An Open-Label Study of DCCR Tablet in Patients With PWS | NCT04086810

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

NCT04086810

Sponsor

Soleno Therapeutics, Inc.

Status

Withdrawn

Last Update Posted

Aug 3, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Prader-Willi Syndrome

Interventions

DCCR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was never initiated; rather the duration of open-label study C602 (NCT03714373) was extended.

Expanded Access Info

Start Date

Oct 2019Estimated

Primary Completion Date

Oct 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Sep 10, 2019

First Submission Date that Met QC Criteria

Sep 11, 2019

First Posted Date

Sep 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2021

Last Update Posted Date

Aug 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DCCR	Experimental	25 - 450 mg DCCR	Drug: DCCR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DCCR	Drug	Once daily oral administration	DCCR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events (Safety)	Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.	Baseline to Week 106

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011218	Prader-Willi Syndrome

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided