193. Prader-Willi syndrome Clinical trials / Disease details
Clinical trials : 113 / Drugs : 111 - (DrugBank : 26) / Drug target genes : 48 - Drug target pathways : 102
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05701774 (ClinicalTrials.gov) | January 31, 2023 | 18/1/2023 | Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome | An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: DCCR | Soleno Therapeutics, Inc. | NULL | Not yet recruiting | 4 Years | N/A | All | 83 | Phase 3 | NULL |
| 2 | NCT04086810 (ClinicalTrials.gov) | October 2019 | 10/9/2019 | An Open-Label Study of DCCR Tablet in Patients With PWS | An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: DCCR | Soleno Therapeutics, Inc. | NULL | Withdrawn | 4 Years | N/A | All | 0 | Phase 3 | NULL |
| 3 | EUCTR2018-004216-22-GB (EUCTR) | 25/09/2019 | 27/06/2019 | A study to determine the safety of the study drug Diazoxide Choline Controlled-Release Tablet after being given for a long time to patients with the genetic disorder Prader-Willi Syndrome. | An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome | Hyperphagia associated with Prader-Willi Syndrome (PWS) MedDRA version: 20.0;Level: PT;Classification code 10020710;Term: Hyperphagia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: diazoxide choline Product Code: DCCR INN or Proposed INN: Diazoxide choline Other descriptive name: DIAZOXIDE CHOLINE | Soleno Therapeutics UK Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;United Kingdom | ||
| 4 | EUCTR2018-004215-50-GB (EUCTR) | 23/04/2019 | 12/08/2019 | A study to evaluate the effects of a medicine named diazoxide choline in patients with the genetic disorder Prader-Willi syndrome. | A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients with Prader-Willi Syndrome | Hyperphagia associated with Prader-Willi Syndrome. MedDRA version: 20.0;Level: PT;Classification code 10020710;Term: Hyperphagia;System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: diazoxide choline Product Code: DCCR INN or Proposed INN: Diazoxide choline Other descriptive name: DIAZOXIDE CHOLINE | Soleno Therapeutics UK Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;United Kingdom | ||
| 5 | NCT03714373 (ClinicalTrials.gov) | October 1, 2018 | 27/9/2018 | Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period | An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Extended-Release Tablets in Participants With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period | Prader-Willi Syndrome | Drug: DCCR;Drug: Placebo for DCCR | Soleno Therapeutics, Inc. | NULL | Active, not recruiting | 4 Years | N/A | All | 115 | Phase 3 | United States;United Kingdom |
| 6 | NCT03440814 (ClinicalTrials.gov) | May 9, 2018 | 13/2/2018 | A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome | A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: DCCR;Drug: Placebo for DCCR | Soleno Therapeutics, Inc. | NULL | Completed | 4 Years | N/A | All | 127 | Phase 3 | United States;United Kingdom |
| 7 | NCT02893618 (ClinicalTrials.gov) | July 2017 | 30/8/2016 | A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR) | A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR) | Prader-Willi Syndrome | Drug: Diazoxide choline controlled-release tablet | Essentialis, Inc. | NULL | Not yet recruiting | 18 Years | 65 Years | Both | 32 | Phase 2 | NULL |
| 8 | NCT02034071 (ClinicalTrials.gov) | April 2014 | 8/1/2014 | Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome | A Dose Titration Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal Extension | Prader-Willi Syndrome | Drug: DCCR;Drug: Placebo | Essentialis, Inc. | NULL | Completed | 10 Years | 22 Years | Both | 13 | Phase 1/Phase 2 | United States |