Back to resultsSafety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Primary Purpose
Autism Spectrum Disorder (ASD), Autism, Autistic Disorder
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Memantine Hydrochloride (HCl)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder (ASD) focused on measuring Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Pervasive Child Development Disorder
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
Sites / Locations
- Forest Investigative Site 068
- Forest Investigative Site 005
- Forest Investigative Site 055
- Forest Investigative Site 077
- Forest Investigative Site 054
- Forest Investigative Site 109
- Forest Investigative Site 066
- Forest Investigative Site 096
- Forest Investigative Site 021
- Forest Investigative Site 026
- Forest Investigative Site 002
- Forest Investigative Site 078
- Forest Investigative Site 073
- Forest Investigative Site 052
- Forest Investigative Site 075
- Forest Investigative Site 080
- Forest Investigative Site 117
- Forest Investigative Site 065
- Forest Investigative Site 118
- Forest Investigative Site 085
- Forest Investigative Site 115
- Forest Investigative Site 125
- Forest Investigative Site 062
- Forest Investigative Site 067
- Forest Investigative Site 101
- Forest Investigative Site 102
- Forest Investigative Site 023
- Forest Investigative Site 082
- Forest Investigative Site 123
- Forest Investigative Site 056
- Forest Investigative Site 061
- Forest Investigative Site 095
- Forest Investigative Site 091
- Forest Investigative Site 086
- Forest Investigative Site 059
- Forest Investigative Site 108
- Forest Investigative Site 116
- Forest Investigative Site 097
- Forest Investigative Site 130
- Forest Investigative Site 104
- Forest Investigative Site 136
- Forest Investigative Site 127
- Forest Investigative Site 081
- Forest Investigative Site 107
- Forest Investigative Site 098
- Forest Investigative Site 072
- Forest Investigative Site 069
- Forest Investigative Site 001
- Forest Investigative Site 019
- Forest Investigative Site 092
- Forest Investigative Site 053
- Forest Investigative Site 132
- Forest Investigative Site 131
- Forest Investigative Site 100
- Forest Investigative Site 105
- Forest Investigative Site 090
- Forest Investigative Site 057
- Forest Investigative Site 051
- Forest Investigative Site 070
- Forest Investigative Site 028
- Forest Investigative Site 141
- Forest Investigative Site 029
- Forest Investigative Site 064
- Forest Investigative Site 113
- Forest Investigative Site 124
- Forest Investigative Site 071
- Forest Investigative Site 119
- Forest Investigative Site 063
- Forest Investigative Site 204
- Forest Investigative Site 203
- Forest Investigative Site 155
- Forest Investigative Site 228
- Forest Investigative Site 227
- Forest Investigative Site 226
- Forest Investigative Site 276
- Forest Investigative Site 329
- Forest Investigative Site 381
- Forest Investigative Site 376
- Forest Investigative Site 378
- Forest Investigative Site 382
- Forest Investigative Site 401
- Forest Investigative Site 453
- Forest Investigative Site 452
- Forest Investigative Site 704
- Forest Investigative Site 702
- Forest Investigative Site 703
- Forest Investigative Site 701
- Forest Investigative Site 526
- Forest Investigative Site 579
- Forest Investigative Site 578
- Forest Investigative Site 580
- Forest Investigative Site 576
- Forest Investigative Site 577
- Forest Investigative Site 626
- Forest Investigative Site 627
- Forest Investigative Site 629
- Forest Investigative Site 628
- Forest Investigative Site 676
- Forest Investigative Site 729
- Forest Investigative Site 728
- Forest Investigative Site 730
- Forest Investigative Site 803
- Forest Investigative Site 807
- Forest Investigative Site 802
- Forest Investigative Site 804
- Forest Investigative Site 801
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Memantine
Arm Description
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.
Outcomes
Primary Outcome Measures
Patients With Any Treatment-emergent Adverse Event
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01592773
Brief Title
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
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated because primary efficacy parameter failed to demonstrate statistically significant difference between memantine and placebo in controlled trials
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
747 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Memantine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Memantine Hydrochloride (HCl)
Other Intervention Name(s)
Namenda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patients With Any Treatment-emergent Adverse Event
Description
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Time Frame
Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Lateiner, MS, MBA
Organizational Affiliation
Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 068
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Forest Investigative Site 005
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Forest Investigative Site 055
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Forest Investigative Site 077
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Facility Name
Forest Investigative Site 054
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Forest Investigative Site 109
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Forest Investigative Site 066
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Facility Name
Forest Investigative Site 096
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Forest Investigative Site 021
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0984
Country
United States
Facility Name
Forest Investigative Site 026
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Forest Investigative Site 002
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5719
Country
United States
Facility Name
Forest Investigative Site 078
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Forest Investigative Site 073
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Forest Investigative Site 052
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Forest Investigative Site 075
City
Bradenton
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Forest Investigative Site 080
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Forest Investigative Site 117
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Forest Investigative Site 065
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Forest Investigative Site 118
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Forest Investigative Site 085
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Forest Investigative Site 115
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Forest Investigative Site 125
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Forest Investigative Site 062
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 067
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Forest Investigative Site 101
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Forest Investigative Site 102
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Forest Investigative Site 023
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Forest Investigative Site 082
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Forest Investigative Site 123
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Forest Investigative Site 056
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Forest Investigative Site 061
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Forest Investigative Site 095
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Forest Investigative Site 091
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Forest Investigative Site 086
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Forest Investigative Site 059
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Forest Investigative Site 108
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Forest Investigative Site 116
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Forest Investigative Site 097
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Forest Investigative Site 130
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Forest Investigative Site 104
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Forest Investigative Site 136
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Forest Investigative Site 127
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Forest Investigative Site 081
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5129
Country
United States
Facility Name
Forest Investigative Site 107
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Forest Investigative Site 098
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Forest Investigative Site 072
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Forest Investigative Site 069
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
Forest Investigative Site 001
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Forest Investigative Site 019
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Forest Investigative Site 092
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Forest Investigative Site 053
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Forest Investigative Site 132
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States
Facility Name
Forest Investigative Site 131
City
McMurray
State/Province
Pennsylvania
ZIP/Postal Code
15317
Country
United States
Facility Name
Forest Investigative Site 100
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Forest Investigative Site 105
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Forest Investigative Site 090
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 057
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Forest Investigative Site 051
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Forest Investigative Site 070
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Forest Investigative Site 028
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Forest Investigative Site 141
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Forest Investigative Site 029
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Forest Investigative Site 064
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Forest Investigative Site 113
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Forest Investigative Site 124
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Forest Investigative Site 071
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Forest Investigative Site 119
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Forest Investigative Site 063
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Forest Investigative Site 204
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Forest Investigative Site 203
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Forest Investigative Site 155
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1T8
Country
Canada
Facility Name
Forest Investigative Site 228
City
Antioquia
State/Province
Bello
Country
Colombia
Facility Name
Forest Investigative Site 227
City
Barranquilla
ZIP/Postal Code
84176
Country
Colombia
Facility Name
Forest Investigative Site 226
City
Bogota
Country
Colombia
Facility Name
Forest Investigative Site 276
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Forest Investigative Site 329
City
Bron Cedex
State/Province
Rhone
ZIP/Postal Code
69500
Country
France
Facility Name
Forest Investigative Site 381
City
Budapest
ZIP/Postal Code
1026
Country
Hungary
Facility Name
Forest Investigative Site 376
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Forest Investigative Site 378
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Forest Investigative Site 382
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Forest Investigative Site 401
City
Kopavogur
ZIP/Postal Code
200
Country
Iceland
Facility Name
Forest Investigative Site 453
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Forest Investigative Site 452
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Forest Investigative Site 704
City
Yangsan-si
State/Province
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
Forest Investigative Site 702
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Forest Investigative Site 703
City
Seoul
ZIP/Postal Code
120752
Country
Korea, Republic of
Facility Name
Forest Investigative Site 701
City
Seoul
ZIP/Postal Code
138736
Country
Korea, Republic of
Facility Name
Forest Investigative Site 526
City
Wellington
ZIP/Postal Code
7902
Country
New Zealand
Facility Name
Forest Investigative Site 579
City
Gdansk
ZIP/Postal Code
80542
Country
Poland
Facility Name
Forest Investigative Site 578
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
Forest Investigative Site 580
City
Kielce
ZIP/Postal Code
25317
Country
Poland
Facility Name
Forest Investigative Site 576
City
Tyniec Maly
ZIP/Postal Code
55040
Country
Poland
Facility Name
Forest Investigative Site 577
City
Warsaw
ZIP/Postal Code
80214
Country
Poland
Facility Name
Forest Investigative Site 626
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 627
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 629
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Forest Investigative Site 628
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Forest Investigative Site 676
City
Bellville Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Forest Investigative Site 729
City
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Forest Investigative Site 728
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Forest Investigative Site 730
City
Torremolinos
ZIP/Postal Code
29620
Country
Spain
Facility Name
Forest Investigative Site 803
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
Forest Investigative Site 807
City
Kharkiv
ZIP/Postal Code
61153
Country
Ukraine
Facility Name
Forest Investigative Site 802
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Forest Investigative Site 804
City
Kyiv
ZIP/Postal Code
4080
Country
Ukraine
Facility Name
Forest Investigative Site 801
City
Odessa
ZIP/Postal Code
65014
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
36006807
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.
Results Reference
derived
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Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
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