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An Open-Label Study of DCCR Tablet in Patients With PWS

Primary Purpose

Prader-Willi Syndrome

Status
Withdrawn
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 focused on measuring PWS, Prader-Willi Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • Successful completion of clinical study C602, Visit 15
  • Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate)
  • Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.

Exclusion Criteria:

  • Positive urine pregnancy test (in females of childbearing 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 new disease, condition, or circumstance, which may significantly impact subject safety

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DCCR

    Arm Description

    25 - 450 mg DCCR

    Outcomes

    Primary Outcome Measures

    Adverse Events (Safety)
    Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 10, 2019
    Last Updated
    July 29, 2021
    Sponsor
    Soleno Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04086810
    Brief Title
    An Open-Label Study of DCCR Tablet in Patients With PWS
    Official Title
    An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was never initiated; rather the duration of open-label study C602 (NCT03714373) was extended.
    Study Start Date
    October 2019 (Anticipated)
    Primary Completion Date
    October 2019 (Anticipated)
    Study Completion Date
    October 2019 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prader-Willi Syndrome
    Keywords
    PWS, 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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DCCR
    Arm Type
    Experimental
    Arm Description
    25 - 450 mg DCCR
    Intervention Type
    Drug
    Intervention Name(s)
    DCCR
    Intervention Description
    Once daily oral administration
    Primary Outcome Measure Information:
    Title
    Adverse Events (Safety)
    Description
    Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.
    Time Frame
    Baseline to Week 106

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Successful completion of clinical study C602, Visit 15 Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate) Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires. Exclusion Criteria: Positive urine pregnancy test (in females of childbearing 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 new disease, condition, or circumstance, which may significantly impact subject safety

    12. IPD Sharing Statement

    Learn more about this trial

    An Open-Label Study of DCCR Tablet in Patients With PWS

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