OpicApone Sleep dISorder

NCT04986995 | Completed Phase 4

• 2 other identifiers: BIA-91067-4052020-001176-15
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Total score of Parkinson's Disease Sleep Scale - version 2 (PDSS-2)

  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)

  Up to 6 weeks

Study Arms (1)

Opicapone

EXPERIMENTAL

50 mg hard capsules

Drug: Opicapone

Interventions

Opicapone DRUG

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

Also known as: BIA 9-1067

Opicapone

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and willing to sign an informed consent form and to comply with all aspects of the study.
• Male or female patients aged 30 years or older.
• 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).
• 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).
• Disease severity Stages I-III (modified Hoehn \& Yahr staging) at ON.
• Experiencing PD associated sleep disorders for at least 4 weeks prior to V1.
• Total PDSS-2 score ≥ 18.
• 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.
• 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.
• 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
• 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.
• 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.
• 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.
• Total PDSS-2 score ≥ 18.

You may not qualify if:

• Non-idiopathic PD (atypical parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, Parkinson-plus syndrome).
• Severe and/or unpredictable OFF periods, according to investigator judgement.
• Major/prominent non-PD-related sleep disorders (e.g. sleep apnoea or narcolepsy).
• 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.
• Treatment with apomorphine within the last 4 weeks before V1 or likely to be needed at any time until V4.
• Previous or current use of opicapone.
• 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).
• 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.
• Past (within the past year) or present history of suicidal ideation or suicide attempts.
• Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine.
• Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
• Known hypersensitivity to the excipients of IP (including lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption).
• History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis.
• History of severe hepatic impairment (Child-Pugh Class C).
• Previous history of psychosis or psychiatric disorders, including severe major depression.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Hospital da Senhora da Oliveira - Guimarães, E.P.E, Serviço de Neurologia

Guimarães, 4835-044, Portugal

Location

Related Publications (1)

• 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.

  PMID: 21312275 BACKGROUND

Related Links

• Parkinson's disease sleep scale--validation of the revised version PDSS-2

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: June 9, 2021
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

PT (1)