Clinical Trials Register

Summary
EudraCT Number:	2007-007723-40
Sponsor's Protocol Code Number:	MK0974-034
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-10-13
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2007-007723-40

A.3

Full title of the trial

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover
Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute
Migraine in Patients With Stable Vascular Disease.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

MK0974-034

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	MERCK SHARP DOHME ITALIA S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	MK0974
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MK0974
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients With Stable Vascular Disease and Acute Migraine Attacks

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10027599
E.1.2	Term	Migraine

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1. To evaluate the efficacy of MK-0974 compared to placebo in the treatment of acute
migraine in patients with stable vascular disease, as measured by pain freedom at
2 hours postdose.

E.2.2

Secondary objectives of the trial

2. To evaluate the safety and tolerability of MK-0974 compared to
acetaminophen/paracetamol in the treatment of acute migraine in patients with stable
vascular disease.

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the proportion of patients reporting pain freedom at
2 hours postdose after the 1st attack during the study period.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	Yes
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-10-13.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	25
F.4.2	For a multinational trial
F.4.2.1	In the EEA	95
F.4.2.2	In the whole clinical trial	400

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2008-05-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-04-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-09-02

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