Status:
COMPLETED
Galantamine Versus Placebo in Childhood Autism
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Alliance for Autism Research
Conditions:
Autism
Childhood Autism
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
Autism is a severe neurodevelopmental disorder that affects up to 16 in 10,000 individuals. It is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behavior...
Detailed Description
Once enrolled in the study, subjects will receive evaluations and testing to determine if they meet the necessary criteria for admission into study treatment. Subjects will not be responsible for the ...
Eligibility Criteria
Inclusion
- Meets DSM-IV, ADI-R and ADOS-G criteria for autistic disorder
- Age 5-17 years
- Outpatients
- Parent or legal guardian willing to sign informed consent.
- Male or female patients
- Patient scores at least a "4" (moderately ill) on the Clinical Global Impression Scale for Autistic Disorder (CGI AD).
- Children who are minimally or non- verbal as indicated by a score of 50% of an 18 month old on the MacArthur Communicative Development Inventory
- Exclusion Criteria:
- Subjects with any of the following past or present mental disorders: psychotic disorders, mood disorders, including bipolar disorders.
- Subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).
- Subjects with active seizure disorder (seizures within the past six months).
- Subjects with clinically significant or unstable medical illness, including patients with current evidence of clinically significant hematopoietic, or cardiovascular disease.
- Subjects with present or history of the following:
- gastrointestinal, liver, kidney, or other known conditions which will presently interfere with the absorption, distribution, metabolism, or excretion of drugs,
- seizure disorders (active), cerebrovascular disease or brain trauma as etiology of autistic behavior,
- clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism or diabetes,
- recent history or presence of any form of malignancy.
- Subjects who report significant improvement of autism symptoms and behaviors to current medications or have only global autism ratings on the CGI of absent, minimal or mild severity, or who are more than minimally verbal.
- Subjects whose global autism ratings are assessed as being absent, minimal or mild.
- Treatment within the previous 30 days with any drug known to have a well-defined potential for toxicity to a major organ.
- Subjects with clinically significant abnormalities in laboratory tests or physical exam.
- Subjects likely to require any other psychotropic medication during the study, with the exception of clonidine for insomnia (started at least one month prior to entrance into the study), as well as anticonvulsants at a constant dose for stable seizure disorder or, unless otherwise permitted.
- Subjects unable to tolerate taper from psychoactive medication, if specified.
- Subjects with a history of hypersensitivity or severe side effects associated with the use of galantamine, or other acetylcholinesterase inhibitors.
- Subjects with a history of prior treatment with galantamine of 4mg/day for 6 weeks.
- Subjects who have received any of the following interventions within the prescribed period before starting treatment:
- investigational drugs within the previous 30 days.
- monoamine oxidase inhibitors within the previous fourteen days.
- long-acting phenothiazines within the previous six weeks.
- other psychotropic drugs within the previous seven days, unless otherwise permitted.
- Subjects with any organic or systemic disease or patients who require a therapeutic intervention, not otherwise specified, which would confound the evaluation of the safety of the study medication.
- Subjects who reside in a remote geographical area or who do not have regular access to transportation to the clinical facility.
- Gender
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00252603
Start Date
April 1 2004
End Date
April 1 2007
Last Update
January 29 2007
Active Locations (1)
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1
UMDNJ Robert Wood Johnson Medical School - Dept of Psychiatry
Piscataway, New Jersey, United States, 08854