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NCT01970345 · ClinicalTrials.gov registry record · Phase 2
A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01970345 is a Phase 2 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 3 participants.
The verdict
NCT01970345, a Phase 2 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, and repetitive behaviors. We expect to provide evidence for the safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on secondary outcomes of social impairment, language delay, and repetitive behavior, as well as on functional outcomes of global severity.
Interventions
- DRUG IGF-1
- DRUG Placebo/saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-09-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01970345
The ClinicalTrials.gov registry entry for NCT01970345 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IGF-1 is the first listed.
NCT01970345 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01970345 about?
NCT01970345 is a clinical study titled "A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder". The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, a...
What is the current status of trial NCT01970345?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2014-05. Estimated completion is 2017-09-13.
What interventions are being tested in trial NCT01970345?
The interventions under investigation include: IGF-1 (DRUG), Placebo/saline (DRUG).
Who is sponsoring clinical trial NCT01970345?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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