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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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Kansas
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Kentucky
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Louisiana
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United States of America
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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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Italy
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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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Poland
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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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Spain
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Barcelona
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Spain
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Málaga
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Spain
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01592786