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Table 2 Inclusion and exclusion criteria

From: Opicapone versus placebo in the treatment of Parkinson’s disease patients with end-of-dose motor fluctuation-associated pain: rationale and design of the randomised, double-blind OCEAN (OpiCapone Effect on motor fluctuations and pAiN) trial

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
  1. aIn Germany only, Age > 50 years
  2. bModified Hoehn and Yahr staging
  3. cAtypical parkinsonism, secondary (acquired or symptomatic) parkinsonism, Parkinson-plus syndrome. “Idiopathic PD” was defined according to UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria (2006) or Movement Disorder Society Clinical Diagnostic Criteria for Parkinson’s disease (2015)
  4. dIncludes medication (e.g. paracetamol, opioids, nonsteroidal anti-inflammatory drugs, antidepressants, anticonvulsants, corticosteroids) and non-medication therapies (e.g. transcutaneous electrical nerve stimulation, bioelectrical therapy)
  5. eMay include a slow-release formulation
  6. fEntacapone, tolcapone, monoamine oxidase inhibitors (except selegiline up to 10 mg/day [oral] or 1.25 mg/day [buccal], rasagiline up to 1 mg/day, safinamide up to 100 mg/day) or antiemetics with anti-dopaminergic action (except domperidone)
  7. gFemale patients requesting to continue with oral contraceptives must be willing to additionally use non-hormonal methods of contraception during the course of the study
  8. hIncluding lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  9. iChild-Pugh Class C
  10. DDCi dopa decarboxylase inhibitor, KPPS King’s Parkinson’s Disease Pain Scale, OPC opicapone, PD Parkinson’s disease, V visit