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A Study of Gastric Delay in Migraine Patients (3207-003)

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK3207
Comparator: Placebo (unspecified)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-smoking male or female between 18 to 45 years of age
  • Patient typically has between 2 and 10 migraine attacks per month, rated as moderate or severe

Exclusion Criteria:

  • Patient has any other medical conditions other than migraine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    MK3207 Orally administered to patients with water. During each period (with and without acute migraine).

    MK3207 placebo as tablets will be Orally administered to patients with water. During each period (with and without acute migraine).

    Outcomes

    Primary Outcome Measures

    Safety in migraine patients

    Secondary Outcome Measures

    PK in migraine patients

    Full Information

    First Posted
    October 19, 2007
    Last Updated
    December 18, 2014
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00548353
    Brief Title
    A Study of Gastric Delay in Migraine Patients (3207-003)
    Official Title
    A Randomized, Double-Blind, Placebo Controlled, 2-Period, Fixed-Sequence Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Orally Administered MK3207 in Patients During and Between Their Acute Migraine Attacks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    A study to assess safety and PK of an investigational drug in migraine patients during and between migraine attacks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK3207 Orally administered to patients with water. During each period (with and without acute migraine).
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    MK3207 placebo as tablets will be Orally administered to patients with water. During each period (with and without acute migraine).
    Intervention Type
    Drug
    Intervention Name(s)
    MK3207
    Intervention Description
    M3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo (unspecified)
    Intervention Description
    M3207 (20 mg) Pbo; patients will be administered a single dose of 100 mg of MK3207 Pbo (i.e., 5 x20-mg tablets).
    Primary Outcome Measure Information:
    Title
    Safety in migraine patients
    Time Frame
    12 Weeks
    Secondary Outcome Measure Information:
    Title
    PK in migraine patients
    Time Frame
    12 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Non-smoking male or female between 18 to 45 years of age Patient typically has between 2 and 10 migraine attacks per month, rated as moderate or severe Exclusion Criteria: Patient has any other medical conditions other than migraine
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    A Study of Gastric Delay in Migraine Patients (3207-003)

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