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NCT01525901 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01525901 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 19 participants.
The verdict
NCT01525901, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1) treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene deficiency in order to evaluate safety, tolerability, and efficacy. IGF-1 is an injection under the skin that contains human IGF-1. IGF-1 is approved by the FDA under the brand name Increlex for the treatment of children with short stature due to primary IGF-1 deficiency. It is being used off-label in the current study and is not FDA approved, nor has it yet been studied in humans for the treatment of SHANK3 deficiency.
Interventions
- DRUG Normal saline
- DRUG Insulin-Like Growth Factor-1 (IGF-1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-08-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01525901
The ClinicalTrials.gov registry entry for NCT01525901 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 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 Normal saline is the first listed.
NCT01525901 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01525901 about?
NCT01525901 is a clinical study titled "Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)". The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1) treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene deficiency in order to evaluate safety, tolerability, and efficacy. IGF-1 is an injection under the skin that contains human IGF...
What is the current status of trial NCT01525901?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2012-02. Estimated completion is 2016-08-23.
What interventions are being tested in trial NCT01525901?
The interventions under investigation include: Normal saline (DRUG), Insulin-Like Growth Factor-1 (IGF-1) (DRUG).
Who is sponsoring clinical trial NCT01525901?
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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