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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
EUCTR2018-004215-50-GB |
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Date of registration:
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12/08/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A study to evaluate the effects of a medicine named diazoxide choline in patients with the genetic disorder Prader-Willi syndrome.
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients with Prader-Willi Syndrome |
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Date of first enrolment:
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23/04/2019 |
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Target sample size:
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105 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004215-50 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trial Information
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Address:
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43 High Street
SL7 1BA
Marlow
United Kingdom |
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Telephone:
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441628876432 |
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Email:
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C601ProjectManager@soleno.life |
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Affiliation:
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Soleno Therapeutics UK Limited |
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Name:
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Clinical Trial Information
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Address:
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43 High Street
SL7 1BA
Marlow
United Kingdom |
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Telephone:
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441628876432 |
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Email:
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C601ProjectManager@soleno.life |
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Affiliation:
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Soleno Therapeutics UK Limited |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
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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
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Intervention(s)
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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
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Primary Outcome(s)
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Primary end point(s): Hyperphagia (HQ-CT) change from Baseline (Visit 2) to Visit 7
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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.
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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.
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Timepoint(s) of evaluation of this end point: Visit 2 (baseline) to Visit 7
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Secondary Outcome(s)
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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
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Timepoint(s) of evaluation of this end point: Visit 7
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Secondary ID(s)
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NCT03440814
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C601
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Source(s) of Monetary Support
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Soleno Therapeutics, Inc.
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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