Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01592747
First received: May 3, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

This clinical study will be a 12-week, multicenter, double-blind, placebo-controlled, randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). The objective is to evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo.


Condition Intervention Phase
Autism Spectrum Disorder (ASD)
Autism
Autistic Disorder
Asperger's Disorder
Asperger's
Pediatric Autism
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Pervasive Child Development Disorder
Drug: Memantine Hydrochloride (HCl)
Drug: Placebo capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • The primary outcome measure in this study will be the proportion of patients meeting the criterion for Loss of Therapeutic Response (LTR) by the end of the study. [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    The primary outcome measure in this study will be the proportion of patients meeting the criterion for Loss of Therapeutic Response (LTR) by the end of the study (Visit 7/Week 12).


Secondary Outcome Measures:
  • Children's Communication Checklist-2 (CCC-2) [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Time to the first visit when a patient shows LTR following randomization to memantine or placebo (time to the first LTR) [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]

Enrollment: 480
Study Start Date: September 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine 1
Patients randomized to the full dose arm will continue taking memantine at the same tolerability and weight based dose achieved in lead-in Study MEM-MD-91
Drug: Memantine Hydrochloride (HCl)
Patients randomized to the full dose arm will continue taking memantine at the same tolerability and weight based dose achieved in lead-in Study MEM-MD-91. Dosing will be once daily for 12 weeks.
Experimental: Memantine 2
Patients randomized to the reduced dose arm will take memantine at the tolerability and weight based dose that they received in lead in Study MEM-MD-91 reduced by at least 50%.
Drug: Memantine Hydrochloride (HCl)
Patients randomized to the reduced dose arm will take memantine at the tolerability and weight based dose that they received in lead in Study MEM-MD-91 reduced by at least 50%. Dosing will be once daily for 12 weeks.
Placebo Comparator: Placebo
Patients randomized to the placebo.
Drug: Placebo capsules
Patients randomized to the placebo will be dosed once daily for 12 weeks.

Detailed Description:

This clinical study will be a 12-week, multicenter, double-blind, placebo-controlled, randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) conducted at approximately 180 study centers. Patients who completed at least 12 weeks of study drug exposure during lead-in study MEM-MD-91 and meet protocol specified responder criteria.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91
  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

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
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592747

  Show 131 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Jordan Lateiner, MS, MBA Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01592747     History of Changes
Other Study ID Numbers: MEM-MD-68
Study First Received: May 3, 2012
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration
Canada: Public Health Agency of Canada

Keywords provided by Forest Laboratories:
Asperger's
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Memantine
Pervasive Child Development Disorder
Pediatric Disorder
Randomized Controlled Trial

Additional relevant MeSH terms:
Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Developmental Disabilities
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014