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 - PARTEST

Orion Corporation0 sites27 target enrollmentNovember 18, 2010

Overview

No summary available.

Registry

who.int

Start Date

November 18, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Written informed consent (IC) obtained.
•2\.Male or female patients with idiopathic PD according to the United Kingdom brain bank criteria with end\-of\-dose motor fluctuations
•3\. Hoehn and Yahr stage 2\-4 performed during the ON” state.
•4\. 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.
•5\. 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.
•6\. 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.
•7\. Age of 30 years or above.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\. Secondary or atypical parkinsonism.
•2\. Use of tolcapone within 6 weeks prior to the first treatment period.
•3\. Previous tolerability problems with entacapone or tolcapone.
•4\. Concomitant treatment with apomorphine, MAO\-A inhibitors or non\-selective MAO inhibitors.
•5\. 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.
•6\. Use of any iron preparations.
•7\. 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.
•8\. Currently active hallucinations.
•9\. Severe orthostatic hypotension as judged by the investigator.
•10\. Mini\-Mental State Examination (MMSE) score \< 26