Clinical trial NCT01592786: An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder (ASD)
Autism
Autistic Disorder
Asperger's Disorder
Asperger's
Pediatric Autism
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Keywords: Autism Spectrum Disorder (ASD)
Autism
Autistic Disorder
Asperger's Disorder
Asperger's
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Memantine
Pediatric Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 906
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks).

Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. A responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score.

Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in this study were as follows:

* Group A: ≥ 60 kg; maximum 15 mg/day
* Group B: 40-59 kg; maximum 9 mg/day
* Group C: 20-39 kg; maximum 6 mg/day
* Group D: \< 20 kg; maximum 3 mg/day

Eligibility criteria: 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

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

Primary outcomes:
measure: Number of Confirmed Social Responsiveness Scale (SRS) Responders
timeFrame: Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Forest Investigative Site 068
state: Alabama
city: Phoenix
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facility: Forest Investigative Site 005
state: Arizona
city: Tucson
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facility: Forest Investigative Site 055
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city: Little Rock
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city: Glendale
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state: California
city: Imperial
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facility: Forest Investigative Site 109
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city: Irvine
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facility: Forest Investigative Site 066
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city: Los Angeles
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facility: Forest Investigative Site 096
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city: San Francisco
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facility: Forest Investigative Site 021
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city: Washington
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city: Bradenton
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facility: Forest Investigative Site 080
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city: Jacksonville
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facility: Forest Investigative Site 117
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city: Maitland
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facility: Forest Investigative Site 065
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city: Miami
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facility: Forest Investigative Site 118
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city: Oakland Park
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facility: Forest Investigative Site 085
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city: Orange City
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facility: Forest Investigative Site 115
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city: Orlando
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facility: Forest Investigative Site 124
state: Florida
city: Orlando
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facility: Forest Investigative Site 125
state: Florida
city: Orlando
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facility: Forest Investigative Site 062
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city: Orlando
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facility: Forest Investigative Site 114
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city: Tampa
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city: New Orleans
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city: Rockville
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facility: Forest Investigative Site 086
state: Maryland
city: Newton
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facility: Forest Investigative Site 059
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city: Springfield
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facility: Forest Investigative Site 108
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city: Lincoln
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facility: Forest Investigative Site 116
state: Nebraska
city: Lincoln
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facility: Forest Investigative Site 097
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city: Henderson
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facility: Forest Investigative Site 130
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city: Las Vegas
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city: Neptune
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city: Avon Lake
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facility: Forest Investigative Site 069
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city: Columbus
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facility: Forest Investigative Site 001
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 019
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city: Tulsa
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facility: Forest Investigative Site 092
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city: Gresham
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facility: Forest Investigative Site 053
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city: Johnstown
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facility: Forest Investigative Site 132
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city: McMurray
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facility: Forest Investigative Site 131
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city: Media
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facility: Forest Investigative Site 100
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city: Charleston
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facility: Forest Investigative Site 105
state: South Carolina
city: Memphis
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facility: Forest Investigative Site 090
state: Tennessee
city: Nashville
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facility: Forest Investigative Site 057
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city: Houston
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facility: Forest Investigative Site 051
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city: The Woodlands
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facility: Forest Investigative Site 070
state: Texas
city: Clinton
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facility: Forest Investigative Site 028
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city: Ogden
country: United States
facility: Forest Investigative Site 141
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city: Salt Lake City
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facility: Forest Investigative Site 029
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city: Charlottesville
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facility: Forest Investigative Site 064
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city: Norfolk
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facility: Forest Investigative Site 113
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city: Bothell
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facility: Forest Investigative Site 071
state: Washington
city: Charleston
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facility: Forest Investigative Site 119
state: West Virginia
city: Middleton
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facility: Forest Investigative Site 063
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city: Hoboken
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facility: Forest Investigative Site 202
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country: Belgium
facility: Forest Investigative Site 201
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country: Canada
facility: Forest Investigative Site 155
state: Ontario
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facility: Forest Investigative Site 227
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country: Estonia
facility: Forest Investigative Site 276
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state: Rhone
city: Paris
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city: Budapest
country: Hungary
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country: Hungary
facility: Forest Investigative Site 381
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country: Hungary
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facility: Forest Investigative Site 378
city: Gyula
country: Hungary
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facility: Forest Investigative Site 401
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facility: Forest Investigative Site 453
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country: Italy
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facility: Forest Investigative Site 704
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city: Seoul
country: Korea, Republic of
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country: New Zealand
facility: Forest Investigative Site 526
city: Gdansk
country: Poland
facility: Forest Investigative Site 579
city: Gdansk
country: Poland
facility: Forest Investigative Site 578
city: Kielce
country: Poland
facility: Forest Investigative Site 580
city: Kobierzyce
country: Poland
facility: Forest Investigative Site 576
city: Warszawa
country: Poland
facility: Forest Investigative Site 577
city: Belgrade
country: Serbia
facility: Forest Investigative Site 626
city: Belgrade
country: Serbia
facility: Forest Investigative Site 627
city: Nis
country: Serbia
facility: Forest Investigative Site 629
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country: Serbia
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city: Singapore
country: Singapore
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country: South Africa
facility: Forest Investigative Site 676
state: Western Cape
city: Sabadell
country: Spain
facility: Forest Investigative Site 728
state: Barcelona
city: Torremolinos
country: Spain
facility: Forest Investigative Site 730
state: Málaga
city: Barcelona
country: Spain
facility: Forest Investigative Site 729
city: Madrid
country: Spain
facility: Forest Investigative Site 727
city: Kherson
country: Ukraine
facility: Forest Investigative Site 802
state: Vil. Stepanivka
city: Donetsk
country: Ukraine
facility: Forest Investigative Site 803
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 807
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 804
city: Odesa
country: Ukraine
facility: Forest Investigative Site 801
Study officials:
affiliation: Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
name: Jordan Lateiner, MS, MBA
role: STUDY_DIRECTOR
References: