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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/NCT01592773




Registration number
NCT01592773
Ethics application status
Date submitted
3/05/2012
Date registered
7/05/2012
Date last updated
16/02/2015

Titles & IDs
Public title
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 Extension 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-69
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 - To maintain the blind of the preceding study, patients who participated in MEM-MD-68 (NCT01592747) began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.
Patients who took open-label memantine in study MEM-MD-67 (NCT01999894) or MEM-MD-91(NCT01592786), received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.


Treatment: Drugs: Memantine Hydrochloride (HCl)
During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily.
During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patients With Any Treatment-emergent Adverse Event
Timepoint [1] 0 0
Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit

Eligibility
Key inclusion criteria
- Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study
MEM-MD-68 due to meeting the criterion for loss of therapeutic response.

- Having normal results from a physical examination and laboratory tests at Visit 1 of
this study (last visit of the preceding study). Any abnormal findings must be deemed
not clinically significant by the Investigator and documented as such.

- 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
- Patients who discontinued a preceding memantine study due to an adverse event possibly
related to study drug

- 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, 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 Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior

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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
747
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Illinois
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Indiana
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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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Wisconsin
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Belgium
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Brussels
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Belgium
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Jette
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Canada
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Ontario
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Colombia
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Bello
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Colombia
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Barranquilla
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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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Hungary
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Budapest
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Gyula
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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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Tyniec Maly
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Poland
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Warsaw
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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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South Africa
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Bellville Cape Town
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Spain
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Barcelona
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Sabadell
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Spain
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Torremolinos
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Ukraine
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Donetsk
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Kharkiv
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Ukraine
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Kherson
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Ukraine
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Kyiv
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Ukraine
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Odessa

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

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to evaluate the long-term safety and tolerability of memantine
in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive
Developmental Disorder Not Otherwise Specified (PDD-NOS).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01592773
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/NCT01592773