Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease.

• Register: EUCTR
• Last refreshed on: 27 May 2013
• Main ID: EUCTR2010-022200-46-DE
• Date of registration: 13/04/2011
• Prospective Registration: Yes
• Primary sponsor: Orion Corporation
• Public title: Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease.
• Scientific title: Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022200-46
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Finland, Germany, Latvia, Lithuania

Contacts

• Name: [e-mail]
• Affiliation: Orion Corporation Orion Pharma

• Name: [e-mail]
• Affiliation: Orion Corporation Orion Pharma

Key inclusion & exclusion criteria

Inclusion criteria:
• Written informed consent (IC) obtained.
• Male or female patients with idiopathic PD according to the United Kingdom brain bank criteria with end-of-dose -motor fluctuations.
• Hoehn and Yahr stage 2-4 performed during the ON state.
• An average of ?3.0 hours of OFF-time, with a minimum of 0.5 hours of OFF-time on each day (using PD home diary [hereafter diary] ) on 3 consecutive days before the decision of entry.
• Treatment with 3-8 regular daily doses of levodopa/DDCI with entacapone (either levodopa/DDCI combined with Comtess®/Comtan® or as Stalevo®) or without entacapone, including daily use of soluble levodopa formulation, with a total daily levodopa dose in the range of 400-1400 mg. One evening dose of controlled-release formulation of levodopa/DDCI is allowed providing that it is included in the total daily levodopa dose in the range of 400 - 1400 mg mentioned above. Use of additional soluble levodopa formulations as rescue treatment, such as Madopar LT or Quick, up to a maximum of 4 doses per week is allowed; however, its use should be avoided on days during which PD status (diary) is recorded. The levodopa dose from these rescue soluble levodopa formulations is not included in the range of total regular daily dose of levodopa indicated above.
• Unchanged levodopa/DDCI 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 prior to the screening visit.
• Age of 30 years or above.

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
• Secondary or atypical parkinsonism.
• Current use of tolcapone (within 6 weeks prior to the first treatment period).
• Previous tolerability problems with entacapone or tolcapone.
• Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors.
• Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also dopamine D2 receptor blocking antiemetics except domperidone). As an exception to the prohibition of use of antipsychotic drugs, 1 evening dose of an atypical antipsychotic is allowed.
• Severe dyskinesias as judged by the investigator; however, mild to moderate dyskinesia not significantly affecting patient’s activities of daily living is allowed.
• Currently active hallucinations.
• Severe orthostatic hypotension as judged by the investigator.
• Current dementia (Mini-Mental State Examination [MMSE] score < 24).
• Problematic impulse control disorders (ICD) such as pathological gambling, hypersexuality or compulsive shopping within 6 months prior to the screening visit.
• History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
• Past or current treatment with deep brain stimulation (DBS) or other surgical treatment for PD.
• Narrow-angle glaucoma or pheochromocytoma.
• Any active malignant cancer.
• Patients with pre-planned elective surgery that is likely to change or impact on the control of PD symptoms, or involve hospitalization.
• Failure to demonstrate acceptable/appropriate use of the diary, despite adequate training, during the screening visit or other separate training sessions during the screening period.



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
MedDRA version: 14.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: ODM-101
Product Code: 75
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Current Sponsor code: na
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
INN or Proposed INN: CARBIDOPA
CAS Number: 38821-49-7
Current Sponsor code: na
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 65-
INN or Proposed INN: ENTACAPONE
CAS Number: 130929-57-6
Current Sponsor code: na
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: ODM-101
Product Code: 100
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Current Sponsor code: na
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: CARBIDOPA
CAS Number: 38821-49-7
Current Sponsor code: na
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 65-
INN or Proposed INN: ENTACAPONE
CAS Number: 130929-57-6
Current Sponsor code: na
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: ODM-101
Product Code: 125
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Current Sponsor code: na
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
INN or Proposed INN: CARBIDOPA
CAS Number: 38821-49-7
Current Sponsor code: na
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 65-
IN

Primary Outcome(s)

Primary end point(s): PD status will be recorded by using a diary. The patient (or a carer on behalf of the patient) will record whether the patient is OFF, ON without dyskinesia, ON with non-troublesome dyskinesia, ON with troublesome dyskinesia or asleep in 30 minutes time slots (except during sleep time) for 3 consecutive days before randomisation and for 3 consecutive days, starting 26 (+6) days after visits 1, 3 and 5 (i.e. weeks 0, 4 and 8).

Main Objective: The primary objective of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson’s disease (PD) patients with end-of-dose motor fluctuations.

Secondary Objective: The secondary objectives of the study are to get initial data on switching patients from levodopa/dopa decarboxylase inhibitor (DDCI) with or without entacapone directly to ODM-101, to determine the size of therapeutic effect and to study levodopa daily dose and dosing frequency of the combination.

Timepoint(s) of evaluation of this end point: Weeks 0, 4, 8.

Secondary Outcome(s)

Secondary end point(s): UPDRS I-IV, Swab and England activities of daily living scale.

Timepoint(s) of evaluation of this end point: Weeks 0, 4, 8 and 12.

Secondary ID(s)

2010-022200-46-FI

2939135

Source(s) of Monetary Support

Orion Corporation