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.
The treatment duration is 2 weeks per period. Each treatment period is followed by a one-week washout period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
77
THN102 Dosages A: placebo
THN102 Dosage B : 200mg/2mg
THN102 Dosage C: 200mg/18mg
Safety Adverse Events
Number of participants with spontaneously reported treatment-related adverse events
Time frame: 2 weeks
Epworth Sleeping Scale (ESS)
Range of the scale : 0 to 24. A low score indicates a good outcome. Results shown are corresponding to a change from baseline of the ESS score.
Time frame: 2 weeks
Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline
PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.
Time frame: 2 weeks
Montreal Cognitive Assessment Battery (MoCA)
MoCA score reflects the cognitive capacities of a person. Range of the total score of 10 test items: 0 to 30 points. A high score indicates good cognitive functioning. A score of 26 and above is considered normal. The results below are shown as change from baseline of the MoCA score.
Time frame: 2 weeks
Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline
ESS score responder rate, defined as the proportion of subjects with at least 25% ESS improvement from baseline, at the end of each treatment period
Time frame: 2 weeks
Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline
Number of patients in remission (=without residual sleepiness), i.e. ESS \< 11 at the end of each treatment period
Time frame: 2 weeks
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