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Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome

S

Soleno Therapeutics

Status and phase

Active, not recruiting
Phase 3

Conditions

Prader-Willi Syndrome

Treatments

Drug: DCCR

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.

Enrollment

83 estimated patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)

  2. Participant must:

    1. Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;
    2. Have participated in but discontinued from the Study C602 RW Period and at least 16 weeks have elapsed since the date of their randomization into the C602 RW Period; or
    3. Have participated in Study C602 OLE period, did not consent to participate in the RW Period, and at least 16 weeks have elapsed since the date of their C602 Open-Label Extension End of Treatment Visit.

Exclusion criteria

  1. Positive urine pregnancy test (in females of child-bearing potential)
  2. Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.
  3. Participation in a clinical study of an investigational drug (including approved drugs for unapproved uses), investigational device, or therapeutic intervention subsequent to the C602 Open-Label Extension End of Treatment Visit.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

83 participants in 1 patient group

DCCR
Experimental group
Description:
75 - 525 mg DCCR
Treatment:
Drug: DCCR

Trial contacts and locations

22

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Central trial contact

C614 Project Manager

Data sourced from clinicaltrials.gov

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