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Efficacy and Safety Trial of Sodium Valproate, in Paediatric and Adult Patients With Wolfram Syndrome
This trial aims to investigate the efficacy, safety and tolerability of sodium valproate in the treatment of patients with Wolfram syndrome. 70 paediatric and adult patients were initially planned to be randomised 2:1 to receive either sodium valproate or placebo at 6 international centres. 63 patients were recruited when a decision was made to stop the study recruitment in November 2022.
Details
| Lead sponsor | University of Birmingham |
|---|---|
| Phase | PHASE2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 63 |
| Start date | Fri Dec 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Wolfram Syndrome
Interventions
- Sodium Valproate 200Mg E/C Tablet
- Sodium Valproate matched placebo
Countries
France, United Kingdom, Spain, Poland