A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, CrossoverStudy to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of AcuteMigraine in Patients With Stable Vascular Disease. - ND

• Conditions: Patients With Stable Vascular Disease and Acute Migraine Attacks; MedDRA version: 9.1Level: LLTClassification code 10027599Term: Migraine

• Registration Number: EUCTR2007-007723-40-IT
• Lead Sponsor: MERCK SHARP DOHME ITALIA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Patient is ≥18 years of age at screening.
2. Patient has a history of migraine headache with or without aura >1 year with ≥1 and
≤8 moderate or severe migraine headache attacks per month in the 2 months prior to
screening that typically last between 4 to 72 hours if left untreated (see Appendix 6.1
for IHS migraine definitions) [1].
3. Patient is either:
a) of reproductive potential and agrees to remain abstinent* or use (or have their
partner use) 2 acceptable methods of birth control within the projected duration of
the study. Acceptable methods of birth control are: hormonal contraceptive,
intrauterine device (IUD), diaphragm, spermicide, cervical cap, contraceptive
0974, Protocol 034-00 Issue Date: 19-Dec-2007 13
Product: MK-0974 7
Protocol/Amendment No.: 034-00
0974_034-00_ProtCore VERSION 5.0 APPROVED 19-Dec-2007
Worldwide Restricted Confidential Limited Access
sponge, condom, vasectomy. Complete details regarding contraceptive requirements
are specified in protocol Section 3.2.2.3.
OR
b) not of reproductive potential. The following definitions apply:
A female patient who is not of childbearing potential is defined as:
one who has either 1) reached natural menopause (defined as 6 months of
spontaneous amenorrhea with serum FSH levels in the postmenopausal range
as determined by the central laboratory, or 12 months of spontaneous
amenorrhea), 2) 6 weeks post surgical bilateral oophorectomy with or without
hysterectomy, 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 two
acceptable birth control methods must be used.
4. Patient is judged to be in satisfactory health in the opinion of the investigator based
on screening assessment including medical history, physical examination, ECGs and
laboratory testing.
5. Patient has clinical diagnosis of stable coronary artery disease (CAD) for ≥3 months
prior to Visit 1 (screening) as evidenced by any of following: angiogram, stress test,
history of myocardial infarction (MI) or other symptomatic and/or asymptomatic
(silent) myocardial ischemia, history of coronary artery bypass graft (CABG), or
percutaneous transluminal coronary angioplasty (PTCA).
NOTE: Patients with both migraine and stable CAD who also have a history of other
stable vascular disease (cerebral vascular disease or peripheral vascular disease)
present for ≥3 months prior to Visit 1 may be included (see Appendix 6.9).
6. Patient understands the study procedures, alternative treatments available, and risks
involved with the study, and voluntarily agrees to participate by giving written
informed consent.
7. 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:
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 β-hCG test at screening visit) 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 headache attacks from tension
headaches.
3. Patient has a history of predominantly mild migraine headache attacks or migraine
headaches that usually resolve spontaneously without treatment in less than 2 hours.
4. Patient has basilar or hemiplegic migraine headaches.
5. Patient has more than 15 headache-days (either migraine or other headaches) 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 cardiovascular or 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 headache onset.
8. Patient difficult to interpret (e.g., atrial fibrillation, clinically significant
ventricular arrhythmia, first degree or greater AV block, resting ST-segment
depression ≥1 mm in any lead, left/right bundle-branch block), or has a QTc interval
of ≥460 msec.
9. Patient has, within 3 months of screening, a class III or IV congestive heart failure,
ejection fraction <40%, unstable angina, myocardial infarction (MI), transient
ischemia (TIA), stroke, any coronary or non-coronary revascularization procedure
(e.g., percutaneous transluminal coronary angioplasty [PTCA], coronary artery
bypass graft [CABG], carotid stenting, or carotid endarterectomy).
10. Patient has a history of atrial fibrillation, clinically significant ventricular arrhythmia,
acute pulmonary edema, aneurysm, venous thromboembolic diseases, or valve
replacement, any implanted electrical device (e.g., pacemaker, defibrillator).
11. Patient has evidence of clinically significant uncontrolled hypertension (defined as
SBP of ≥160 mm Hg or DBP of ≥100 mm Hg), or a pulse rate >100 beats/minute.
Blood pressure and pulse measurements exceeding these limits may be repeated (at
the initial screening visit or at a second screening visit).
12. Patient exhibits bradycardia or heart rate extremes that preclude the patient y at

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 of MK-0974 compared to placebo in the treatment of acute<br>migraine in patients with stable vascular disease, as measured by pain freedom at<br>2 hours postdose.;Secondary Objective: 2. To evaluate the safety and tolerability of MK-0974 compared to<br>acetaminophen/paracetamol in the treatment of acute migraine in patients with stable<br>vascular disease.;Primary end point(s): The primary efficacy endpoint is the proportion of patients reporting pain freedom at<br>2 hours postdose after the 1st attack during the study period.