: Sumatriptan

Drug

single dose 50 mg sumatriptan p.o.

Comparator: placebo

Drug

Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
1995
Primary completion
1996
Study completion
1996
First posted
May 12, 2009
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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