A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome

S

Soleno Therapeutics

Status and phase

Completed
Phase 3

Conditions

Prader-Willi Syndrome

Treatments

Drug: DCCR
Drug: Placebo for DCCR

Study type

Interventional

Funder types

Industry

Identifiers

NCT03440814
C601

Details and patient eligibility

About

The purpose of this is study is to evaluate the effects of DCCR (diazoxide choline controlled release tablets) in children and adults with Prader-Willi syndrome.

Enrollment

127 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (patients, as appropriate)
  • Genetically-confirmed Prader-Willi syndrome and hyperphagic
  • In a stable care setting for at least 6 months prior to Visit 1
  • Caregiver must have been caring for the patient for at least 6 months prior to Visit 1

Exclusion criteria

  • Have participated in an interventional clinical study (i.e., investigational drug or device, approved drugs or device evaluated for unapproved use) within prior 3 months
  • Positive urine pregnancy test (in females of child-bearing potential) or females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation
  • Any other known disease and/or condition, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

127 participants in 2 patient groups, including a placebo group

DCCR
Experimental group
Description:
75 - 450 mg DCCR
Treatment:
Drug: DCCR
Placebo
Placebo Comparator group
Description:
75 - 450 mg placebo for DCCR
Treatment:
Drug: Placebo for DCCR

Trial documents
1

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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