Clinical Trials Register

Summary
EudraCT Number:	2011-002348-28
Sponsor's Protocol Code Number:	0462-083
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2011-06-30
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2011-002348-28

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Single-Dose Pharmacokinetics of MK-0462 in Migraineurs Aged 6 to 17 Years

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Assessment of Safety and Single-Dose Pharmacokinetics in Children

A.3.2

Name or abbreviated title of the trial where available

No Abbreviated Title Available

A.4.1

Sponsor's protocol code number

0462-083

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/27/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck & Co., Inc.
B.1.3.4	Country	United States
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	Merck & Co., Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck & Co., Inc.
B.5.2	Functional name of contact point	Iain Fraser, M.D.
B.5.3	Address:
B.5.3.1	Street Address	P.O. Box 100, One Merck Drive
B.5.3.2	Town/ city	Whitehouse Station, NJ
B.5.3.3	Post code	08889-0100
B.5.3.4	Country	United States
B.5.4	Telephone number	732594-3931
B.5.5	Fax number	732594-5405
B.5.6	E-mail	iain_fraser@merck.com

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	Yes
D.2.1.1.1	Trade name	MAXALT-MLT
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck & Co., Inc.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.1	Product name	rizatriptan benzoate
D.3.2	Product code	MK-0462
D.3.4	Pharmaceutical form	Dispersible tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	145202-66-0
D.3.9.2	Current sponsor code	0462
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	145202-66-0
D.3.9.2	Current sponsor code	0462
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	10
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Dispersible tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Migraine

E.1.1.1

Medical condition in easily understood language

Migraine Headaches

E.1.1.2

Therapeutic area

Body processes [G] - Bones and nerves physological processes [G11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10027599
E.1.2	Term	Migraine
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the safety and tolerability of single doses of rizatriptan ODT in pediatric migraineurs ages 6 - 17 years. To obtain preliminary plasma pharmacokinetic data (e.g., AUC, Cmax, Tmax, and terminal t1/2), following single dose administration of rizatriptan ODT in pediatric migraineurs ages 6 - 17 years.

E.2.2

Secondary objectives of the trial

To estimate preliminary plasma pharmacokinetic data following single dose administration of rizatriptan in migraineurs ages 6 - 17 years, and to compare with that obtained historically in adults.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. For Panels A and B, the patient is a male or female between the ages of 6 and 17 years. For Panel C, the patient is a male between the ages of 12 and 17 years.
2. Patient has a history of migraine headaches (as defined by the Headache Classification Subcommittee of the International Headache Society [2], and is not experiencing a migraine on the day of study drug administration.
3. Consent:
The parent or guardian and patient agrees to the patient’s participation in the study as indicated by parental/guardian signature on the consent form and patient assent. Written assent will be sought from subjects of appropriate intellectual maturity. The patient is willing to comply with procedures, and is able to keep scheduled clinic visits.
4. Patient has a history of migraine (for at least 6 months), but is judged to be otherwise in good health on the basis of medical history and physical examination.
5. Subject is a nonsmoker.
6. If female, subject is not pregnant and not breastfeeding.
7. If female and sexually active, the subject agrees to use a nonhormonal double-barrier birth control device or oral contraception from at least 1 month prior to the start of the study until at least 1 month after the completion of the study.
8. Subject weighs at least 20 kg.

E.4

Principal exclusion criteria

1. Subject has no history of migraine headaches, or is experiencing a migraine headache on the day of study drug administration.
2. Subject is <5th percentile or >95th percentile for age-appropriate Body Mass Index (see Section 7 Attachments for age-appropriate BMI charts).
3. If female, subject is, pregnant or nursing, or is sexually active but not willing to use effective barrier or appropriate oral contraception during the study.
4. Subject, or parent/legal guardian, is, in the opinion of the investigator, mentally incapacitated.
5. Subject has a history of asthma or other pulmonary disease, major gastrointestinal abnormalities/peptic ulceration, or cardiovascular, hepatic, neurologic, or renal disease.
6. Subject has a history of Kawasaki’s disease.
7. Subject has a history of phenylketonuria.
8. Subject has a history of hemiplegic or basilar migraine.
9. Subject has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering rizatriptan to the subject.
10. Subject has donated a unit of blood, or has participated in another clinical trial with an investigational agent within the 4 weeks prior to study start.
11. Subject drinks excessive amounts of caffeinated coffee or caffeinated beverages (>6 cups/day) at the time of the study.
12. Subject has clinically significant abnormalities on prestudy clinical examination or laboratory measurements, carried out approximately 1 to 2 weeks prior to commencement of the study.
13. Subject is a regular user (including recreational use) of any illicit drugs, or has a history of drug or alcohol abuse.
14. Subject has a history of significant drug allergy or any clinically significant adverse experience (e.g., drug-related rash, urticaria, anaphylaxis) related to the administration of sumatriptan, other triptans or any other marketed or investigational drug.
15. Subject has a history of syncope.
16. Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study.
17. Subject is taking prescription or nonprescription medicines that cannot be discontinued 2 weeks prior to the study day (including herbal remedies such as St. John’s Wort), or is a current user of sumatriptan or other triptan or is a current user of monoamine oxidase (MAO) inhibitors or selective serotonin reuptake inhibitors (SSRIs).

E.5 End points

E.5.1

Primary end point(s)

Safety and Tolerability

E.5.1.1

Timepoint(s) of evaluation of this end point

20, 40, 60, 80, 100 minutes postdose and 2, 3, 4, 6, 8, and 24 hours postdose

E.5.2

Secondary end point(s)

AUC, Cmax, Tmax, and terminal t1/2

E.5.2.1

Timepoint(s) of evaluation of this end point

20, 40, 60, 80, 100 minutes postdose and 2, 3, 4, 6, 8, and 24 hours postdose

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

E.6.6

Pharmacokinetic

Yes

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)

Yes

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)

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

E.8.1.6

Cross over

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.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

United States

E.8.7

Trial has a data monitoring committee

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception