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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - Number of patients who experienced 1 or more 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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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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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Oregon
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Pennsylvania
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Tennessee
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Texas
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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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Bello
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Bogota
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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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Seoul
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Wellington
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Gdansk
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Kielce
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Tyniec Maly
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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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Bellville Cape Town
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Barcelona
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Sabadell
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Torremolinos
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Ukraine
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Kharkiv
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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/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/show/NCT01592773