Clinical trial NCT01592773: 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 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
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: Autistic Disorder
Asperger's Disorder
Asperger's
Pediatric Autism
Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Pervasive Child Development Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 747
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 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).

Detailed description: This clinical study was a 48-week, multicenter, multinational, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at 106 study centers. Patients were eligible for this long-term extension study if they had:

* completed the open-label Study MEM MD 67,or
* completed the open-label Study MEM-MD-91, or
* completed the double-blind Study MEM-MD-68, or
* discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response

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

The decision to close the study early was based on data from 2 double-blind placebo-controlled studies (MEM-MD-57A and MEM-MD-68) that failed to demonstrate a statistically significant difference between memantine and placebo in the primary efficacy parameter based on Social Responsiveness Scale (SRS) total raw score.

Eligibility criteria: 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

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

Primary outcomes:
measure: Patients With Any Treatment-emergent Adverse Event
timeFrame: Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Forest Investigative Site 068
state: Alabama
city: Phoenix
country: United States
facility: Forest Investigative Site 005
state: Arizona
city: Tucson
country: United States
facility: Forest Investigative Site 055
state: Arizona
city: Little Rock
country: United States
facility: Forest Investigative Site 077
state: Arkansas
city: Glendale
country: United States
facility: Forest Investigative Site 054
state: California
city: Imperial
country: United States
facility: Forest Investigative Site 109
state: California
city: Irvine
country: United States
facility: Forest Investigative Site 066
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 096
state: California
city: San Francisco
country: United States
facility: Forest Investigative Site 021
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 026
state: California
city: Stanford
country: United States
facility: Forest Investigative Site 002
state: California
city: Boulder
country: United States
facility: Forest Investigative Site 078
state: Colorado
city: Centennial
country: United States
facility: Forest Investigative Site 073
state: Colorado
city: Washington
country: United States
facility: Forest Investigative Site 052
state: District of Columbia
city: Bradenton
country: United States
facility: Forest Investigative Site 075
state: Florida
city: Gainesville
country: United States
facility: Forest Investigative Site 080
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 117
state: Florida
city: Maitland
country: United States
facility: Forest Investigative Site 065
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 118
state: Florida
city: Oakland Park
country: United States
facility: Forest Investigative Site 085
state: Florida
city: Orange City
country: United States
facility: Forest Investigative Site 115
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 125
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 062
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 067
state: Florida
city: Wellington
country: United States
facility: Forest Investigative Site 101
state: Florida
city: Libertyville
country: United States
facility: Forest Investigative Site 102
state: Illinois
city: Naperville
country: United States
facility: Forest Investigative Site 023
state: Illinois
city: Evansville
country: United States
facility: Forest Investigative Site 082
state: Indiana
city: Fort Wayne
country: United States
facility: Forest Investigative Site 123
state: Indiana
city: Indianapolis
country: United States
facility: Forest Investigative Site 056
state: Indiana
city: Louisville
country: United States
facility: Forest Investigative Site 061
state: Kentucky
city: Lake Charles
country: United States
facility: Forest Investigative Site 095
state: Louisiana
city: New Orleans
country: United States
facility: Forest Investigative Site 091
state: Louisiana
city: Rockville
country: United States
facility: Forest Investigative Site 086
state: Maryland
city: Newton
country: United States
facility: Forest Investigative Site 059
state: Massachusetts
city: Springfield
country: United States
facility: Forest Investigative Site 108
state: Massachusetts
city: Lincoln
country: United States
facility: Forest Investigative Site 116
state: Nebraska
city: Lincoln
country: United States
facility: Forest Investigative Site 097
state: Nebraska
city: Henderson
country: United States
facility: Forest Investigative Site 130
state: Nevada
city: Las Vegas
country: United States
facility: Forest Investigative Site 104
state: Nevada
city: Neptune
country: United States
facility: Forest Investigative Site 136
state: New Jersey
city: Toms River
country: United States
facility: Forest Investigative Site 127
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 081
state: New Mexico
city: Albuquerque
country: United States
facility: Forest Investigative Site 107
state: New Mexico
city: Bronx
country: United States
facility: Forest Investigative Site 098
state: New York
city: Chapel Hill
country: United States
facility: Forest Investigative Site 072
state: North Carolina
city: Avon Lake
country: United States
facility: Forest Investigative Site 069
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 001
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 019
state: Oklahoma
city: Tulsa
country: United States
facility: Forest Investigative Site 092
state: Oklahoma
city: Gresham
country: United States
facility: Forest Investigative Site 053
state: Oregon
city: Johnstown
country: United States
facility: Forest Investigative Site 132
state: Pennsylvania
city: McMurray
country: United States
facility: Forest Investigative Site 131
state: Pennsylvania
city: Media
country: United States
facility: Forest Investigative Site 100
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site 105
state: South Carolina
city: Memphis
country: United States
facility: Forest Investigative Site 090
state: Tennessee
city: Nashville
country: United States
facility: Forest Investigative Site 057
state: Tennessee
city: Houston
country: United States
facility: Forest Investigative Site 051
state: Texas
city: The Woodlands
country: United States
facility: Forest Investigative Site 070
state: Texas
city: Clinton
country: United States
facility: Forest Investigative Site 028
state: Utah
city: Ogden
country: United States
facility: Forest Investigative Site 141
state: Utah
city: Salt Lake City
country: United States
facility: Forest Investigative Site 029
state: Utah
city: Charlottesville
country: United States
facility: Forest Investigative Site 064
state: Virginia
city: Norfolk
country: United States
facility: Forest Investigative Site 113
state: Virginia
city: Roanoke
country: United States
facility: Forest Investigative Site 124
state: Virginia
city: Bothell
country: United States
facility: Forest Investigative Site 071
state: Washington
city: Charleston
country: United States
facility: Forest Investigative Site 119
state: West Virginia
city: Middleton
country: United States
facility: Forest Investigative Site 063
state: Wisconsin
city: Brussels
country: Belgium
facility: Forest Investigative Site 204
city: Jette
country: Belgium
facility: Forest Investigative Site 203
city: Toronto
country: Canada
facility: Forest Investigative Site 155
state: Ontario
city: Antioquia
country: Colombia
facility: Forest Investigative Site 228
state: Bello
city: Barranquilla
country: Colombia
facility: Forest Investigative Site 227
city: Bogota
country: Colombia
facility: Forest Investigative Site 226
city: Tallinn
country: Estonia
facility: Forest Investigative Site 276
city: Bron Cedex
country: France
facility: Forest Investigative Site 329
state: Rhone
city: Budapest
country: Hungary
facility: Forest Investigative Site 381
city: Budapest
country: Hungary
facility: Forest Investigative Site 376
city: Budapest
country: Hungary
facility: Forest Investigative Site 378
city: Gyula
country: Hungary
facility: Forest Investigative Site 382
city: Kopavogur
country: Iceland
facility: Forest Investigative Site 401
city: Roma
country: Italy
facility: Forest Investigative Site 453
city: Siena
country: Italy
facility: Forest Investigative Site 452
city: Yangsan-si
country: Korea, Republic of
facility: Forest Investigative Site 704
state: Gyeongsangnam-do
city: Seoul
country: Korea, Republic of
facility: Forest Investigative Site 702
city: Seoul
country: Korea, Republic of
facility: Forest Investigative Site 703
city: Seoul
country: Korea, Republic of
facility: Forest Investigative Site 701
city: Wellington
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: Tyniec Maly
country: Poland
facility: Forest Investigative Site 576
city: Warsaw
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
city: Novi Sad
country: Serbia
facility: Forest Investigative Site 628
city: Bellville Cape Town
country: South Africa
facility: Forest Investigative Site 676
city: Barcelona
country: Spain
facility: Forest Investigative Site 729
city: Sabadell
country: Spain
facility: Forest Investigative Site 728
city: Torremolinos
country: Spain
facility: Forest Investigative Site 730
city: Donetsk
country: Ukraine
facility: Forest Investigative Site 803
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 807
city: Kherson
country: Ukraine
facility: Forest Investigative Site 802
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 804
city: Odessa
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:
citation: Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.