Clinical Trials Register

Summary
EudraCT Number:	2012-001630-33
Sponsor's Protocol Code Number:	MEM-MD-69
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-07-18
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2012-001630-33

A.3

Full title of the trial

An Open-Label Extension Study of the Safety and Tolerability of Memantine
in Pediatric Patients with Autism, Asperger’s Disorder or Pervasive
Developmental Disorder Not Otherwise Specified (PDD-NOS)

A.3.1

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

A.4.1

Sponsor's protocol code number

MEM-MD-69

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Forest Research Institute, 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	Forest Research Institute United States
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	Quintiles Contact Center
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	The Alba Campus
B.5.3.2	Town/ city	Rosebank, Livingston
B.5.3.3	Post code	EH54 7EG
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	862 261 3634
B.5.5	Fax number	not applicable
B.5.6	E-mail	QEudraCThelpdesk@quintilescontact.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	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.3.1	Product name	Memantine Hydrochloride
D.3.2	Product code	MRZ 2/145
D.3.4	Pharmaceutical form	Prolonged-release capsule
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.3.8	INN - Proposed INN	MEMANTINE HYDROCHLORIDE
D.3.9.1	CAS number	4110-52-1
D.3.9.4	EV Substance Code	SUB03137MIG
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	6
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.IMP: 2
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.3.1	Product name	Memantine Hydrochloride
D.3.2	Product code	MRZ 2/145
D.3.4	Pharmaceutical form	Prolonged-release capsule
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.3.8	INN - Proposed INN	MEMANTINE HYDROCHLORIDE
D.3.9.1	CAS number	4110-52-1
D.3.9.4	EV Substance Code	SUB03137MIG
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	3
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	Prolonged-release capsule
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

Autism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine

E.1.1.1

Medical condition in easily understood language

Autism Previously Treated with Memantine

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10008520
E.1.2	Term	Childhood autism
E.1.2	System Organ Class	100000004852

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	PT
E.1.2	Classification code	10003484
E.1.2	Term	Asperger's disorder
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10034739
E.1.2	Term	Pervasive developmental disorder NOS
E.1.2	System Organ Class	10037175 - Psychiatric 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 evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger’s Disorder or Pervasive Developmental Disorder Not Otherwise Specified
(PDD-NOS).

E.2.2

Secondary objectives of the trial

Not Applicable - no secondary objectives

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

To be eligible to participate in the study, patients must meet the following criteria:
1. Provide written informed assent, when developmentally appropriate, to participate in
the study before conduct of any study-specific procedures. The parent/guardian/LAR
must provide written informed consent for the patient’s participation in the study. A
separate written informed consent for the caregiver must also be obtained before the
conduct of any study-specific procedures
2. Have a knowledgeable caregiver who is capable of providing reliable information
about the patient’s condition, attending all clinic visits with the patient, and
overseeing the administration of investigational product. Every effort should be made
to maintain the same caregiver as used in the preceding study throughout this study
3. Patients who completed Study MEM-MD-67, MEM-MD-68 or MEM-MD-91.
Patients who discontinued Study MEM-MD-68 due to meeting the criterion for loss
of therapeutic response. Sponsor approval is required before enrolling any other
patient who discontinued a preceding memantine study
4. Females who are 9 years and older or who have had onset of menses must have a
negative urine pregnancy test at Visit 1
5. Have normal results from a physical examination and laboratory tests at Visit 1 of this
study (last visit of the preceding study). Any abnormal findings must be deemed not
clinically significant by the Investigator and documented
6. Have a family that is sufficiently organized and stable to guarantee adequate safety
monitoring and continuous attendance to clinic visits for the duration of the study
7. Be able to speak and understand English sufficiently (or their native language if this
can be accommodated by the site), as well as have a caregiver and
parent/guardian/LAR who is able to speak and understand English sufficiently
(or their native language if this can be accommodated by the site), to comprehend the
nature of the study and to allow for the completion of all study assessments

E.4

Principal exclusion criteria

Patients who meet any of the following criteria will not be eligible to participate in the study:
1. Patients who discontinued a preceding memantine study due to an adverse event
possibly related to study drug
2. Patients with a concurrent medical condition that might interfere with the conduct of
the study, confound interpretation of the study results, or endanger the patient’s well
being
3. Significant risk of suicidality based on the Investigator’s judgment, ABC-I, or if
appropriate, as indicated by a response of “yes” to questions 4 or 5 in the suicidal
ideation section of the Children’s Columbia-Suicide Severity Rating Scale (C-SSRS)
or any suicidal behavior
4. Patients with evidence or history of malignancy (other than excised basal cell
carcinoma) or any significant hematologic, endocrine, cardiovascular (including any
rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease
5. Female patients of child-bearing potential who are not using or not willing to use a
conventional method of contraception approved by the PI. Abstinence is an
acceptable method of contraception
6. Patients requiring treatment with disallowed concomitant medications (Appendix III)
7. Patients who, in the Investigator’s opinion, might not be suitable for the study
8. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of
its affiliates or partners, or the study center

E.5 End points

E.5.1

Primary end point(s)

Standard safety assessments are being conducted to align withthe main objectives of the study stated in E.2.1. exploratory efficacy assessment evaluation.

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety assessments are evaluated at:
Visit 1 (End of Week 0)
Visit 4 (End of Week 6)
Visit 5 (End of Week 12)
Visit 6 (End of Week 24)
Visit 7 (End of Week 36)
Visit 8/Early Termination (End of Week 48)

E.5.2

Secondary end point(s)

Exploratory efficacy assessment evaluation.

E.5.2.1

Timepoint(s) of evaluation of this end point

Exploratory Efficacy assessments are evaluated at:
Visit 1 (End of Week 0)
Visit 4 (End of Week 6)
Visit 5 (End of Week 12)
Visit 6 (End of Week 24)
Visit 7 (End of Week 36)
Visit 8/Early Termination (End of Week 48)

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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.8.5

The trial involves multiple Member States

Yes

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

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

Australia

Belgium

Colombia

Denmark

Finland

France

Germany

Hungary

Iceland

Ireland

Italy

Korea, Republic of

Mexico

Netherlands

New Zealand

Philippines

Poland

Russian Federation

Serbia

Singapore

Slovakia

South Africa

Spain

Sweden

Taiwan

Thailand

Ukraine

United Kingdom

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.8.9.1

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 months

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:

450

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:

380

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

The patient's parent/guardian/LAR will provide informed consent. When determined the child is capable of assent, child assent will also be obtained.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

450

F.4.2.2

In the whole clinical trial

900

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Memantine is investigational for this indication and is not available for purchase for this indication. After the patients complete or early terminate from the study, they will no longer have access to the study drug.Patients who complete MEM-MD-69 will return to standard of care, which may include treatments that have been approved for some of the commonly co-existing symptoms of ASD, such as anxiety, depression, obsessive-compulsive disorder and sevire maladaptive behavioural problems.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Medicines for Children Research Network
G.4.3.4	Network Country	United Kingdom

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-10-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-09-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-31

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