Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01296464
• Date of registration: 14/02/2011
• Prospective Registration: No
• Primary sponsor: Orion Corporation, Orion Pharma
• Public title: Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens PARTEST
• Scientific title: Duration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off Symptoms
• Date of first enrolment: February 2011
• Target sample size: 27
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01296464
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Finland, Sweden

Contacts

• Name: Vilho Myllylä, Prof
• Affiliation: Oulu Deaconess Instutute

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.

- Duration of response between 1.5 and 4 hours (based on medical history) to the
patient's first morning dose of levodopa/dopa decarboxylase inhibitor (DDCI) with or
without entacapone.

- Treatment with 3-8 daily doses of levodopa/DDCI with or without entacapone with a
total daily levodopa dose in the range of 300-1200 mg. One evening dose of
controlled-release formulation of levodopa/DDCI is allowed provided that it is
included in the total of 3-8 daily doses of levodopa/DDCI mentioned above.

- Unchanged levodopa/DDCI with or without entacapone and other antiparkinsonian
medication(dopamine agonists, monoamine oxidase [MAO] B inhibitor, amantadine and/or
anticholinergics with approved doses), if any, for at least 6 weeks prior to the
screening visit.

- Age of 30 years or above

Exclusion Criteria:

- Secondary or atypical parkinsonism.

- 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 nonselective MAO
inhibitors.

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

- Use of any iron preparations.

- Intensity of dyskinesias which would, in the opinion of the investigator, interfere
with the interpretation of motor part (part III of the Unified Parkinson's Disease
Rating Scale (UPDRS III) scoring during the levodopa challenge test.

- Currently active hallucinations.

- Severe orthostatic hypotension as judged by the investigator.

- Mini-Mental State Examination (MMSE) score < 26

- 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.

- Treatment with levodopa or dopamine agonist infusion or injection

- Active malignancy, narrow-angle glaucoma or pheochromocytoma.

- Clinically significant cardiovascular, pulmonary, gastrointestinal, 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 > upper limit of normal at
screening.

- Any other abnormal value of laboratory, vital signs or electrocardiogra (ECG) which
would 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) if they are not using proper contraception (hormonal contraception,
intrauterine device [IUD] or surgical sterilisation, spermicidal foam in conjunction
with condom on male partner).

- Patients with pre-planned elective surgery.

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

- Participation in a drug study within 60 days prior to entry to this study.

- 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.



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

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Carbidopa

Primary Outcome(s)

Duration of motor response by UPDRS III [Time Frame: 20 minute intervals]

Secondary ID(s)

2939136

Source(s) of Monetary Support

Please refer to primary and secondary sponsors