Galantamine Versus Placebo in Childhood Autism

NCT00252603 | Completed Phase 3

• 1 other identifier: 4682
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 behaviors characterized by stereotypic complex hand and body movements, craving for sameness, and narrow repetitive interests. Autism severely impacts both the affected individual and family members. The proposed study is designed to assess the efficacy of treatment with Galantamine vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. We therefore hypothesize:

1. 1.Galantamine will be superior to placebo in the acute treatment of global autism.
2. 2.Galantamine will be superior to placebo in improving functional ability.
3. 3.Galantamine will be superior to placebo in improving language function.
4. 4.Galantamine will be superior to placebo improving irritable and hyperactive behavior.
5. 5.Galantamine will be superior to placebo in improving social deficits.

Conditions

Autism; Childhood Autism

Keywords

Autism; Childhood Autism

Outcome Measures

Primary Outcomes (6)

• Autism Diagnostic Observation Schedule-Generic (ADOS-G)- Change from Baseline to Final Visit

• Clinical Global Impression Improvement (CGI)- Change from Baseline to Final Visit

• Aberrant Behavior Checklist (ABC) (hyperactivity/irritability sections)- Change from Baseline to Final Visit

• Vineland Adaptive Behavior Scale- Change from Baseline to Final Visit

• MacArthur Communicative Development Inventory (MCDI)- Change from Baseline to Final Visit

• Conners' Parent Rating Scale-Revised: Long form (CPRS-R:L)- Change from Baseline to Final Visit

Interventions

Galantamine DRUG

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Alliance for Autism Research: collaborator

Study Sites (1)

UMDNJ Robert Wood Johnson Medical School - Dept of Psychiatry

Piscataway, New Jersey, 08854, United States

Location

Related Publications (18)

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  BACKGROUND

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  PMID: 2255260 BACKGROUND

• Woodruff-Pak DS, Vogel RW 3rd, Wenk GL. Galantamine: effect on nicotinic receptor binding, acetylcholinesterase inhibition, and learning. Proc Natl Acad Sci U S A. 2001 Feb 13;98(4):2089-94. doi: 10.1073/pnas.98.4.2089. Epub 2001 Feb 6.

  PMID: 11172080 BACKGROUND

• Ure A, Cox GR, Haslam R, Williams K. Acetylcholinesterase inhibitors for autistic spectrum disorders. Cochrane Database Syst Rev. 2023 Jun 1;6(6):CD013851. doi: 10.1002/14651858.CD013851.pub2.

  PMID: 37267443 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sherie Novotny, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: April 1, 2004
• Study Completion: April 1, 2007
• Last Updated: January 29, 2007

Record last verified: 2007-01

Locations

US (1)