Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Studyto Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the AcuteTreatment of Migraine With or Without Aura.

• Conditions: Patient has had a history of migraine with or without aura > 1 year with ≥ 1 and ≤ 8 moderate or severe migraine attacks per month in the 2 months prior to screening that typically last between 4 to 72 hours untreated; MedDRA version: 14.1Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2007-002667-28-IT
• Lead Sponsor: MERCK & CO., INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-22
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

1. Patient is ≥18 years of age at screening.
2. Patient has had a history of migraine with or without aura > 1 year with ≥ 1 and ≤ 8
moderate or severe migraine attacks per month in the 2 months prior to screening that
typically last between 4 to 72 hours untreated (see Appendix 6.1 and ICHD II
Attachment for IHS migraine definitions).
3. Patient is either:
a. of reproductive potential and agrees to maintain true abstinence* or use (or have
their partner use) one of the listed highly effective methods of birth control within
the projected duration of the study: hormonal contraceptives, intrauterine device
0974, Protocol 031-00 Issue Date: 10-Mar-2008 15
Product: MK-0974 7
Protocol/Amendment No.: 031-00
0974_031-00_ProtCore VERSION 6.0 APPROVED 10-Mar-2008
Worldwide Restricted Confidential Limited Access
(IUD), condoms, diaphragm, cervical cap, vasectomy. The use of barrier
contraceptive (condom, diaphragm, or cervical cap) should always be
supplemented with the use of a spermicide. Complete details regarding
contraceptive requirements are specified in protocol Section 3.2.3.2.
OR
b. not of reproductive potential. The following definitions apply:
A female patient who is not of reproductive potential is defined as:
one who has either 1) reached natural menopause (defined as age 46 or older
with a) 12 months spontaneous amenorrhea or b) 6 months of spontaneous
amenorrhea with serum FSH levels in the postmenopausal range as
determined by the central laboratory), 2) 6 weeks post surgical bilateral
oophorectomy 3) hysterectomy, or 4) bilateral tubal ligation.
A male patient who is not of reproductive potential is defined as:
one who has undergone a successful vasectomy. A successful vasectomy is
defined as: 1) microscopic documentation of azoospermia, or 2) a vasectomy
more than 2 years ago with no resultant pregnancy despite sexual activity post
vasectomy.
* If abstinence is not a locally acceptable method of contraception, then another highly
effective birth control method must be used.
4. Patient understands the study procedures, alternative treatments available, and risks
involved with the study, and voluntarily agrees to participate by giving written
informed consent.
5. Patient is able to complete the study questionnaire(s) and paper diary.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient is pregnant (positive serum pregnancy test at pre-study) or breast-feeding, or
is a female expecting to conceive within the projected duration of the study.
2. Patient has difficulty distinguishing his/her migraine attacks from tension headaches.
3. Patient has a history of predominantly mild migraine attacks or migraines that usually
resolve spontaneously in less than 2 hours.
4. Patient has basilar or hemiplegic migraine headache.
0974, Protocol 031-00 Issue Date: 10-Mar-2008 16
Product: MK-0974 8
Protocol/Amendment No.: 031-00
0974_031-00_ProtCore VERSION 6.0 APPROVED 10-Mar-2008
Worldwide Restricted Confidential Limited Access
5. Patient has more than 15 headache-days per month or has taken medication for acute
headache on more than 10 days per month in any of the 3 months prior to screening.
6. Patient is taking migraine prophylactic medication where the prescribed daily dose
has changed during the 3 months prior to screening.
7. Patient was > 50 years old at age of migraine onset.
8. Patient has clinical, laboratory, or ECG evidence of uncontrolled hypertension
(defined as SBP of ≥150 mm Hg and/or DBP of ≥95 mm Hg), uncontrolled diabetes,
HIV disease, or significant pulmonary,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) To evaluate the efficacy and safety of MK-0974 compared to placebo in the treatment<br>of acute migraine.<br>2) To evaluate the safety and the consistency of efficacy of MK-0974 across multiple<br>migraine attacks.;Secondary Objective: 1) To evaluate the efficacy of MK-0974 (280 mg and 140 mg) compared to placebo in<br>the treatment of acute migraine, as measured using sustained pain freedom from 2-24 hours and 2-48 hours post-dose and total migraine freedom at 2 hours and from 2-24 hours postdose (first attack only).;Primary end point(s): 2-hour pain<br>relief, pain freedom, and associated symptoms (photophobia, phonophobia, and nausea)