Parkinson's Disease Early Stage
Conditions
Interventions
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Pharmaceutical Form: Film-coated tablet
Other descriptive name: SLV308 (mono) hydrochloride
Concentration unit: mg m
Sponsors
Solvay Pharmaceuticals
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 UKPDS Brain Bank criteria (see Appendix ?16.3) - Modified Hoehn and Yahr up to 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 of more than 30 years old - For anti-PD medication other than SLV308, the following criteria apply: - subjects may have had treatment with 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 for at least 90 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 and dopamine agonists (i.e. selegiline, rasagiline, anti-cholinergics, amantadine) is allowed if the doses have been kept stable for at least 28 days prior to baseline and will be kept stable 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 - Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes (e.g. multiple system atrophy, progressive supranuclear palsy) or heredodegenerative diseases. - Subjects who have undergone surgery for the treatment of PD (e.g. pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery. - Presence of dyskinesias, motor fluctuations or loss of postural reflexes. - Subjects with a history of non-response (according to both the clinician and the subject) to an adequate course of L-dopa or a dopamine agonist. - Subjects for whom previous treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and/or sleep attacks. - Treatment within 60 days prior to baseline with monoamine oxidase (MAO) inhibitors (other than selegiline and rasagiline), 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. General - Exposure to any investigational drug within 60 days prior to Visit 1. - Breast feeding or pregnant women. - Prior exposure to SLV308. - Uncooperative attitude or reasonable likelihood for non-compliance with the protocol. - Any other reason that, in the investigator’s opinion, prohibits the inclusion of the subjects into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide six months pivotal efficacy data to show that 12 – 42 mg/day SLV308 monotherapy is superior to placebo with respect to the motor functioning of Parkinson’s disease (PD) patients.;Secondary Objective: The secondary objectives are: - to establish that at least one of the selected fixed doses of 6 mg/day or 12 mg/day SLV308 is significantly more efficacious than placebo (minimum effective dose) - to investigate the effects of treatment with SLV308 compared to placebo in improving overall PD symptoms, including activities of daily living (ADL) and clinical global impression (CGI) - to collect and evaluate data on population-pharmacokinetics of SLV308 - to investigate the effects of SLV308 treatment on quality of life. The safety objective is to assess safety and tolerability of SLV308 monotherapy in patients with early stage PD. ;Primary end point(s): Efficacy: UPDRS parts 1, 2 and 3, CGI Severity (CGI-S), CGI Improvement (CGI-I) and Parkinson’s Disease Questionnaire (PDQ-39). Pharmacokinetics: Data obtained on population pharmacokinetics of SLV308. Safety: Adverse events (AEs), vital signs, physical examination, electrocardiogram (ECG) and laboratory assessments. | — |
Countries
Finland, Slovakia, Sweden
Outcome results
None listed