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Clinical Trials/EUCTR2007-007723-40-IT
EUCTR2007-007723-40-ITActive, not recruitingNot Applicable

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

MERCK SHARP DOHME ITALIA S.P.A.0 sites400 target enrollmentStarted: October 13, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
400
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.
  • •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
  • •* 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
  • +1 more not shown

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
  • •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

Investigators

Sponsor
MERCK SHARP DOHME ITALIA S.P.A.

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