Phase 4
N=19
A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
Autism Spectrum Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01333865 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS) — 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Memantine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS) |
6 | — |
| SECONDARY Number of Participants With Reduction in ASD Symptom Severity as Defined by the NIMH Clinical Global Impression for Pervasive Developmental Disorders (CGI-PDD) Improvement Score |
15 | — |
Summary
The main objective of this study is to evaluate the safety and effectiveness of memantine (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Eligibility Criteria
Inclusions
- Male and female outpatients 18-50 years of age.
- Participants must have DSM-IV-TR diagnosis of PDD and displaying PDD symptoms with at least moderate impairment (SRS score ≥ 85 and CGI-PDD ≥ 4).
- Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder (with the exception of a total lack of spoken language), Asperger's disorder, or PDD-NOS as established by clinical interview and confirmed by DICA-R PDD module.
- Subjects and/or their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Subjects and/or their legal representative must be considered reliable reporters.
- Each subject and/or their authorized legal representative must understand the nature of the study. The subject and/or their legal representative must sign an informed consent document.
- Subject must be able to participate in mandatory blood draws.
- Subject must be able to swallow pills.
- Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
Exclusions
- IQ 3 times ULN) and those with severely impaired renal function (eGFR < 30).
- Subjects with genitourinary conditions that raise urine pH (e.g., renal tubular acidosis, severe infection of the urinary tract).
- Uncorrected hypothyroidism or hyperthyroidism.
- Subjects with untreated and/or unstable diabetes.
- Non-febrile seizures without a clear and resolved etiology.
- Pregnant or nursing females.
- Known hypersensitivity to memantine.
- Severe allergies or multiple adverse drug reactions.
- A non-responder or history of intolerance to memantine, after treatment at adequate doses as determined by the clinician.
- Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
Data sourced from ClinicalTrials.gov (NCT01333865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.