Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I

EUROBIOTEC GMBH0 sites350 target enrollmentFebruary 13, 2008

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 13, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

EUROBIOTEC GMBH

Eligibility Criteria

Inclusion Criteria

•a)Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
•b)Patient is willing and able to comply with all trial requirements
•c)Male or female outpatients
•d)Age \> 30 years
•e)Patients with newly diagnosed early\-stage of idiopathic Parkinson?s disease for longest 1 year (diagnosis based on the UK Parkinson Brain Bank Diagnostic Criteria for PD, see Appendix 16\.3\.8\) who have not yet received Levodopa therapy (except Levodopa test)
•f)Minimum UPDRS motor score of \> 12 points at Baseline Visit BL
•g)Mini Mental State Examination (MMSE) score of ≥ 27
•h)Concomitant diseases are stable and well controlled by medication
•i)Female patients must have a negative pregnancy test within 7 days prior to or at Baseline and are required to practice an effective method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility. Effective method of birth control is defined as those which result in a low failure rate (i.e. Pearl Index less than 1% per year) when used consistently and correctly such as:
•A hormonal oral, transdermal, or injectable contraceptive agent with a double\-barrier method

Exclusion Criteria

•a)Patient has non\-idiopathic PD due to drugs (e.g. flunarizine, metoclopramide), metabolic neurogenetic disoders (e.g., Wilson?s disease), encephalitis, cerebrovascular disease or other forms of secondary or atypical Parkinsonism such as multisystem atrophy (MSA) or progressive supranuclear palsy)
•b)Significant neurological symptoms not accounted for by Parkinson?s disease
•c)Current diagnosis of epilepsy, history of seizures as an adult, history of stroke, or transitory ischemic attacks (TIA) within one year prior to the screening visit (visit VS)
•d)Patient has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplantation or other neurosurgery for Parkinson?s disease
•e)History of or active hallucinations or delusions including drug\-induced hallucinations, e.g. by dopaminergic therapy
•f)Treatment with dopamine agonists within 28 days of the baseline visit (BL)
•g)Pre\-treatment with Levodopa (except for diagnostic challenge)
•h)Pre\-treatment during the last 3 months prior to baseline visit 2 or current treatment with MAO\-A inhibitors (pargyline, phenelzine, tranylcypromine), reserpine, budipine, alpha\-methyldopa
•i)Current treatment with CNS active therapy (e.g., sedatives, hypnotics, anti\-depressants, anxiolytics, antipsychotics) unless the dose has been stable for at least 28 days prior to the baseline visit (BL) and is likely to remain stable for the duration of Part A of the study.
•j)Current treatment with medications which will be eliminated through the renal tubulus system or which inhibit the active renal tubulus secretion (e.g., cimetidine, amantadine)