Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Autism Spectrum Disorder (ASD), Autism, Autistic Disorder
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
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.