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Also known as DCCR (diazoxide choline) extended-release tablets
DCCR · 3 trials · 1 indication
Assess the safety of DCCR by evaluating the incidence and severity of adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. Adverse events will be described by type and level of severity.
Safety analyses will be conducted in all participants who receive at least one dose of DCCR. Adverse events will be described by type and level of severity.
Hyperphagia-related behaviors will be assessed by the hyperphagia questionnaire for clinical trials (HQ-CT), an instrument designed to measure symptoms of food related preoccupations and behaviors. The HQ-CT consists of nine items with responses ranging from 0-4 (best to worst). Scores from 9 items will be summed for a possible total score range of 0-36.
Hyperphagia-related behaviors were assessed by the validated hyperphagia questionnaire for clinical trials (HQ-CT), an instrument designed to measure symptoms of food related preoccupations and behaviors that was completed by the caregiver. The HQ-CT consists of nine items with responses ranging from 0-4 units each (possible total score range: 0-36). The HQ-CT was assessed at Screening, Baseline (Visit 2), and approximately every 4 weeks post-dose at Week 4, Week 8, and Week 13. A decrease in score from baseline represented improvement.
| Arm | Type | Description |
|---|---|---|
| DCCR | EXPERIMENTAL | 75 - 525 mg DCCR |
| OLE DCCR | EXPERIMENTAL | 75 - 525 mg DCCR |
| RW DCCR | EXPERIMENTAL | 75 - 525 mg DCCR |
| RW Placebo | PLACEBO_COMPARATOR | 75 - 525 mg Placebo for DCCR |
| Placebo | PLACEBO_COMPARATOR | 75 - 450 mg placebo for DCCR |
| Name | Type | Description |
|---|---|---|
| DCCR | DRUG | Once daily oral administration |
| Placebo for DCCR | DRUG | Once daily oral administration of double-blind (placebo for DCCR) tablet(s) during the RW Period |
Inclusion Criteria: 1. Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate) 2. Participant must: 1. Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period; 2. Have par...
DCCR is an investigational small molecule being developed for the treatment of Prader-Willi Syndrome, a rare genetic disorder. It has been studied in Phase 3 clinical trials in patients with PWS, including pediatric and adult patients aged 4 years and older. It is not yet approved for commercial use.
DCCR is being developed by Soleno Therapeutics, Inc., which trades under the ticker SLNO. The company has advanced DCCR through Phase 3 clinical development for Prader-Willi Syndrome and has received multiple FDA designations for the program, including Breakthrough Therapy, Fast Track, Priority Review, and Orphan Drug.
DCCR has completed Phase 3 clinical development for Prader-Willi Syndrome. Three Phase 3 trials have been completed, and no trials are currently active. The program has received FDA designations including Breakthrough Therapy, Priority Review, Fast Track, and Orphan Drug, though DCCR remains an investigational therapy.
DCCR has been evaluated in three completed Phase 3 trials: NCT03440814, a study of diazoxide choline in patients with Prader-Willi Syndrome; NCT03714373, an open-label extension followed by a double-blind, placebo-controlled randomized withdrawal period; and NCT05701774, an open-label extension study. Together these trials enrolled 319 patients in the United States and United Kingdom.
Yes, DCCR is diazoxide choline, a small molecule. The Phase 3 trial NCT03440814 is titled as a study of diazoxide choline in patients with Prader-Willi Syndrome, confirming that DCCR and diazoxide choline refer to the same investigational compound being developed by Soleno Therapeutics.
DCCR was studied in three completed Phase 3 trials that were randomized, double-blind, and placebo-controlled, with a total enrollment of 319 patients. The trials enrolled patients aged 4 years and older with Prader-Willi Syndrome across sites in the United States and United Kingdom, and included open-label extension periods.