Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor withdrew funds
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Treatment as usual plus placebo |
|
| memantine | Active Comparator | Treatment as usual plus memantine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| memantine | Drug | memantine 5-20 mg daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Scale(CGI-S) | 12 weeks |
Not provided
Not provided
Inclusion criteria
Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC)
Participant has a diagnosis of:
Participant meets one of the following criteria:
CGI-S >= 4 (CGI-S: ________)
Participant has the following problematic behaviors (at least one) that might be expected to benefit from memantine:
Exclusion criteria
The patient meets none of the following criteria (mark if absent):
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Samstad, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36006807 | Derived | 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. |
Not provided
Not provided
4 participants were enrolled in this study. It was terminated prematurely and the P.I. was never un-blinded. In an attempt to enter the information which was obtained within the confines of the system, all enrollment information and baseline characteristics have been entered into the experimental arm.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Treatment as usual plus memantine memantine: memantine 5-20 mg daily OR Treatment as usual plus Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Treatment as usual plus memantine memantine: memantine 5-20 mg daily OR Treatment as usual plus Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Global Impression-Scale(CGI-S) | This study was terminated prematurely and data was not collected for this outcome measure. | Posted | 12 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Treatment as usual plus memantine memantine: memantine 5-20 mg daily OR Treatment as usual plus Placebo |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Samstad, MD | Johns Hopkins University School of Medicine | 410-550-0171 | esamsta1@jhmi.edu |
Not provided
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Look-alike placebo |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
Not provided
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |