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Trial record 17 of 179 for:    Migraine AND migraine with or without aura

Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)

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ClinicalTrials.gov Identifier: NCT00432237
Recruitment Status : Completed
First Posted : February 7, 2007
Results First Posted : December 6, 2010
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: MK0974 50 mg Drug: MK0974 150 mg Drug: MK0974 300 mg Drug: Comparator: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1703 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK0974 in the Acute Treatment of Migraine With or Without Aura
Study Start Date : March 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: MK0974 50 mg
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
Drug: MK0974 50 mg
Other Name: MK0974

Experimental: MK0974 150 mg
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Drug: MK0974 150 mg
Other Name: MK0974

Experimental: MK0974 300 mg
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Drug: MK0974 300 mg
Other Name: MK0974

Placebo Comparator: Placebo
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Drug: Comparator: Placebo
MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.




Primary Outcome Measures :
  1. Number of Patients Reporting Pain Freedom at 2 Hours Postdose [ Time Frame: 2 hours post dose ]

    Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose.

    Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.


  2. Number of Patients Reporting Pain Relief at 2 Hours Post Dose [ Time Frame: 2 hours post dose ]

    Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose.

    Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.


  3. Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose [ Time Frame: 2 hours post dose ]
    Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.

  4. Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose [ Time Frame: 2 hours post dose ]
    Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.

  5. Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose [ Time Frame: 2 hours post dose ]
    Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.


Secondary Outcome Measures :
  1. Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose [ Time Frame: 2 to 24 hours postdose ]
    Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.

  2. Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose [ Time Frame: 2 to 24 hours postdose ]
    Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.

  3. Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose [ Time Frame: 2 hours postdose ]
    Pain Freedom and no migraine-associated symptoms at 2 hours postdose.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has at least 1 year history of migraine (with or without aura)
  • Females of childbearing years must use acceptable contraception throughout trial

Exclusion Criteria:

  • Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
  • Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
  • Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  • Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
  • Patient has a history of cancer within the last 5 years

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): NCT00432237


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

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00432237     History of Changes
Other Study ID Numbers: 0974-016
2006_526
First Posted: February 7, 2007    Key Record Dates
Results First Posted: December 6, 2010
Last Update Posted: July 3, 2015
Last Verified: June 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