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Authors
Oertel, Wolfgang H.
Henrich, Martin T.
Sittig, Elisabeth
Meyer, Philipp T.
Strupp, Michael
Janzen, Annette
Geibl, Fanni F.
Ruppert, Elisabeth
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Funding
Funding for this research was provided by:
Philipps-Universität Marburg
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Article History
Received: 9 July 2025
Accepted: 16 September 2025
First Online: 2 October 2025
Declarations
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: This case report was conducted in accordance with the principles of the Declaration of Helsinki. No formal ethical approval was required, as this report describes the treatment of three individual patients under compassionate use (“Heilversuch”) with Acetyl-DL-Leucine (Tanganil™), outside of a clinical trial (clinical trial number: not applicable). Written informed consent was obtained from all three patients for the compassionate off-label use of ADLL, for clinical follow-up to evaluate its safety and efficacy, and for publication of their case descriptions.
: Written informed consent for publication was obtained from all three patients.
: This case observational study in three patients has been conducted with the drug TanganilTM. This drug contains the racemate Acetyl-DL-Leucine, i.e. to equal parts the bio-inactive substance Acetyl-D-Leucine and the bioactive enantiomer Acetyl-L-Leucine. This drug is produced by the company Pierre Fabre, Medicaments, France and approved for the indication vertigo in France. The company Pierre Fabre was not aware of our observational study as none of the authors had any contact during and after the conduct of the study with the company.Wolfgang Oertel (WO) and Michael Strupp (MS) are members of the scientific advisory board of the company IntraBio. WO holds stock options of the company IntraBio, whereas MS is an investor and shareholder of the company Intrabio. In addition, we declare that neither the company Pierre Fabre nor the company IntraBio have supported the conduct of the case report submitted with this article by any means.Wolfgang H. Oertel also acts as a consultant for the company MODAG. He holds stock options with MODAG unrelated to this work. Elisabeth Sittig has no conflict of interest to declare. Philipp T. Meyer has no conflict of interest to declare. Fanni F. Geibl has no conflict of interest to declare. Martin T. Henrich has no conflict of interest to declare. Elisabeth Ruppert has no conflict of interest to declare. Michael Strupp is Joint Chief Editor of the Journal of Neurology, Editor in Chief of Frontiers Neuro-otology and Section Editor of F1000. He acts as a consultant for Abbott, AurisMedical, Bulbitec, Heel, Sensorion and Vertify. The institution of M.S., not M.S. personally received/s support for clinical studies from Decibel, U.S.A., Cure within Reach, U.S.A. and Heel, Germany.
