Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
Autistic Disorder, Autism, Asperger's Disorder
About this trial
This is an interventional treatment trial for Autistic Disorder focused on measuring Asperger's, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Memantine, Pediatric Disorder, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 (NCT01592786)
- Met responder criterion at two consecutive visits separated by at least two weeks in lead-in study MEM-MD-91
- Provide written informed assent, when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. The parent/guardian/LAR must provide written informed consent before the patient's participation in the study. A separate written informed consent for the caregiver must also be obtained before the conduct of any study specific procedures
- Have a knowledgeable caregiver who is capable of providing reliable information about the patient's condition, attending all clinic visits with the patient, and overseeing the administration of study drug. Every effort should be made to maintain the same caregiver as used in the lead-in study throughout this study
- Have normal results from the physical examination, laboratory tests, ECG, and vital signs at Visit 1 of this study (last visit of Study MEM-MD-91). Any abnormal findings must be deemed not clinically significant by the Investigator and documented
- Be able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), as well as have a caregiver and parent/guardian/LAR who is able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), to comprehend the nature of the study and to allow for the completion of all study assessments
- 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
- Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1
- Age of 6 years to 12 years at the time of entry into lead in study MEM-MD-91
Exclusion Criteria:
- 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, the 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 C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior.
- Patients with evidence or history of malignancy (other than excised basal cell carcinoma) or any significant hematologic, endocrine, cardiovascular (including any rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease
- Female patients of child-bearing potential who are not using or not willing to use a conventional method of contraception approved by the PI. Abstinence is an acceptable method of contraception
- Patients requiring treatment with prohibited concomitant medications
- Patients who, in the opinion of the Investigator, might not be suitable for the study
- Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center
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 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 056
- Forest Investigative Site 106
- Forest Investigative Site 061
- Forest Investigative Site 095
- 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 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 071
- Forest Investigative Site 119
- Forest Investigative Site 063
- Forest Investigative Site 204
- Forest Investigative Site 203
- Forest Investigative Site 228
- 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 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 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 728
- Forest Investigative Site 807
- Forest Investigative Site 802
- Forest Investigative Site 804
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Memantine 1
Memantine 2
Placebo
Patients randomized to the full dose arm will continue taking memantine at the same tolerability and weight-based dose achieved in lead-in Study MEM-MD-91. Dosing will be once daily for up to 12 weeks.
Patients randomized to the reduced dose arm will take memantine at the tolerability and weight based dose that they received in lead in Study MEM-MD-91 reduced by at least 50%. Dosing will be once daily for up to 12 weeks.
Dosing will be once daily for up to 12 weeks.