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

NCT02764125 | Completed Phase 2

• 1 other identifier: 3112004
• Study Type: interventional
• Target: 84
• Locations: 4 countries
• Sites: 4

Brief Summary

This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with end-of-dose wearing-off (motor fluctuations).

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Wearing-off

Outcome Measures

Primary Outcomes (1)

• Duration of daily OFF-time (measured by Hauser ON/OFF-diary)

  OFF-time (time when the patient does not experience a positive response to medication between the study drug intake) measured from the Hauser ON/OFF-diary that patient has filled in (24 hour clock) for 3 days prior to baseline visit and at the end of both treatment periods.

  3 consecutive days in the end of both periods compared to 3 consecutive days prior the baseline visit.

Secondary Outcomes (3)

• Switching patients from their regular levodopa treatment to planned new treatment.

  two 4 weeks study periods

• Determination of sample size

  two 4 weeks study periods

• To show adequate Parkinson's Disease symptom control with the new treatment

  two 4 weeks study periods

Study Arms (2)

Stalevo

ACTIVE COMPARATOR

levodopa/carbidopa/entacapone

Drug: Stalevo

levodopa MR

EXPERIMENTAL

Levodopa MR/carbidopa/ODM-104

Drug: levodopa MR

Interventions

Stalevo DRUG

levodopa/carbidopa/entacapone

Also known as: levodopa/carbidopa/entacapone

Stalevo

levodopa MR DRUG

levodopa MR/carbidopa/ODM-104

Also known as: levodopa MR/carbidopa/ODM-104

levodopa MR

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (4)

Clinical Research Services Turku CRST

Turku, 20520, Finland

Location

Study Coordinating Investigator

Harleshausen, Kassel, 34128, Germany

Location

Semmelweis Egyetem Neurológiai Klinika

Budapest, 1083, Hungary

Location

Investigator

Riga, LV1012, Latvia

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Stalevo; Levodopa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Aila Holopainen, MSc

  Orion Corporation, Orion Pharma, Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: May 6, 2016
• Study Start: April 8, 2016
• Primary Completion: March 27, 2018
• Study Completion: March 27, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); HU (1); DE (1); LA (1)