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

Completed · Phase 2 · Has a placebo group

Conditions studied: Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome, Autism Spectrum Disorders, Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)

In brief

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).

Key facts

Study ID: NCT01592747
Run by: Forest Laboratories
People needed: 479
Starts: 2012-09-01
Expected to finish: 2013-10-01
Last updated by the study team: 2019-04-24

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 (NCT01592786)
Met responder criterion at two consecutive visits separated by at least two weeks in lead-in study MEM-MD-91
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
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
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
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
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
Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1
Age of 6 years to 12 years at the time of entry into lead in study MEM-MD-91

You may not qualify if…

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
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.
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
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
Patients requiring treatment with prohibited concomitant medications
Patients who, in the opinion of the Investigator, might not be suitable for the study
Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center

Where it is running

Forest Investigative Site 005 — Phoenix, Arizona, United States
Forest Investigative Site 055 — Tucson, Arizona, United States
Forest Investigative Site 077 — Little Rock, Arkansas, United States
Forest Investigative Site 054 — Glendale, California, United States
Forest Investigative Site 109 — Imperial, California, United States
Forest Investigative Site 096 — Los Angeles, California, United States
Forest Investigative Site 021 — San Francisco, California, United States
Forest Investigative Site 026 — Santa Ana, California, United States
Forest Investigative Site 002 — Stanford, California, United States
Forest Investigative Site 078 — Boulder, Colorado, United States
Forest Investigative Site 073 — Centennial, Colorado, United States
Forest Investigative Site 052 — Washington D.C., District of Columbia, United States
Forest Investigative Site 075 — Bradenton, Florida, United States
Forest Investigative Site 080 — Gainesville, Florida, United States
Forest Investigative Site 117 — Jacksonville, Florida, United States
Forest Investigative Site 065 — Maitland, Florida, United States
Forest Investigative Site 118 — Miami, Florida, United States
Forest Investigative Site 085 — Oakland Park, Florida, United States
Forest Investigative Site 115 — Orange City, Florida, United States
Forest Investigative Site 125 — Orlando, Florida, United States
Forest Investigative Site 062 — Orlando, Florida, United States
Forest Investigative Site 067 — Tampa, Florida, United States
Forest Investigative Site 101 — Wellington, Florida, United States
Forest Investigative Site 102 — Libertyville, Illinois, United States
Forest Investigative Site 068 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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