Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02764125
• Date of registration: 13/01/2016
• Prospective Registration: Yes
• Primary sponsor: Orion Corporation, Orion Pharma
• Public title: Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC) COMPOC
• Scientific title: Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off
• Date of first enrolment: April 8, 2016
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02764125
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Finland, Germany, Hungary, Latvia

Contacts

• Name: Aila Holopainen, MSc
• Affiliation: Orion Corporation, Orion Pharma, Development

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent (IC) obtained.

- Male or female patients with idiopathic PD according to the UK brain bank criteria
with end-of-dose wearing-off (motor fluctuations).

- Hoehn and Yahr stage 2-4 performed during the ON-state.

- At least 2 hours of OFF-time on each day (measured by the ON/OFF diary) on 3
consecutive days at the end of the screening period just before the baseline visit
(visit 1).

- Treatment with 4-8 daily doses of levodopa/AADC inhibitor, either combined with
entacapone (levodopa/AADC inhibitor combined with Comtess/Comtan or as Stalevo) or
without entacapone, with a total daily levodopa dose from > 400 mg to = 1200 mg with
entacapone, or from > 400 mg to = 1400 mg without entacapone. One evening dose of
controlled release formulation, 1 morning dose of soluble levodopa/AADC inhibitor, or
both, as needed are allowed.

- Unchanged levodopa/AADC inhibitor with or without entacapone, and other
antiparkinsonian medication (dopamine agonists, monoamine oxidase [MAO] B inhibitor,
amantadine and/or anticholinergics with doses recommended by the manufacturer), if
any, for at least 4 weeks before the screening visit.

- Age of 30 years or above.

Exclusion Criteria:

- Secondary or atypical Parkinsonism.

- Current use of tolcapone or opicapone (within 4 weeks before the screening visit).

- Previous tolerability problems with entacapone, tolcapone or opicapone.

- Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO
inhibitors (within 4 weeks before the screening visit).

- Concomitant treatment with drugs having antidopaminergic action including
alpha-methyldopa, reserpine and antipsychotic drugs (also D2 receptor blocking
antiemetics except domperidone). As an exception to prohibit use of antipsychotic
drugs, 1 evening dose of an atypical antipsychotic is allowed.

- Use of concomitant medicine which is predominantly metabolised by CYP3A4 and which has
a narrow therapeutic window such as ergot alkaloids, carbamazepine, cyclosporin,
macrolides (sirolimus and tacrolimus), quinidine or fentanyl.

- Current use of warfarin (within 4 weeks before the screening visit).

- Inability to refrain from use of any iron preparations during the study.

- Disabling dyskinesias.

- Problematic hallucinations within 3 months before the screening visit.

- Symptomatic orthostatic hypotension.

- Current dementia (Mini Mental State Examination [MMSE] score < 26).

- Problematic impulse control disorders (ICDs), such as pathological gambling,
hypersexuality or compulsive shopping within 6 months before the screening visit.

- History of neuroleptic malignant syndrome (NMS), non-traumatic rhabdomyolysis, or
both.

- Any neurosurgical intervention for the treatment of PD, including deep brain
stimulation (DBS).

- Narrow-angle glaucoma or pheochromocytoma.

- Any active malignant cancer.

- Clinically significant cardiovascular (e.g. ischaemic heart disease, ventricular or
supraventricular arrhythmias), pulmonary, GI (e.g. inflammatory bowel disease),
hepatic, renal, neurological or psychiatric disorder or any other major concurrent
illness that in the opinion of the investigator would interfere with the
interpretation of the study results or constitute a health risk for the subject if
he/she takes part into the study.

- Alanine aminotransferase or aspartate aminotransferase > 1.25 x upper limit of normal
(ULN) at screening.

- Any other abnormal value of laboratory, vital signs or ECG (such as QTcF prolongation
= 450 ms) that may in the opinion of the investigator interfere with the
interpretation of the study results or cause health risk for the subject if he/she
takes part into the study.

- Female patients of childbearing potential (i.e. menstruating or less than 2 years
postmenopausal).

- Patients with pre-planned surgery requiring hospitalisation during the study.

- Known hypersensitivity to active substances or to any of the excipients of the study
treatments.

- Blood donation or loss of significant amount of blood within 60 days before screening
visit.

- Participation in a drug study within 60 days before the first treatment period.

- Any other condition that in the opinion of the investigator would interfere with the
interpretation of the study results or constitute a health risk for the subject if
he/she takes part into the study.

- Failure to demonstrate acceptable/appropriate use of the ON/OFF diary despite adequate
training during the screening visit.



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: levodopa MR

Drug: Stalevo

Primary Outcome(s)

Duration of daily OFF-time (measured by Hauser ON/OFF-diary) [Time Frame: 3 consecutive days in the end of both periods compared to 3 consecutive days prior the baseline visit.]

Secondary Outcome(s)

Switching patients from their regular levodopa treatment to planned new treatment. [Time Frame: two 4 weeks study periods]

To show adequate Parkinson's Disease symptom control with the new treatment [Time Frame: two 4 weeks study periods]

Determination of sample size [Time Frame: two 4 weeks study periods]

Secondary ID(s)

3112004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors