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NCT02034071 · ClinicalTrials.gov registry record · Phase 1
Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome
A Phase 1 study of Prader-Willi Syndrome, sponsored by Essentialis.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT02034071: Completed Phase 1 study of Prader-Willi Syndrome, sponsored by Essentialis.
NCT02034071 is a Phase 1 study of Prader-Willi Syndrome that has completed, run by Essentialis. The registered enrollment target is 13 participants, below the 70-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02034071, a Phase 1 study of Prader-Willi Syndrome, has completed, sponsored by Essentialis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
• This is a single-center, open-label, single-arm study with a double-blind, placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of about 1.5 mg/kg (maximum starting dose of 145 mg) and are titrated every 14 days to about 2.4 mg/kg, 3.3 mg/kg, 4.2 mg/kg, and 5.1 mg/kg (maximum dose of 507.5 mg). These DCCR doses are equivalent to diazoxide doses of 1.03, 1.66, 2.28, 2.9, and 3.52 mg/kg. The administered dose will be as close to the mg/kg dosing as can be achieved by the available dose strengths of DCCR. Patients will be up-titrated at each visit at the discretion of the investigator. All patients will be continued in the double-blind, placebo-controlled, randomized withdrawal extension. Any patient who showed an increase in resting energy expenditure and/or a reduction in hyperphagia from Baseline through Day 55 or Day 69 will be designated a responder, whereas all others will be designated non-responders. Responders will be randomized in a 1:1 ratio either to continue on active treatment at the dose they were treated with on Day 69 or to the placebo equivalent of that dose for an additional 4 weeks. Non-responders will continue open label treatment during the extension.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DCCR
Study Locations (1)
California
- University of California, Irvine - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT02034071 record still lists
NCT02034071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 70-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Prader-Willi Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02034071 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02034071 about?
NCT02034071 is a clinical study titled "Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome". • This is a single-center, open-label, single-arm study with a double-blind, placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of about 1.5 mg/kg (maximum starting dose of 145 mg) and are titrated every 14 days to about 2.4 mg/kg, 3.3 mg/kg, 4.2 mg/kg, and 5....
What is the current status of trial NCT02034071?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2014-04. Estimated completion is 2015-05.
What conditions does trial NCT02034071 study?
This clinical trial studies the following conditions: Prader-Willi Syndrome.
What interventions are being tested in trial NCT02034071?
The interventions under investigation include: Placebo (DRUG), DCCR (DRUG).
Who is sponsoring clinical trial NCT02034071?
This trial is sponsored by Essentialis, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02034071 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02034071's enrollment target sits among peer trials
13 15th of 16 higher than 2 of 16 other Prader-Willi Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prader-Willi Syndrome 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.
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