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

Conditions: Autism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine
MedDRA version: 14.1Level: LLTClassification code 10008520Term: Childhood autismSystem Organ Class: 100000004852
MedDRA version: 14.1Level: PTClassification code 10003484Term: Asperger's disorderSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
MedDRA version: 14.1Level: LLTClassification code 10034739Term: Pervasive developmental disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders

Registration Number: EUCTR2012-001630-33-EE

Lead Sponsor: Forest Research Institute, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 450
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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<br>(PDD-NOS).;Secondary Objective: Not Applicable - no secondary objectives;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.;Timepoint(s) of evaluation of this end point: Safety assessments are evaluated at:<br>Visit 1 (End of Week 0)<br>Visit 4 (End of Week 6)<br>Visit 5 (End of Week 12)<br>Visit 6 (End of Week 24)<br>Visit 7 (End of Week 36)<br>Visit 8/Early Termination (End of Week 48)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Exploratory efficacy assessment evaluation.;Timepoint(s) of evaluation of this end point: Exploratory Efficacy assessments are evaluated at:<br>Visit 1 (End of Week 0)<br>Visit 4 (End of Week 6)<br>Visit 5 (End of Week 12)<br>Visit 6 (End of Week 24)<br>Visit 7 (End of Week 36)<br>Visit 8/Early Termination (End of Week 48)

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