Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
Condition: Autistic Disorder; Autism; Asperger's Disorder; Asperger Syndrome; Autism Spectrum Disorders; Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Developmental Disabilities; Child Development Disorders, Pervasive; Asperger Syndrome
Intervention: Memantine Hydrochloride (HCl); Memantine Hydrochloride (HCl); Placebo capsules
Intervention description: Extended Release Dose ranging from 3-15mg/day; administered orally; Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally.; Once daily, oral administration.
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 479.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Asperger's; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS); Memantine; Pediatric Disorder; Randomized Controlled Trial

Summary:

      The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and
      efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's
      Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91
             (NCT01592786)

          2. Met responder criterion at two consecutive visits separated by at least two weeks in
             lead-in study MEM-MD-91

          3. 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 before 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

          4. 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 study drug. Every effort should be made to maintain the same
             caregiver as used in the lead-in study throughout this study

          5. Have normal results from the physical examination, laboratory tests, ECG, and vital
             signs at Visit 1 of this study (last visit of Study MEM-MD-91). Any abnormal findings
             must be deemed not clinically significant by the Investigator and documented

          6. 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

          7. 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

          8. Females who are 9 years and older or who have had onset of menses must have a negative
             urine pregnancy test at Visit 1

          9. Age of 6 years to 12 years at the time of entry into lead in study MEM-MD-91

        Exclusion Criteria:

          1. 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

          2. Significant risk of suicidality based on the Investigator's judgment, the Aberrant
             Behavior Checklist-Irritability subscale (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 C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior.

          3. 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

          4. 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

          5. Patients requiring treatment with prohibited concomitant medications

          6. Patients who, in the opinion of the Investigator, might not be suitable for the study

          7. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its
             affiliates or partners, or the study center