Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
- Conditions
- Autism Spectrum Disorder (ASD)Autistic DisorderAutismAsperger's DisorderAsperger'sPediatric AutismPervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
- Interventions
- Registration Number
- NCT01592773
- Lead Sponsor
- Forest Laboratories
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 747
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Memantine Memantine Hydrochloride (HCl) 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.
- Primary Outcome Measures
Name Time Method Patients With Any Treatment-emergent Adverse Event Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit Number of patients who experienced 1 or more Treatment Emergent Adverse Event
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (106)
Forest Investigative Site 116
🇺🇸Lincoln, Nebraska, United States
Forest Investigative Site 579
🇵🇱Gdansk, Poland
Forest Investigative Site 576
🇵🇱Tyniec Maly, Poland
Forest Investigative Site 096
🇺🇸Los Angeles, California, United States
Forest Investigative Site 676
🇿🇦Bellville Cape Town, South Africa
Forest Investigative Site 226
🇨🇴Bogota, Colombia
Forest Investigative Site 627
🇷🇸Belgrade, Serbia
Forest Investigative Site 629
🇷🇸Nis, Serbia
Forest Investigative Site 097
🇺🇸Lincoln, Nebraska, United States
Forest Investigative Site 082
🇺🇸Evansville, Indiana, United States
Forest Investigative Site 086
🇺🇸Rockville, Maryland, United States
Forest Investigative Site 136
🇺🇸Neptune, New Jersey, United States
Forest Investigative Site 203
🇧🇪Jette, Belgium
Forest Investigative Site 081
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 023
🇺🇸Naperville, Illinois, United States
Forest Investigative Site 127
🇺🇸Toms River, New Jersey, United States
Forest Investigative Site 069
🇺🇸Avon Lake, Ohio, United States
Forest Investigative Site 115
🇺🇸Orange City, Florida, United States
Forest Investigative Site 002
🇺🇸Stanford, California, United States
Forest Investigative Site 801
🇺🇦Odessa, Ukraine
Forest Investigative Site 001
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 107
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 059
🇺🇸Newton, Massachusetts, United States
Forest Investigative Site 102
🇺🇸Libertyville, Illinois, United States
Forest Investigative Site 453
🇮🇹Roma, Italy
Forest Investigative Site 092
🇺🇸Tulsa, Oklahoma, United States
Forest Investigative Site 119
🇺🇸Charleston, West Virginia, United States
Forest Investigative Site 113
🇺🇸Norfolk, Virginia, United States
Forest Investigative Site 703
🇰🇷Seoul, Korea, Republic of
Forest Investigative Site 704
🇰🇷Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Forest Investigative Site 070
🇺🇸The Woodlands, Texas, United States
Forest Investigative Site 124
🇺🇸Roanoke, Virginia, United States
Forest Investigative Site 063
🇺🇸Middleton, Wisconsin, United States
Forest Investigative Site 329
🇫🇷Bron Cedex, Rhone, France
Forest Investigative Site 382
🇭🇺Gyula, Hungary
Forest Investigative Site 526
🇳🇿Wellington, New Zealand
Forest Investigative Site 578
🇵🇱Gdansk, Poland
Forest Investigative Site 452
🇮🇹Siena, Italy
Forest Investigative Site 702
🇰🇷Seoul, Korea, Republic of
Forest Investigative Site 577
🇵🇱Warsaw, Poland
Forest Investigative Site 701
🇰🇷Seoul, Korea, Republic of
Forest Investigative Site 730
🇪🇸Torremolinos, Spain
Forest Investigative Site 056
🇺🇸Indianapolis, Indiana, United States
Forest Investigative Site 052
🇺🇸Washington, District of Columbia, United States
Forest Investigative Site 085
🇺🇸Oakland Park, Florida, United States
Forest Investigative Site 055
🇺🇸Tucson, Arizona, United States
Forest Investigative Site 077
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 068
🇺🇸Dothan, Alabama, United States
Forest Investigative Site 109
🇺🇸Imperial, California, United States
Forest Investigative Site 066
🇺🇸Irvine, California, United States
Forest Investigative Site 026
🇺🇸Santa Ana, California, United States
Forest Investigative Site 078
🇺🇸Boulder, Colorado, United States
Forest Investigative Site 073
🇺🇸Centennial, Colorado, United States
Forest Investigative Site 075
🇺🇸Bradenton, Florida, United States
Forest Investigative Site 117
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 118
🇺🇸Miami, Florida, United States
Forest Investigative Site 155
🇨🇦Toronto, Ontario, Canada
Forest Investigative Site 071
🇺🇸Bothell, Washington, United States
Forest Investigative Site 376
🇭🇺Budapest, Hungary
Forest Investigative Site 728
🇪🇸Sabadell, Spain
Forest Investigative Site 381
🇭🇺Budapest, Hungary
Forest Investigative Site 729
🇪🇸Barcelona, Spain
Forest Investigative Site 123
🇺🇸Fort Wayne, Indiana, United States
Forest Investigative Site 095
🇺🇸Lake Charles, Louisiana, United States
Forest Investigative Site 054
🇺🇸Glendale, California, United States
Forest Investigative Site 065
🇺🇸Maitland, Florida, United States
Forest Investigative Site 064
🇺🇸Charlottesville, Virginia, United States
Forest Investigative Site 108
🇺🇸Springfield, Massachusetts, United States
Forest Investigative Site 090
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 132
🇺🇸Johnstown, Pennsylvania, United States
Forest Investigative Site 053
🇺🇸Gresham, Oregon, United States
Forest Investigative Site 100
🇺🇸Media, Pennsylvania, United States
Forest Investigative Site 051
🇺🇸Houston, Texas, United States
Forest Investigative Site 028
🇺🇸Clinton, Utah, United States
Forest Investigative Site 130
🇺🇸Henderson, Nevada, United States
Forest Investigative Site 131
🇺🇸McMurray, Pennsylvania, United States
Forest Investigative Site 141
🇺🇸Ogden, Utah, United States
Forest Investigative Site 378
🇭🇺Budapest, Hungary
Forest Investigative Site 021
🇺🇸San Francisco, California, United States
Forest Investigative Site 005
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 057
🇺🇸Nashville, Tennessee, United States
Forest Investigative Site 125
🇺🇸Orlando, Florida, United States
Forest Investigative Site 062
🇺🇸Orlando, Florida, United States
Forest Investigative Site 067
🇺🇸Tampa, Florida, United States
Forest Investigative Site 061
🇺🇸Louisville, Kentucky, United States
Forest Investigative Site 104
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 019
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 029
🇺🇸Salt Lake City, Utah, United States
Forest Investigative Site 276
🇪🇪Tallinn, Estonia
Forest Investigative Site 580
🇵🇱Kielce, Poland
Forest Investigative Site 626
🇷🇸Belgrade, Serbia
Forest Investigative Site 628
🇷🇸Novi Sad, Serbia
Forest Investigative Site 227
🇨🇴Barranquilla, Colombia
Forest Investigative Site 401
🇮🇸Kopavogur, Iceland
Forest Investigative Site 228
🇨🇴Antioquia, Bello, Colombia
Forest Investigative Site 803
🇺🇦Donetsk, Ukraine
Forest Investigative Site 807
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 802
🇺🇦Kherson, Ukraine
Forest Investigative Site 804
🇺🇦Kyiv, Ukraine
Forest Investigative Site 204
🇧🇪Brussels, Belgium
Forest Investigative Site 080
🇺🇸Gainesville, Florida, United States
Forest Investigative Site 091
🇺🇸New Orleans, Louisiana, United States
Forest Investigative Site 072
🇺🇸Chapel Hill, North Carolina, United States
Forest Investigative Site 105
🇺🇸Charleston, South Carolina, United States
Forest Investigative Site 098
🇺🇸Bronx, New York, United States
Forest Investigative Site 101
🇺🇸Wellington, Florida, United States