OpicApone Sleep dISorder

Inclusion Criteria

• •1. Able to comprehend and willing to sign an informed consent form and to comply with all aspects of the study.
• •2. Male or female patients aged 30 years or older.
• •3. Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (2006) or according to MDS Clinical Diagnostic Criteria (2015).
• •4. Signs of "wearing-off" phenomenon (end-of-dose motor fluctuations) with average total daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on investigator's assessment).
• •5. Disease severity Stages I-III (modified Hoehn \& Yahr staging) at ON.
• •6. Experiencing PD associated sleep disorders for at least 4 weeks prior to V1.
• •7. Total PDSS-2 score ≥ 18.
• •8. Treated with 3 to 8 intakes per day of L-dopa/DDCI (which may include a slow-release formulation), on a stable regimen for at least 4 weeks before V1.
• •9. In case of any other anti-PD treatment, it should be on a stable regimen for at least 4 weeks before V1, and not likely to need any adjustment until V4.
• •10. No change in the chronic treatment regimen within the last 4 weeks before V1 of the following medication: sedatives, hypnotics, anti-depressants, anxiolytics or other medications prescribed for the treatment of sleep disorders
• •11. For females: Postmenopausal for at least 2 years before V1, surgically sterile for at least 6 months before V1, or practicing an effective method of contraception until V4. Female patients who request to continue with oral contraceptives must be willing to use non-hormonal methods of contraception in addition during the course of this study.
• •For males: Male patients who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception during the treatment period until V4.
• •12. Have filled-in self-rating diary in accordance with the diary instructions and with ≤ 3 errors per day when awake, in the 3 days preceding V2a/V2b.
• •13. With at least 1.5 OFF hours per day, excluding the early morning pre-first dose OFF period (i.e. the time between wake-up and response to the first L dopa/DDCI dosage), as recorded in at least 2 of the 3 days in the self-rating diary for the 3 days preceding V2a/V2b.
• •14. Total PDSS-2 score ≥ 18.
• •15. Adequate compliance to relevant (PD and sleep disorders) concomitant medication during the screening period (based on the investigator's judgment).