Phase 2
N=77
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03624920 ↗Enrolled (actual)
77
Serious AEs
0.5%
Results posted
Dec 2020
Primary outcome: Primary: Safety Adverse Events — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- THN102 Dosage A (Drug); THN102 Dosage B (Drug); THN102 Dosage C (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Theranexus
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Adverse Events |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Epworth Sleeping Scale (ESS) |
-2.4422; -3.8417; -3.1850 | — |
| SECONDARY Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline |
-21.2201; -24.1089; -19.6450 | — |
| SECONDARY Montreal Cognitive Assessment Battery (MoCA) |
0.2240; 0.03267; 0.4251 | — |
| SECONDARY Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline |
19; 28; 25 | — |
| SECONDARY Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline |
11; 19; 18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects with a diagnosis of idiopathic Parkinson's disease as defined by the Movement Disorders Society (MDS).
- Subjects with Hoehn and Yahr scale score ≤ 4.
- Body mass index > 18 kg/m2 and < 35 kg/m2.
- Subjects should have a complaint of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g. falling asleep while reading or watching television, while eating or talking with other people).
- Epworth Sleepiness Scale (ESS) score ≥ 14.
Exclusion Criteria
- Subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness, such as shift work sleep disorder.
- Psychiatric and neurological disorders (other than Parkinson's disease),
- Cardiovascular disorders such as - but not limited to
- Uncontrolled moderate to severe hypertension
- History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study
- Recent myocardial infarction
- Stable or unstable angina pectoris
- Cardiac insufficiency or history of heart failure
- Previous history of cardiac valvular surgery
- Subjects with current impulse control disorder.
- Subjects showing dementia or with MoCA < 23.
- Subjects with current suicidal risk
- Current or recent (within one year) history of substance abuse or dependence disorder
- Other active clinically significant illness
- Subjects with hepatic or renal impairment
Data sourced from ClinicalTrials.gov (NCT03624920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.