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Memantine in Adult Autism Spectrum Disorder

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Johns Hopkins University

Status

Terminated

Conditions

Asperger's Disorder
Pervasive Developmental Disorder NOS
Autism

Treatments

Drug: memantine
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01078844
NA_00015760

Details and patient eligibility

About

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).

Enrollment

4 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC)

  • Participant has a diagnosis of:

    • Autistic Disorder
    • Asperger's Disorder
    • Pervasive Developmental Disorder (PDD) NOS
  • 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):

  • Active seizures (Patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible).
  • Rett's Syndrome or Childhood Disintegrative Disorder
  • Active treatment with an acetylcholinesterase inhibitor
  • Prior or current treatment with memantine
  • Current treatment with lamotrigine
  • Genetic, metabolic or degenerative disorder (excepting Fragile X).
  • Brain malformation or known severe brain trauma
  • Pregnancy or breastfeeding
  • Glomerular Filtration Rate (GFR) < 30 mL/min

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

4 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Treatment as usual plus placebo
Treatment:
Drug: Placebo
memantine
Active Comparator group
Description:
Treatment as usual plus memantine
Treatment:
Drug: memantine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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