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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 is currently in Phase 3 clinical development and has not been approved by the FDA. The drug has received Breakthrough Therapy, Orphan Drug, Fast Track, and Priority Review designations from the FDA.
DCCR is a small molecule that targets the hyperphagia and other symptoms associated with Prader-Willi Syndrome. Its mechanism of action involves modulating pathways related to appetite regulation and metabolic function, though the specific molecular target is not disclosed in the available information.
DCCR is being developed by Soleno Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SLNO. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with Prader-Willi Syndrome.
DCCR is currently in Phase 3 clinical development. It has completed two Phase 3 trials and has one active Phase 3 trial that is not yet recruiting. The drug is investigational and has not received FDA approval, though it has been granted several expedited development designations.
DCCR has been studied in three Phase 3 clinical trials. The completed trials are NCT03440814, a placebo-controlled study with 127 patients, and NCT03714373, an open-label extension with a randomized withdrawal period involving 115 patients. The active trial is NCT05701774, an open-label extension with 83 patients.
Yes, DCCR is also known as diazoxide choline. Clinical trials for DCCR in Prader-Willi Syndrome are titled as studies of diazoxide choline, and the drug is being evaluated under this name in Phase 3 trials conducted in the United States and the United Kingdom.