Opicapone in clinical practice (OPTIPARK)

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2016-002391-27-GB
• Date of registration: 04/08/2016
• Prospective Registration: Yes
• Primary sponsor: BIAL - Portela & Ca, S.A.
• Public title: Opicapone in clinical practice (OPTIPARK)
• Scientific title: This action will amend the information submitted in this data field for all relevant applications. Please refer to the guidance under the Amendment tab and consider whether further notification to review bodies is required. - Opicapone in clinical practice (OPTIPARK)_V1
• Date of first enrolment: 07/10/2016
• Target sample size: 550
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002391-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Germany, United Kingdom

Contacts

• Name: Global Medical Affairs Manager
• Affiliation: BIAL - Portela & Ca, S.A.

• Name: Global Medical Affairs Manager
• Affiliation: BIAL - Portela & Ca, S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Able to comprehend and willing to sign an informed consent form.
2. Male and female subjects aged 30 years or older.
3. Diagnosed with idiopathic PD according to the UK Parkinson’s Disease Society
Brain Bank Clinical Diagnostic Criteria.
4. Disease severity Stages I-IV (modified Hoehn &Yahr staging) at ON.
5. Treated with three to seven daily doses of L-dopa/DDCI or L-dopa/DDCI/entacapone,
which can include a slow-release formulation.
6. Signs of “wearing-off” phenomenon according to the 9-Symptom Wearing-off
Questionnaire (WOQ-9), despite optimal anti-PD therapy (based on the
investigator’s judgement). The wearing-off phenomenon has to be confirmed
clinically by the investigator.
7. For females: Postmenopausal for at least two years or surgically sterile for at
least six months before screening.
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion criteria:
1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic]
parkinsonism, Parkinson-plus syndrome).
2. Severe OFF periods. Patients with rare and/or short unpredictable OFF periods are
eligible.
3. Previous or current use of tolcapone and/or OPC.
4. Treatment with monoamine oxidase inhibitors (MAO-A and MAO-B; except selegiline
up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption
formulation or rasagiline up to 1 mg/day or safinamide up to 100 mg/day) within
the month before screening.
5. Concomitant treatment with entacapone.
6. Use of any other investigational medicinal product (IMP), currently or within the
three months (or within five half-lives of the IMP, whichever is longer) before
screening.
7. Any medical condition that might place the subject at increased risk or interfere
with assessments.
8. Past (within the past year) or present history of suicidal ideation or suicide
attempts.
9. Current or previous (within the past year) alcohol or substance abuse excluding
caffeine or nicotine.
10. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
11. Known hypersensitivity to the ingredients of IMP (including lactose intolerance,
galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption).
12. History of neuroleptic malignant syndrome (NMS) or non-traumatic rhabdomyolysis.
13. Severe hepatic impairment (Child-Pugh Class C).
14. For females: Breastfeeding.
15. Employees of the investigator, trial centre, sponsor, clinical research
organisation and trial consultants, when employees are directly involved in the trial or other studies under the direction of this investigator or trial centre, and their family members.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Parkinson's disease (PD) patients with wearing-off motor fluctuations
MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Ongentys
Product Name: Ongentys
Pharmaceutical Form: Capsule, hard

Primary Outcome(s)

Main Objective: To evaluate the change in the participant's Parkinson's disease according to the Investigator’s Global Assessment of Change after six months of treatment with opicapone

Secondary Objective: • To show that opicapone is safe when given according to local practise.
• To show that opicapone is effective at treating Parkinson's disease (PD) when given
according to local practise.
• To show that opicapone is cost effective in the treatment of PD

Primary end point(s): The primary endpoint for this trial is the Investigator's Global Assessment of Change at Visit 4.

Timepoint(s) of evaluation of this end point: Visit 4

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Visit 3, Visit 4 and Visit 5

Secondary end point(s): Secondary efficacy endpoints:
- Change in L-dopa total daily dose from baseline (Visit 1) to each on-site visit.
- Number and percentage of subjects with change in number of daily Ldopa doses from
baseline (Visit 1) at each on-site visit.
- Number and percentage of subjects with change in L-dopa single dose (SD) from
baseline (Visit 1) at each on-site visit.
- Number and percentage of subjects with stable L-dopa regimen between Visit 3 and
Visit 4.
- Number and percentage of subjects for whom OPC will be prescribed further after
trial completion.
- Number and percentage of subjects who stopped treatment with OPC before trial
completion or at Visit 4 due to:
- AEs
- Lack of efficacy
- Other reasons
- Investigator's Global Assessment of Change at Visit 3.
- Subject's Global Assessment of Change at Visit 3 and Visit 4.
- Absolute values and, if applicable, change from baseline at each on-site
visit in WOQ-9.
- Absolute values and, if applicable, change from baseline to Visit 4:
- UPDRS I mentation, behaviour, and mood at ON stage
- UPDRS II (activities of daily living, ADL) at OFF stage
- UPDRS II (ADL) plus III (motor function) during the ON stage
- UPDRS IV at ON stage
- PDQ-8
- NMSS


Secondary safety endpoints:
- Incidence of AEs including SAEs.
- General safety information (vital signs, physical and neurological examinations).
- BIA 9-1103, BIA 9-4588 and potential other relevant OPC metabolites’ plasma concentration at Visit 5, after 6-month treatment with OPC.

Secondary ID(s)

NCT02847442

BIA-OPC-401

Source(s) of Monetary Support

BIAL -Portela & Ca, S.A.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 17/10/2019
• Date Completed: 10/07/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002391-27/results