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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 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.

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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

Prader-Willi Syndrome

Interventions

  • DRUG Placebo
  • DRUG DCCR

Study Locations (1)

California

  • University of California, Irvine - Orange

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2014-04
Est. Completion 2015-05
Phase Phase 1

Sponsor

Essentialis

4 total trials

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What the Registry Record Tells You About NCT02034071

The ClinicalTrials.gov registry entry for NCT02034071 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 70-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (81% lower). The listed sponsor is Essentialis, which has 4 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.