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DCCR for Prader-Willi Syndrome

Phase 3

Waitlist Available

Research Sponsored by Soleno Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of ole (up to 4 years)

Awards & highlights

Study Summary

This trial is testing the long-term safety of a drug for Prader-Willi syndrome. Subjects can stay in the trial for up to 3 years.

Eligible Conditions

Prader-Willi Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of ole (up to 4 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of ole (up to 4 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of ole (up to 4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from RW Period Baseline in HQ-CT Total Score

Secondary outcome measures

Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported

Change from Baseline in HQ-CT Total Score

Change in Body Fat Mass

+2 more

Side effects data

From 2020 Phase 3 trial • 127 Patients • NCT03440814

36%

Hypertrichosis

19%

Oedema peripheral

12%

Hyperglycaemia

11%

Upper respiratory tract infection

Hirsutism

Blood glucose increased

Pyrexia

Headache

Pneumonia

Abnormal behaviour

Respiratory failure

Aggression

Erythema multiforme

Pulmonary oedema

Diarrhoea

Abdominal pain

Staphylococcal infection

Lower respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

DCCR

Placebo for DCCR

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: RW DCCRExperimental Treatment1 Intervention

75 - 525 mg DCCR

Group II: OLE DCCRExperimental Treatment1 Intervention

75 - 525 mg DCCR

Group III: RW PlaceboPlacebo Group1 Intervention

75 - 525 mg Placebo for DCCR

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DCCR

2014

Completed Phase 3

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Soleno Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

345 Total Patients Enrolled

4 Trials studying Prader-Willi Syndrome

315 Patients Enrolled for Prader-Willi Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the DCCR drug been given the green light by the FDA?

"DCCR has been Phase 3 trialed, meaning that while there is data supporting its efficacy, there are also multiple rounds of safety data. Therefore, our team rates it a 3 on the Power scale."

Answered by AI

Are there any participants still needed for this clinical trial?

"Unfortunately, this particular study is not enrolling patients at the moment. It was first made public on October 1st 2018 and has had its most recent update on June 2nd, 2022. There are other trials with open recruitment at 1451 different locations though."

Answered by AI

Are there many different locations in Canada where this research project is taking place?

"There are 20+ study locations, but a few notable ones include University Hospitals Cleveland Medical Center in Ohio, The Research Institute at Nationwide Children's Hospital in Florida, and University of Florida Gainesville in Maryland."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period

2018. "Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03714373.