Prospective, Open-Label, Single-Center Pilot Study on the Efficacy of Daily Tadalafil in Early-Stage Parkinson’s Disease
interventional
N/A
1 country
1
To assess whether daily tadalafil improves motor symptoms in Parkinson-drug naïve patients with early-stage Parkinson’s disease over a two-week follow-up period
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 23, 2025
Actual (reported)Change in motor symptoms using the MDS-UPDRS part III from baseline to two weeks after daily tadalafil administration.
All adverse events will be recorded during follow-up. The following specific side effects will be assessed (yes/no): 1) Headache, 2) Dyspepsia, 3) Back pain, 4) Muscle pain, 5) Flushing, 6) Nasal congestion, 7) Unwanted erections, and 8) Changes in libido. Blood pressure (mmHg) and heart rate (bpm) will be measured at baseline and after two weeks.
Participant’s evaluation of the burden of the treatment after two weeks follow-up will be measured with a five-point Likert-type item.
Participant’s satisfaction on the outcome of treatment after two weeks follow-up will be measured with a five-point Likert scale.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Amsterdam UMC Research B.V.
Amsterdam, 1105 AZ, Netherlands
Prof. dr. R.M.A. de Bie
First Submitted
September 23, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms
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