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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 10 December 2019
Main ID:  EUCTR2018-004215-50-GB
Date of registration: 12/08/2019
Prospective Registration: No
Primary sponsor: Soleno Therapeutics UK Ltd.
Public title: A study to evaluate the effects of a medicine named diazoxide choline in patients with the genetic disorder Prader-Willi syndrome.
Scientific title: A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients with Prader-Willi Syndrome
Date of first enrolment: 23/04/2019
Target sample size: 105
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004215-50
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
United Kingdom United States
Contacts
Name: Clinical Trial Information   
Address:  43 High Street SL7 1BA Marlow United Kingdom
Telephone: 441628876432
Email: C601ProjectManager@soleno.life
Affiliation:  Soleno Therapeutics UK Limited
Name: Clinical Trial Information   
Address:  43 High Street SL7 1BA Marlow United Kingdom
Telephone: 441628876432
Email: C601ProjectManager@soleno.life
Affiliation:  Soleno Therapeutics UK Limited
Key inclusion & exclusion criteria
Inclusion criteria:
The following are considered to be the Principal Inclusion Criteria for Study C601. The full list of study inclusion criteria is included in the study protocol.
a/. Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subjects, as appropriate),
b/. Male and female subjects, 4 years of age and older
c/. Genetically-confirmed Prader-Willi syndrome and have hyperphagia
d/. In a stable care setting for at least 6 months prior to Visit 1.
e/. Caregiver must have been caring for the subject for at least 6 months prior to Visit 1.
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 C601. The full list of study exclusion criteria is included in the study protocol.

- Weight < 20 kg or = 135 kg
- Have participated in an interventional clinical study (i.e., investigational drug or device, approved drugs or device evaluated for unapproved use) within 60 days prior to Visit 1
- 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 90 days after study participation
- Any other known disease and/or condition, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Hyperphagia associated with Prader-Willi Syndrome.
MedDRA version: 20.0 Level: PT Classification code 10020710 Term: Hyperphagia System Organ Class: 10027433 - Metabolism and nutrition disorders
Intervention(s)

Product Name: diazoxide choline
Product Code: DCCR
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Diazoxide choline
CAS Number: 1098065-76-9
Current Sponsor code: DCCR
Other descriptive name: DIAZOXIDE CHOLINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 25-150
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: The primary objective of this study is to evaluate the effects of diazoxide choline controlled-release (DCCR) tablet compared to placebo on hyperphagia in Prader-Willi syndrome (PWS) patients.
Timepoint(s) of evaluation of this end point: Visit 2 (baseline) to Visit 7
Primary end point(s): Hyperphagia (HQ-CT) change from Baseline (Visit 2) to Visit 7
Secondary Objective: The secondary objectives of this study are to evaluate changes in body fat mass, Clinical Global Impression of Improvement (CGI-I), and Caregiver Global Impression of Change (GI-C) with DCCR compared to placebo in PWS patients.
Secondary Outcome(s)

Secondary end point(s): Body fat mass (DXA) change from Baseline to Visit 7
Clinical Global Impression of Improvement at Visit 7
Caregiver Global Impression of Change at Visit 7
Timepoint(s) of evaluation of this end point: Visit 7
Secondary ID(s)
C601
NCT03440814
Source(s) of Monetary Support
Soleno Therapeutics, Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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