A Phase 1 interventional study of Betahistine dihydrochloride and Selegiline-hydrochloride in Ménière's Disease, sponsored by Ludwig-Maximilians - University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Ludwig-Maximilians - University of Munich · Phase 1, Interventional, and Treatment
The goal of this pharmakokinetic trial is to demonstrate that Betahistine serum concentration is higher after combination treatment with Betahistine and Selegiline compared to Betahistine alone.
The main questions it aims to answer are:
Is the plasma concentration of betahistine higher due to combination treatment with selegiline compared to betahistine monotherapy? How is the safety of the combination treatment with betahistine and selegiline, the pharmacokinetics of betahistine in different dosages in blood, and the inter-individual differences in the metabolism?
Subjects satisfying all selection criteria will receive three different dosages of Betahistine alone orally in ascending order (24 mg, 48 mg, 96 mg) in the first period. In the second period, subjects received Betahistine treatment as described for first period but after pre- and continuous treatment with 5 mg/ml Selegiline orally. Plasma concentration (namely the AUC0-240min) of betahistine will be measured before and 10, 30, 60, 90, 120, 180, 240 minutes after treatment with blood examinations. Safety parameters include assessment of adverse events, ECG, vital signs, laboratory measurements including kidney and liver function, full blood count and pregnancy and drug screening test.
This study was an investigator-initiated (IIT) prospective mono-center open-labeled trial to demonstrate that Betahistine serum concentration is higher after combination treatment with Betahistine and Selegiline compared to Betahistine alone in healthy subjects.
Subjects were screened for their eligibility to participate in the study. Each subject gave written informed consent before any study-related procedures were performed.
Subjects satisfying all selection criteria were included in the open-labeled trial receiving 3 different dosages of Betahistine alone in ascending order (24 mg, 48 mg, 96 mg) in the first period. In the second period, subjects received Betahistine treatment as described for first period but after pre- and continuous treatment with 5 mg/ml Selegiline. Betahistine serum concentrations were measured over a period of 240 min at 8 time points (area under the curve, AUC0-240 min). Safety parameters included assessment of adverse events, ECG, vital signs, laboratory measurements including kidney and liver function, full blood count and pregnancy and drug screening test). Safety monitoring was conducted during every visit and assessment of vital parameter and adverse events were conducted 10, 30, 60, 90, 120, 180, and 240min after betahistine intake. The clinical trial was conducted in a hospital of maximum care with the possibility to consult a specialist for possible symptoms of an intoxication especially an anesthesiologist, cardiologist and neurologist 24 hours/7 days a week.
73 studies on the registry are indexed under Meniere Disease; 14 are open to participants now.
This study's enrollment of 15 is below the median of 49 across 62 interventional studies indexed under Meniere Disease.
Browse Meniere Disease studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.
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Diagnosis and main criteria for inclusion:
Subjects presenting with any of the following exclusion criteria were not included in the trial:
Subjects received single dosages of Betahistine (24 mg, 48 mg, 96 mg) orally for pharmacokinetic serum draw with at least two days between the different dosages.
Drug: Betahistine dihydrochloride
Subjects were pre-treated with Selegiline (5 mg/day) orally for one week and treated continuously with Selegiline (5 mg/day) in combination with the single dosages of Betahistine (24 mg, 48 mg, 96 mg) orally with at least two days between the different dosages.
Drug: Betahistine dihydrochloride · Drug: Selegiline-hydrochloride
Each subject received single dosages of Betahistine (24 mg, 48 mg, 96 mg) for pharmacokinetic serum draw with at least two days between the different dosages.
Also known as: Vasomotal
In the second period, each subject was pre-treated with Selegiline (5 mg/day) for one week and treated continuously with Selegiline (5 mg/day) in combination with the single dosages of Betahistine (24 mg, 48 mg, 96 mg) with at least two days between the different dosages.
Also known as: Selegiline-neuraxpharm
Mean AUC of Betahistine
Mean AUC of Betahistine in serum after treatment of Betahistine alone or with Selegiline
Time frame: 240 minutes
Mean Half Life of Betahistine
Half Life of Betahistine following the administration of different Betahistine doses with and without Selegiline
Time frame: 240 minutes
Occurrence of adverse effects
Occurrence of adverse effects following the administration of different Betahistine doses with and without Selegiline
Time frame: up to 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Ludwig-Maximilians - University of Munich