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

Primary Purpose

Prader-Willi Syndrome

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DCCR
Sponsored by
Soleno Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prader-Willi Syndrome

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DCCR

    Arm Description

    75 - 525 mg DCCR

    Outcomes

    Primary Outcome Measures

    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)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2023
    Last Updated
    January 26, 2023
    Sponsor
    Soleno Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05701774
    Brief Title
    Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
    Official Title
    An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 31, 2023 (Anticipated)
    Primary Completion Date
    June 2028 (Anticipated)
    Study Completion Date
    June 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Soleno Therapeutics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prader-Willi Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    83 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DCCR
    Arm Type
    Experimental
    Arm Description
    75 - 525 mg DCCR
    Intervention Type
    Drug
    Intervention Name(s)
    DCCR
    Intervention Description
    Once daily oral administration
    Primary Outcome Measure Information:
    Title
    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)
    Description
    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.
    Time Frame
    Baseline to Week 262 or until resolution of certain adverse events

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    C614 Project Manager
    Phone
    650 353 2051
    Email
    C614ProjectManager@soleno.life

    12. IPD Sharing Statement

    Learn more about this trial

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

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