Early Stage Parkinson’s Disease MedDRA version: 9.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's
Conditions
Interventions
Product Name: Pardoprunox
Product Code: SLV308
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Pardoprunox hydrochloride
CAS Number: 269718-83-4
Current Sponsor code: Pardoprunox hydrochl
Sponsors
Solvay Pharmaceuticals B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The clinical diagnosis of subjects must meet the criteria for "Diagnosis of idiopathic Parkinson’s Disease" according to the modified United Kingdom Parkinson’s Disease Society Brain Bank criteria. - Modified Hoehn and Yahr up to and including stage 3. - Unified Parkinson’s Disease Rating Scale (UPDRS) motor score (part 3) must have a total of at least 10 at baseline - Out patients. - Subjects between the age of = 30 and = 80 years. - For anti-PD medication other than pardoprunox, the following criteria apply: - subjects may have had treatment with levodopa (L-dopa) formulations or dopamine agonists up to a total of 90 days; - subjects must have stopped the use of L-dopa and/or dopamine agonists and amantadine for at least 30 days prior to baseline; - efficacious previous treatment is not allowed to be stopped for the sole purpose of enrolling the subject into this study; - concurrent anti-PD treatment other than L-dopa, dopamine agonists and amantadine (i.e., selegiline, rasagiline, anti-cholinergics) is allowed if the doses have been kept stable for at least 30 days prior to baseline and during the study. 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: Related to Parkinson’s Disease 1.Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary parkinsonism, Parkinson-plus syndromes or heredodegenerative diseases. 2.Subjects who have undergone surgery for the treatment of PD or have undergone any other brain surgery at any time. 3.Subjects with a history of non-response to an adequate course of L-dopa or a dopamine agonist. 4.Subjects for whom previous treatment with dopamine agonists needed to terminate because of induction of psychosis and/or sleep attacks. 5.Treatment within 60 days prior to baseline with monoamine oxidase inhibitors, alpha methyldopa or metoclopramide; treatment within last 30 days before baseline with parenteral ergots, methylphenidate, amphetamine, beta blockers for treating tremor, isoprenaline, adrenaline, dopamine, dobutamide, reserpine, flunarizine or cinnarizine. Related to Psychiatric and Neurological Disorders 6.Current diagnosis or history of drug or alcohol abuse, within 12 months prior to screening visit. 7.Lifetime history of primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, such as schizophrenia or bipolar disorder. 8.History of a major depressive disorder within the 12 months prior to the screening visit. 9.Subjects who, based on history and mental status examination, are considered to be violent, or subjects considered at suicidal risk by the Investigator. 10.Other psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study. Cognitive impairment, dementia, or other unstable and/or progressive neurological disorder. 11.A history of hallucinations, illusions, vivid dreams, psychosis and/or treatment with antipsychotics for any indication within a year from baseline. 12.A history of, or current, seizure disorders and subjects requiring treatment with anti-convulsants for epilepsy. 13.Subjects known with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions or any acute brain trauma currently requiring treatment. Related to Other Medical Conditions 14.Clinically significant abnormal laboratory data at screening visit or any abnormal laboratory value that could interfere with the assessment of safety or efficacy. 15.Hypokalemia and/or hypomagnesemia. 16.Current evidence of clinically significant hematological, autoimmune, endocrine, cardiovascular, renal or gastrointestinal disorder that would possibly interfere with the subject’s participation in the study. 17.Subjects whose current regimen of medication or condition suggests that it will not remain stable for the duration of study participation will be excluded from the trial. 18.Known unstable insulin dependent diabetes mellitus or on oral hypoglycemics for less than 30 days prior to baseline. 19.Any malignant disease or a history of neoplasms, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin. 20.A history of, or a known current gastrointestinal, liver, kidney or other known condition, which may interfere with the absorption, distribution, metabolism or excretion of the study medication and/or assessments. 21.Clinically relevant ischemic heart symptoms or history of myocardial infarction coronary artery bypass surgery or percutaneous transluminal coronary angioplasty. 22.Subjects with unstable hypertension or symptomatic hypotension, or orthostatic hypotension which is defined as a decrease of 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to explore the effective and tolerable dose range of pardoprunox monotherapy in patients with early stage Parkinson’s disease.;Secondary Objective: The secondary objectives are: -to estimate the minimum effective dose of pardoprunox monotherapy; -to compare the effect size of pardoprunox with pramipexole and placebo for assay sensitivity; -to collect and evaluate data on population-pharmacokinetics of pardoprunox. The safety objectives are: -to assess the safety and tolerability of different doses of pardoprunox monotherapy in patients with early stage PD; -to determine the optimum titration schedule to the effective doses. ;Primary end point(s): the change from baseline to Week 4/endpoint of the maintenance period of the UPDRS part 3 score of pardoprunox groups compared to placebo | — |
Countries
Slovakia
Outcome results
None listed