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OpenTrials
Active, Not Recruiting

NCT Number: NCT05701774

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fulbourn Hospital, Cambridge, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
  • Participant must:
  • Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;
  • 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
  • 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

  • Positive urine pregnancy test (in females of child-bearing potential)
  • Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.
  • 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.

Treatment and study plan

DCCR

Drug

Once daily oral administration

Primary outcomes

  1. Safety of DCCR (adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. ( Adverse events)

    Time frame: Baseline to End of Study or until resolution of certain adverse events

    Assess the safety of DCCR by evaluating the incidence and severity of adverse events.

    Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. Adverse events will be described by type and level of severity.

Sponsors and collaborators

Lead sponsor

Soleno Therapeutics, Inc.

Industry

Registry information

Official study title

An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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