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Completed

NCT Number: NCT00898677

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

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.

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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

  • 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

Treatment and study plan

rizatriptan benzoate

Drug

single dose administration of 5mg rizatriptan (by Mouth) p.o.

Other names: rizatriptan, MK0462

Comparator: Sumatriptan

Drug

single dose administration of sumatriptan 100 p.o.

Other names: sumatriptan

Comparator: placebo

Drug

placebo to rizatriptan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

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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