A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders

Autism Spectrum Disorders Clinical Trial

Official title:

A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01333865
• Other study ID #: 2010-P-000016
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 19, 2010
• Last updated: September 30, 2014
• Start date: January 2010

Study information

• Verified date: September 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 < 85.

• Total lack of spoken language.

• DSM-IV-TR PDD diagnoses of Rett's disorder, or childhood disintegrative disorder.

• Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.

• Active symptoms of anorexia or bulimia nervosa

• Current diagnosis of a psychotic disorder or unstable bipolar disorder.

• History of recent or current (past 30 days) clinically significant depressive or anxiety disorder that warrants treatment.

• Current diagnosis of schizophrenia.

• History of substance use (except nicotine or caffeine) within past 3 months

• Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.

• Subjects with severe hepatic impairment (LFTs > 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Drug:
• Memantine
Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD. During the 12 weeks of study duration, subjects will be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine will be administered in divided dose twice a day in the morning and evening. Titration of study medication will be guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects will be evaluated.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)	Number of participants with reduction in ASD symptom severity defined as a reduction in Social Responsiveness Scale (SRS) score from baseline of greater than or equal to 30%.; The SRS is a 65-item rating scale completed by an informant to measure the severity of autism spectrum symptoms as they occur in natural settings.	Week 12	No
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	Number of participants with reduction in ASD symptom severity defined as an NIMH Clinical Global Impression (CGI) Pervasive Developmental Disorder (PDD) Improvement score less than or equal to 2. The CGI-Improvement is a clinician-rated measure of improvement. Scores range from 1 (very much improved) to 7 (very much worse) for PDD.	Pre-treatment - 12 weeks	No