Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease.

Phase 1

• Conditions: Parkinson's disease patients with wearing-off motor fluctuations andassociated pain.; MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-001175-32-GB
• Lead Sponsor: Bial - Portela & Ca, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-07
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Inclusion criteria at Visit 1 (Screening):
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. Experiencing PD associated pain for at least 4 weeks prior to screening.
4. 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).
5. Disease severity Stages I-III (modified Hoehn & Yahr staging) at ON.
6. Treated with 3 to 7 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.
7. 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 V6.
8. No changes in chronic treatment regimen for pain within the last 4 weeks
before V1. This includes medication (including but not limited to paracetamol,
opioids, nonsteroidal anti-inflammatory drugs [NSAIDS], antidepressants,
anticonvulsants and corticosteroids) and non-medication therapies (including
but not limited to transcutaneous electrical nerve stimulation and
bioelectrical therapy).
9. 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).
10. Domain 3 of KPPS = 12.
11. For females: Postmenopausal for at least 2 years before V1, surgically
sterile for at least 6 months before V1, or practicing effective
contraception until V6. 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 V6.

Inclusion Criteria at V2b (Baseline):
12. Have filled-in self-rating diary in accordance with the diary instructions
and with = 3 missing entries per day, 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. Results of the screening laboratory tests are considered acceptable by the
investigator (i.e. not clinically relevant for the well-being of the patient
or for the purpose of the study).
15. Domain 3 of KPPS = 12.
16. Adequate compliance to relevant (PD and pain related) concomitant medication
during the screening period (based on the investigator’s judgment).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 176
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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 pain (e.g. due to malignant disease).
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.
5. Previous or planned (during the entire study duration) L-dopa/carbidopa
intestinal gel infusion, deep brain stimulation or stereotactic surgery (e.g.
pallidotomy, thalamotomy).
6. Treatment with apomorphine within the last 4 weeks before V1 or likely to be
needed at any time until V6.
7. Previous or current use of opicapone.
8. Use of any other 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) or of rescue medication.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To see if Opicapone 50mg has an effect on Parkinson's disease patients who suffer from PD related pain compared to placebo.;Secondary Objective: 1. To see the effect of opicapone 50 mg in reducing further PD symptoms.<br>2. To see if opicapone 50 mg taken once a day is safe and well tolerated.;Primary end point(s): Change from baseline in Domain 3 (fluctuation-related pain) of King’s Parkinson’s Disease Pain Scale (KPPS).;Timepoint(s) of evaluation of this end point: At the end of the trial.