Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1

Axxonis Pharma AG0 sites350 target enrollmentNovember 29, 2006

Overview

No summary available.

Registry

who.int

Start Date

November 29, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Male or female outpatients
•Age of \> 30 years
•Newly diagnosed early\-stage of idiopathic Parkinson’s disease (diagnosis based on the UK Brain Bank Criteria) with less than 4 years history of motor symptoms
•No previous Levodopa or dopamine agonist therapy (Overall treatment duration for Levodopa products may not exceed 4 weeks, for dopamine agonists 3 months).
•Minimum UPDRS motor score of \> 12 points.
•Mini Mental State Examination (MMSE) score of \= 27\.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•a) Patient has non\-idiopathic PD
•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) 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 hallucina\-tions, e.g. by dopaminergic therapy
•f) Any dopamine agonist or Levodopa treatment within 28 days of the baseline visit (BL)
•g) Overall treatment duration for Levodopa products may not exceed 4 weeks, for dopamine agonists 3 months
•h) Pre\-treatment during the last 3 months prior to baseline visit 2 or current treatment with MAO\-A inhibitors, reserpine, budip\-ine, alpha\-methyldopa
•i) Current treatment with CNS active therapy unless the dose has been stable for at least 28 days prior to the baseline visit (BL). Current treatment with antipsychotics is not allowed and must be discontinued at least six months prior to baseline.
•j) Current treatment with medications eliminated through the renal tubulus system or which inhibit the active renal tubulus secretion; to be discontinued at least seven days prior to baseline