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NCT01777542 · ClinicalTrials.gov registry record · Phase 2
Treatment of Rett Syndrome With Recombinant Human IGF-1
A Phase 2 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01777542: Completed Phase 2 study, sponsored by Boston Children's Hospital.
NCT01777542 is a Phase 2 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01777542, a Phase 2 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Investigators are recruiting children for a clinical trial using the medication recombinant human IGF-1 (a.k.a. mecasermin or INCRELEX) to see if it improves the health of children with Rett syndrome (RTT). While IGF-1 is approved by the Food \& Drug Administration (FDA) for certain use in children, it is considered an investigational drug in this trial because it has not previously been used to treat RTT. Information from this study will help determine if IGF-1 effectively treats RTT but will not necessarily lead to FDA approval of IGF-1 as a treatment for RTT.
Primary Outcome
The RSBQ is an informant/parent-completed measure of abnormal behaviors typically observed in individuals with RTT, which is completed by a parent/caregiver/LAR. Each item, grouped into eight domains/factors: General mood, Breathing problems, Body rocking and expressionless face, Hand behaviors, Repetitive face movements, Night-time behaviors, Fear/anxiety and Walking/standing), is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of "0"
Interventions
- DRUG Placebo
- DRUG Recombinant Human Insulin Growth Factor 1 (rhIGF-1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
What the finished NCT01777542 record still lists
NCT01777542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01777542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01777542 about?
NCT01777542 is a clinical study titled "Treatment of Rett Syndrome With Recombinant Human IGF-1". Investigators are recruiting children for a clinical trial using the medication recombinant human IGF-1 (a.k.a. mecasermin or INCRELEX) to see if it improves the health of children with Rett syndrome (RTT). While IGF-1 is approved by the Food \& Drug Administration (FDA) for certain use in children,...
What is the current status of trial NCT01777542?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2013-01. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01777542?
The interventions under investigation include: Placebo (DRUG), Recombinant Human Insulin Growth Factor 1 (rhIGF-1) (DRUG).
Who is sponsoring clinical trial NCT01777542?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01777542's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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