Prader-Willi SyndromePhase 3NCT04086810
An Open-Label Study of DCCR Tablet in Patients With PWS
A Phase 3 study testing DCCR in people with Prader-Willi Syndrome, run by Soleno Therapeutics, Inc..
Trial summary
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- DCCR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Oct 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
- Conditions
- Prader-Willi Syndrome
- Being tested
- DCCR
- Keywords
- PWS, Prader-Willi Syndrome
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCCRDrug
Once daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| DCCR | Experimental | 25 - 450 mg DCCR Receives: Drug: DCCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (Safety)
Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.
Measured: Baseline to Week 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: Study was never initiated; rather the duration of open-label study C602 (NCT03714373) was extended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soleno Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086810
- Sponsor's protocol ID
- C603
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT04086810
- Acronym / sponsor ID
- C603
- Conditions
- Prader-Willi Syndrome
- Keywords
- PWS, Prader-Willi Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated; rather the duration of open-label study C602 (NCT03714373) was extended.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Soleno Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCCR | Experimental | Drug: DCCR25 - 450 mg DCCR |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCCROnce daily oral administration | Drug | DCCR |
Primary outcome
Adverse Events (Safety)
Time frame: Baseline to Week 106
Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DCCR in people with Prader-Willi Syndrome, run by Soleno Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (Safety) (time frame: Baseline to Week 106). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.