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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00548353
Enrollment
22
Registered
2007-10-23
Start date
2007-08-31
Completion date
2010-02-28
Last updated
2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Brief summary

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

Interventions

DRUGMK3207

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

DRUGComparator: Placebo (unspecified)

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

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety in migraine patients12 Weeks

Secondary

MeasureTime frame
PK in migraine patients12 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026