NCT04940572 (AUDIOWOLF) is a Phase 2 clinical trial of Depakine in Wolfram Syndrome, sponsored by Centre d'Etude des Cellules Souches.

Who is sponsoring NCT04940572?

NCT04940572 is sponsored by Centre d'Etude des Cellules Souches.

What drugs are being tested in NCT04940572?

Interventions in NCT04940572: Depakine.

What condition does NCT04940572 study?

NCT04940572 studies Wolfram Syndrome.

Is NCT04940572 still recruiting?

NCT04940572 is currently status unknown. Last updated 28 November 2023.

Last reviewed 2023-11-28 · How we verify

NCT04940572: AUDIOWOLF

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy Study of Daily Administration of VPA in Patients Affected by Wolfram Syndrome

Status unknown Phase 2 Last updated 28 November 2023

What this trial tests

Phase 2 trial testing Depakine in Wolfram Syndrome in 23 participants. Status unknown.

Timeline

26 November 2021

Primary endpoint
1 November 2025

1 December 2025

Quick facts

Lead sponsor	Centre d'Etude des Cellules Souches
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	26 November 2021
Primary completion	1 November 2025
Estimated completion	1 December 2025
Sites	2 locations across France, Spain

Drugs / interventions tested

Depakine — full drug profile →

Conditions studied

Wolfram Syndrome — all drugs for Wolfram Syndrome →

Sponsor

Centre d'Etude des Cellules Souches — full company profile →

Who can join

13 and older, any sex, with Wolfram Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Open label, phase II study non randomized single group assignment of 20 evaluable patients 13 years and older, over 37,5 kg body-weight, with sensorineural hearing loss of at least 20 dB at 8 kHz in high frequency average (HFA), and with documented genetic mutations in the WFS1 gene and with at least one other major documented clinical symptom pertaining to Wolfram syndrome (i.e. diabetes mellitus, diabetes insipidus, optic atrophy). Every patients will receive over three years a treatment by VPA (Depakine chrono).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Current Drug Repurposing Strategies for Rare Neurodegenerative Disorders.
Shah S, Dooms MM, Amaral-Garcia S, Igoillo-Esteve M. · · 2021 · cited 32× · PMID 34992533 · DOI 10.3389/fphar.2021.768023
Recent Therapeutic Progress and Future Perspectives for the Treatment of Hearing Loss.
Lye J, Delaney DS, Leith FK, Sardesai VS, et al · · 2023 · cited 16× · PMID 38137568 · DOI 10.3390/biomedicines11123347
Pharmaceutical Agents for Targeting Autophagy and Their Applications in Clinics.
Kench U, Sologova S, Smolyarchuk E, Prassolov V, et al · · 2024 · cited 6× · PMID 39458996 · DOI 10.3390/ph17101355
Chronic Stress Alters Hippocampal Renin-Angiotensin-Aldosterone System Component Expression in an Aged Rat Model of Wolfram Syndrome.
Punapart M, Reimets R, Seppa K, Kirillov S, et al · · 2023 · cited 2× · PMID 37107585 · DOI 10.3390/genes14040827

Verify or expand the search:

Other recruiting trials for Wolfram Syndrome

Currently open trials in the same condition.

NCT05676034 — AMX0035 in Adult Patients With Wolfram Syndrome · Phase 2 · active not recruiting
NCT03988764 — Monogenic Diabetes Misdiagnosed as Type 1 · recruiting
NCT03717909 — Efficacy and Safety Trial of Sodium Valproate, in Paediatric and Adult Patients With Wolfram Syndrome · Phase 2 · active not recruiting

Other Centre d'Etude des Cellules Souches trials

Trials by the same sponsor.

NCT03963154 — Interventional Study of Implantation of hESC-derived RPE in Patients With RP Due to Monogenic Mutation · Phase 1, PHASE2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04940572 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre d'Etude des Cellules Souches
Last refreshed: 28 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04940572.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing