OpicApone Sleep dISorder (OASIS)

• ClinicalTrials.gov Identifier: NCT04986995
• Recruitment Status: Active, not recruiting
• First Posted: August 3, 2021
• Last Update Posted: April 14, 2023
• Sponsor: Bial - Portela C S.A.
• Information provided by (Responsible Party): Bial - Portela C S.A.

Tracking Information

• First Submitted Date: July 27, 2021
• First Posted Date: August 3, 2021
• Last Update Posted Date: April 14, 2023
• Actual Study Start Date: June 9, 2021
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 2, 2021)

Total score of Parkinson's Disease Sleep Scale - version 2 (PDSS-2) [ Time Frame: Up to 6 weeks ]

Parkinson's Disease Sleep Scale version 2 (PDSS-2) is a patient-completed clinical rating scale that assesses the frequency of sleep disturbances over the past week. Each question is scored between 0 ("never") and 4 ("very often"), and a total score is calculated by summing a patient's responses to each of the 15 questions (minimum 0 to maximum 60)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: OpicApone Sleep dISorder
• Official Title: Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders
• Brief Summary: The aim of this study is to To investigate in an exploratory manner the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's disease (PD) patients with end-of-dose motor fluctuations and associated sleep disorders
• Detailed Description: This is an open-label, single-arm, multi-centre, interventional clinical study in PD patients with end-of-dose motor fluctuations and associated sleep disorders. The study consists of a 1-week screening period, a 6-week treatment period and 2 weeks of follow-up period. Expected duration of treatment for the individual patient is up to 6 weeks.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Parkinson Disease

Intervention

Drug: Opicapone

Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

Other Name: BIA 9-1067

Study Arms

Experimental: Opicapone

50 mg hard capsules

Intervention: Drug: Opicapone

• Publications *: Trenkwalder C, Kohnen R, Hogl B, Metta V, Sixel-Doring F, Frauscher B, Hulsmann J, Martinez-Martin P, Chaudhuri KR. Parkinson's disease sleep scale--validation of the revised version PDSS-2. Mov Disord. 2011 Mar;26(4):644-52. doi: 10.1002/mds.23476. Epub 2011 Feb 10.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 13, 2023): 22
• Original Estimated Enrollment (submitted: August 2, 2021): 30
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Exclusion Criteria:

1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
2. Severe and/or unpredictable OFF periods, according to investigator judgement.
3. Major/prominent non-PD-related sleep disorders (e.g. sleep apnoea or narcolepsy).
4. Treatment with prohibited medication: entacapone, tolcapone, monoamine oxidase (MAO) inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation, rasagiline up to 1 mg/day or safinamide up to 100 mg/day), or antiemetics with antidopaminergic action (except domperidone) within the last 4 weeks before V1 or likely to be needed at any time until V4.
5. Treatment with apomorphine within the last 4 weeks before V1 or likely to be needed at any time until V4.
6. Previous or current use of opicapone.
7. Previous or planned (until the end of this study) L-dopa/carbidopa intestinal gel infusion, deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
8. Use of any other investigational product (IP), currently or within the 3 months (or within 5 half-lives of the IP, whichever is longer) before V1.
9. Past (within the past year) or present history of suicidal ideation or suicide attempts.
10. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine.
11. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
12. Known hypersensitivity to the excipients of IP (including lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption).
13. History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis.
14. History of severe hepatic impairment (Child-Pugh Class C).
15. Previous history of psychosis or psychiatric disorders, including severe major depression.
16. Any medical condition that might place the patient at increased risk or interfere with assessments.
17. For females: Pregnant or breastfeeding.
18. Employees of the investigator, study centre, sponsor, clinical research organisation and study consultants, when employees are directly involved in this study or other studies under the direction of this investigator or study centre, and their family members.
19. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Portugal

Administrative Information

• NCT Number: NCT04986995
• Other Study ID Numbers: BIA-91067-405; 2020-001176-15 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Bial - Portela C S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: Bial - Portela C S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bial - Portela C S.A.
• Verification Date: April 2023