Trials / Completed
CompletedNCT03624920
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Theranexus · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.
Detailed description
The treatment duration is 2 weeks per period. Each treatment period is followed by a one-week washout period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | THN102 Dosage A | THN102 Dosages A: placebo |
| DRUG | THN102 Dosage B | THN102 Dosage B : 200mg/2mg |
| DRUG | THN102 Dosage C | THN102 Dosage C: 200mg/18mg |
Timeline
- Start date
- 2018-07-12
- Primary completion
- 2019-12-20
- Completion
- 2020-02-24
- First posted
- 2018-08-10
- Last updated
- 2020-12-01
- Results posted
- 2020-12-01
Locations
34 sites across 5 countries: United States, Czechia, France, Germany, Hungary
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03624920. Inclusion in this directory is not an endorsement.