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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: Completed Phase 3 study, sponsored by University of Medicine and Dentistry of New Jersey.

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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 20 participants
Start Date 2004-04
Est. Completion 2007-04
Phase Phase 3

What the finished NCT00252603 record still lists

NCT00252603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Galantamine is the first listed.

NCT00252603 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00252603's enrollment target sits among peer trials

20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00252603, the US trial registry maintained by the National Library of Medicine. NCT00252603 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.