A study to determine the safety of the study drug Diazoxide Choline Controlled-Release Tablet after being given for a long time to patients with the genetic disorder Prader-Willi Syndrome.

Phase 1

• Conditions: Hyperphagia associated with Prader-Willi Syndrome (PWS); MedDRA version: 20.0Level: PTClassification code 10020710Term: HyperphagiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2018-004216-22-GB
• Lead Sponsor: Soleno Therapeutics UK Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-27
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

The following are considered to be the Principal Inclusion Criteria for Study C602:
1) Successful completion of clinical study C601;
2) Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate);
3) Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following are considered to be the Principal Exclusion Criteria for Study C602. Participants cannot enter C602 if not completed C601:
1) Anticipated requirement for use at any time during the study of the following prohibited medications:
• Anti-obesity medications or other medications (including herbal preparations, over-the-counter products) or procedures for weight reduction;
• Medications, including homeopathy and herbal preparations, that are strong inhibitors or inducers of CYP450 1A2 or 3A4 (Refer to http://medicine.iupui.edu/CLINPHARM/ddis/clinical-table, Flockhart Table);
• Medications known to prolong the QTc interval (Refer to QT Drugs List on https://crediblemeds.org/healthcare-providers/), except citalopram and escitalopram;
• Systemic steroids (i.e., oral, IM, or IV) for > 7 days;
• Any drugs medications, herbal preparation, homeopathy, nutraceuticals, or procedures (i.e., acupuncture, vagal stimulation), that may have an effect on safety endpoints;
• Use of any investigational drugs or devices;
2) Positive urine pregnancy test (in females of childbearing potential);
3) Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation;
4) Any new disease, condition, or circumstance, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol (e.g., an anticipated change of care setting);
5) New history in a first degree relative since the subject enrolled in clinical study C601 or a change in the subject’s physical examination that, in the opinion of the investigator, significantly increases the subject’s risk for thromboembolic event (e.g., venous thrombosis, pulmonary embolism, etc.).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified