Early Parkinson's Disease MedDRA version: 8.1 Level: PT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Product Name: Lisuride TTS 10cm²
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: LISURIDE
CAS Number: 18016803
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Axxonis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 k) History or presence of dementia l) Presence of major depression m) Presence of clinically relevant fibrosis or other clinically relevant cardiac valvulopathy that is suspicious to progress significantly or history of any other cardiac disor-der which would put the patient at risk of clinically relevant arrhythmia and/or myocardial infarction, within the last 12 months n) Clinically relevant hepatic dysfunction o) Clinically relevant renal dysfunction p) History of syncope and/or severe otherwise symptomatic orthostatic hypotension within the last year or a systolic blood pressure less than 105 mmHg at Screening Visit VS q) History of significant skin hypersensitivity to adhesive or other transdermal applications, or recent unresolved contact dermatitis r) Any medical or psychiatric condition or any other clinically significant laboratory abnormalities that, in the opinion of the investigator, would interfere with the ap-propriate conduct of the study s) Alcohol or drug abuse in the past three years t) Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating and/or who are unwilling to use effective means of contracep-tion u) Patient has previously participated in this trial or patient has previously been as-signed to treatment in a trial with Lisuride TTS v) Participation in other clinical studies in the previous four weeks w) Pregnancy or lactation x) QTc > 470 ms at Visit 1 (Bazett correction must be used) y) Known hypersensitivity to Pramipexole and/or Lisuride z) Creatinine clearance estimated according to Cockroft and Gault < 30 ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) To investigate the superior efficacy of an optimized individual dose of transdermal Lisuride against placebo after 26 weeks, using a sum score of UPDRS parts II (activity of daily living) and III (motor symptoms). (2) To demonstrate non-inferior efficacy of optimized individual dosages of transdermal Lisuride compared with oral Pramipexole after 26 weeks, using a sum score of UPDRS parts II and III. (3) To investigate superior efficacy of optimized individual dosages of transdermal Lisuride compared to oral Pramipexole after 26 weeks, using a sum score of UPDRS parts II and III. (4) To investigate superior efficacy of optimized individual dosages of transdermal Lisuride compared to oral Pramipexole after 26 weeks, using the PDSS total score (sleep scale). ;Secondary Objective: The secondary study objectives are: • to evaluate further efficacy criteria, quality of life, tolerability and safety of Lisuride TTS patch treatment in comparison to placebo and Pramipexole af-ter 26 weeks of double-blind treatment; • to evaluate efficacy criteria, quality of life, tolerability and safety of Lisuride TTS patch after 26 week open-label treatment between week 27 and week 52) by comparing two treatment regimens with the Lisuride patch (every second day vs. twice a week) as well as with the pooled data. ;Primary end point(s): Change from baseline to end of treatment in the double-blind period in the combined total score of the UPDRS parts II and III. | — |
Countries
Germany, Italy, Poland
Outcome results
None listed