NCT00548353

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2007

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

October 19, 2007

Last Update Submit

December 18, 2014

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

  • Safety in migraine patients

    12 Weeks

Secondary Outcomes (1)

  • PK in migraine patients

    12 Weeks

Study Arms (2)

1

EXPERIMENTAL

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

Drug: MK3207

2

PLACEBO COMPARATOR

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

Drug: Comparator: Placebo (unspecified)

Interventions

MK3207DRUG

M3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).

1
Comparator: Placebo (unspecified)DRUG

M3207 (20 mg) Pbo; patients will be administered a single dose of 100 mg of MK3207 Pbo (i.e., 5 x20-mg tablets).

2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patient has any other medical conditions other than migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine Disorders

Interventions

2-(8-(3,5-difluorophenyl)-10-oxo-6,9-diazaspiro(4.5)dec-9-yl)-N-(2'-oxo-1,1',2',3-tetrahydrospiro(indene-2,3'-pyrrolo(2,3-b)pyridin)-5-yl)acetamide

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 23, 2007

Study Start

August 1, 2007

Primary Completion

April 1, 2008

Study Completion

February 1, 2010

Last Updated

December 19, 2014

Record last verified: 2014-12