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NCT00252603 · ClinicalTrials.gov registry record · Phase 3
Galantamine Versus Placebo in Childhood Autism
A Phase 3 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT00252603 is a Phase 3 study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 20 participants.
The verdict
NCT00252603, a Phase 3 study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study 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. Galantamine will be superior to placebo in the acute treatment of global autism. 2. Galantamine will be superior to placebo in improving functional ability. 3. Galantamine will be superior to placebo in improving language function. 4. Galantamine will be superior to placebo improving irritable and hyperactive behavior. 5. Galantamine will be superior to placebo in improving social deficits.
Interventions
- DRUG Galantamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2004-04 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00252603
The ClinicalTrials.gov registry entry for NCT00252603 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Medicine and Dentistry of New Jersey, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Galantamine is the first listed.
NCT00252603 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00252603 about?
NCT00252603 is a clinical study titled "Galantamine Versus Placebo in Childhood Autism". 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 rep...
What is the current status of trial NCT00252603?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2004-04. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00252603?
The interventions under investigation include: Galantamine (DRUG).
Who is sponsoring clinical trial NCT00252603?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
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