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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01333865
First received: November 19, 2010
Last updated: March 24, 2014
Last verified: March 2014

November 19, 2010
March 24, 2014
January 2010
January 2014   (final data collection date for primary outcome measure)
Reduction in ASD symptom severity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Reduction in ASD symptom severity is defined as a reduction in Social Responsiveness Scale (SRS) score from baseline of greater than or equal to 30% and an NIMH Clinical Global Impression (CGI) Pervasive Developmental Disorder (PDD) Improvement score less than or equal to 2.
Same as current
Complete list of historical versions of study NCT01333865 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders

The main objective of this study is to evaluate the safety and effectiveness of memantine (Namenda®) for cognitive and behavioral impairment in adults ages 18-45 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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autism Spectrum Disorders
Drug: Memantine

We plan for 20 adults with ASD to sign consent to expose 10 subjects to the study medication. 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.

Other Name: Namenda
Experimental: Memantine (Namenda) Treatment
Intervention: Drug: Memantine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
Not Provided
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01333865
2010-P-000016
No
Gagan Joshi, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP