Table 2 Inclusion and exclusion criteria
Category of characteristic | Inclusion criteria | Exclusion criteria |
|---|---|---|
Demographics | • Male or female • Age ≥ 30 yearsa | |
Disease-related characteristics | • Disease severity Stages I–III at ONb • Signs of ‘wearing-off’ phenomena (end-of-dose fluctuations) with average total daily OFF time while awake ≥1.5 h (excluding early morning pre-first dose OFF period), despite optimal anti-PD therapy, according to the investigator’s judgment at V1 • At least 1.5 OFF h/day (excluding early morning pre-first dose OFF period), as recorded in the self-rated diary, during at least 2 of the 3 days prior to V2 | • Non-idiopathic PDc • Severe and/or unpredictable OFF periods (investigator’s judgment) |
Pain-related characteristics | • Experiencing PD-associated pain for ≥4 weeks prior to V1 • Domain 3 of KPPS ≥12 at V1 and V2 • No changes in chronic treatment regimen for pain within 4 weeks prior to V1d | • Major/prominent non-PD-related pain (e.g. due to malignant disease) |
Anti-PD medication | • Treated with 3–8 intakes/day of levodopa/DDCie and on a stable regimen for ≥4 weeks prior to V1 • Any other anti-PD medication regimen, if applicable, should remain stable for ≥4 weeks prior to V1 and should not be likely to require any adjustment until V6 | • Treatment with prohibited medicationf within the 4 weeks prior to V1 • Treatment with apomorphine with 4 weeks prior to V1 or likely to be needed at any time until V6 • Previous or planned (during the entire study duration) levodopa/carbidopa intestinal gel infusion, deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy) • Previous or current use of OPC • Use of any other investigational product, currently or within 3 months (or five half-lives of the investigational product, whichever is longer) prior to V1 |
Compliance | • Adequate compliance with relevant PD and pain-related medication during the screening period (investigator’s judgment) at V2 • Filled in the self-rating diary in accordance with the diary instructions and with ≤3 missing entries/day in the 3 days prior to V2 | |
Safety | • Acceptable results of screening laboratory tests (i.e. not clinically relevant for the well-being of the patient or for the purpose of the study according to investigator’s judgment) at V2 • For female patients: postmenopausal for ≥2 years before V1, surgically sterile for ≥6 months before V1, or practicing effective contraception until V6g • For male patients: use of condoms plus an approved method of highly effective contraception during the treatment period up to V6, if sexually active with a partner of childbearing potential | • Current or past (within previous year) history of suicidal ideation, suicide attempts or alcohol or substance abuse, excluding caffeine or nicotine • Pheochromocytoma, paraganglioma or other catecholamine-secreting neoplasms • Known hypersensitivity to the excipients of the investigation producth or rescue medication • History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis • History of severe hepatic impairmenti • Previous history of psychosis or psychiatric disorders, including severe major depression • Any medical condition that might place the patient at increased risk or interfere with assessments • For female patients: pregnant or breastfeeding |