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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01592786




Registration number
NCT01592786
Ethics application status
Date submitted
3/05/2012
Date registered
7/05/2012
Date last updated
7/08/2014

Titles & IDs
Public title
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Scientific title
An Open-Label 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)
Secondary ID [1] 0 0
MEM-MD-91
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder (ASD) 0 0
Autism 0 0
Autistic Disorder 0 0
Asperger's Disorder 0 0
Asperger's 0 0
Pediatric Autism 0 0
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Memantine Hydrochloride (HCl)

Experimental: Memantine Hydrochloride (HCl) - Once daily oral administration of open-label memantine for up to 48 weeks: 6-week dose-titration period followed by up to 42-week maintenance period.


Treatment: Drugs: Memantine Hydrochloride (HCl)
Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Confirmed Social Responsiveness Scale (SRS) Responders
Timepoint [1] 0 0
Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)

Eligibility
Key inclusion criteria
1. Male or female outpatients.

2. Age of 6-12.

3. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or Pervasive
Developmental Disorder Not Otherwise Specified (PDD-NOS)

4. 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
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have enrolled in Study MEM-MD-57A

2. Medical conditions that might interfere with the conduct of the study, confound
interpretation of the study results, or endanger the patient's well-being.

3. Participation in any other clinical investigation using an experimental drug within 30
days of screening.

4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's
Disorder, and PDD-NOS.

5. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise
specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder
within the past 6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
906
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Forest Investigative Site 177 - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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District of Columbia
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United States of America
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Florida
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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United States of America
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Wisconsin
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Hoboken
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Belgium
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Leuven
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Canada
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Ontario
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Colombia
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Barranquilla
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Colombia
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Bello
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Colombia
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Bogota
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Estonia
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Tallinn
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France
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Rhone
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France
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Paris
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Hungary
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Budapest
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Hungary
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Gyula
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Hungary
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Szeged
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Iceland
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Kopavogur
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Roma
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Italy
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Siena
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Korea, Republic of
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Gyeongsangnam-do
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Korea, Republic of
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Seoul
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New Zealand
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Wellington
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Poland
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Gdansk
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Kielce
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Poland
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Kobierzyce
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Poland
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Warszawa
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Novi Sad
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Singapore
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Singapore
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South Africa
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Western Cape
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Barcelona
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Málaga
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Madrid
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Ukraine
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Vil. Stepanivka
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
State/province [69] 0 0
Odesa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Forest Laboratories
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability of memantine in
pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive
Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for
participation in a follow-up randomized withdrawal study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01592786
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jordan Lateiner, MS, MBA
Address 0 0
Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01592786