None listed
Conditions
Interventions
GROUP 1 Type of group
Flexible Qualification Period: Duration of 4 to 7 weeks. This group will be titrated at a dose of 6 mg / day of SLV308, PO, QD in the first 2 weeks. And for the remaining 5 weeks of this period, fictitious increases of the dose will be made to maintain the blind.
Maintenance Period: Duration of 24 weeks. This group will continue with the established dose of SVL 308 of 6 mg / day, PO, QD.
Group name:GROUP 4 Type of group
Flexible Qualification Period: Duration of 4 to 7 weeks. This group will be treated with SVL 308 Placebo, PO, QD, simulating a dose increase during the whole of this period.
Maintenance Period: Duration of 24 weeks. This group will continue with SVL 308 Placebo PO, QD, without further modification.
Sponsors
SOLVAY PHARMACEUTICALS,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who give written informed consent before initiating any specific procedure of the study. 2. The clinical diagnosis of the subjects must meet the diagnostic criteria of idiopathic Parkinson´s disease. 3. Until stage 3 of the modified Hoehn and Yahr scale. 4. The motor score of the Unified Parkinson´s Disease Rating Scale (UPDRS) (part 3) must be a total of at least 10 in the baseline assessment. 5. Outpatient patients. 6. Subjects ≥ 30 years of age. 7. For antiparkinsonian medication, except SLV3P8, the following criteria will be applied: a) Subjects may have received treatment with formulations of L-dopa or dopamine agonists for a total of up to 90 days. b) Subjects must have discontinued the use of L-dopa and / or dopamine agonists for at least 90 days before the baseline evaluation. c) Effective pre-treatment can not be interrupted for the sole purpose of enrolling the subject in the study. d) Concomitant antiparkinsonian treatment other than L-dopa and dopamine agonists may be administered if the doses have been stable for at least 28 days before the baseline assessment and during the study. 8. Men and women; women should not have the potential to procreate, or: a) Must present a negative test for human chorionic gonadotropin B and b) Use an accepted contraceptive method.
Exclusion criteria
Exclusion criteria: 1. The diagnosis is not clear or there are suspicions of other parkinsonian syndromes. 2 Subjects who underwent surgery for the treatment of PD or who underwent any other brain surgery. 3. Presence of dyskinesias, motor fluctuations or loss of postural reflexes. 4. Subjects with a history of lack of response to an adequate treatment of L-dopa or a dopamine agonist. 5. Subjects in whom the previous treatment with dopamine agonists due to induction of psychosis and / or sleep attacks should have been discontinued. 6. Treatment within 60 days prior to the baseline assessment with monoamine oxidase inhibitors, alpha-methyldopa or metoclopramide, treatment within 30 days prior to baseline evaluation with parenteral ergots, methylphenidate, amphetamine, beta-blockers to treat tremors, isoprenaline , adrenaline, dopamine, dobutamine, reserpine, flunarizine or cinnarizine. 7. Current diagnosis or history of drug or alcohol abuse within 12 months prior to Visit 1. 8. Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses. 9. Subjects that are considered to be violent or subjects considered to be suicidal. 10. Other psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study. 11. History of hallucinations, psychosis and / or treatment with antipsychotics within one year prior to the baseline evaluation. 12 History or presence of seizure disorders and subjects that require treatment with anticonvulsants. 13. Subjects with symptomatic brain disease focal neurological lesions or any acute brain trauma that requires treatment with anticonvulsant therapy. 14. Clinically significant abnormal laboratory data, at Visit 1, or any abnormal laboratory values ​​that could interfere with the evaluation of safety or efficacy. 15. Current evidence of a hematological, autoimmune, endocrine, cardiovascular, renal or gastrointestinal disorder that is clinically significant. 16. Subjects whose current medication regimen or condition suggests they will not remain constant during the study participation. 17. Known unstable insulin-dependent diabetes mellitus or an oral antihyperglycemic agent for less than 28 days before the baseline evaluation. 18. Any malignant disease or a history of neoplasia, except in situ carcinoma of the cervix or basal cell carcinoma of the skin. 19. History of gastrointestinal, hepatic, renal or other known condition that could interfere with the absorption, distribution, metabolism or excretion of the medication and / or the study evaluations. 20. Clinically relevant ischemic heart symptoms or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty. 21. Subjects with unstable hypertension or symptomatic hypotension or orthostatic hypotension. In addition, subjects with a history of repeated vasovagal syncope should also be excluded. 22. Subjects should be excluded when vital signs show abnormal values ​​that are considered clinically significant in the selection. 23. Subjects with evidences in the ECG of: a) Fibrillation / atrial flutter. b) Prolonged QTc. c) Complex premature ventricular contractions. d) Clinically relevant conduction disorders. 24. Hypersensitivity or known contraindication to the use of serotonergic agents or dopamine agonists. 25. Ex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The UPDRS motor examination is the third part of this scale and evaluates with scores from 0 to 4 the following areas: Speech, facial expression, tremor at rest, action or postural tremor! of the hands, Stiffness, Touching the fingertips, Hand movements, Fast alternating movements of the hands, Agility in the leg, Rising from a chair, Posture, March, Postural stability and Bradykinesia and body hypokinesis. Measure:Change from the baseline assessment to the maintenance / end point of week 24 on the motor score of the Unified Parkinson s Disease Rating Scale (UPDRS). Timepoints:Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Part 2 of the UPDRS: Evaluation of activities of daily living, which is based on the evaluation of the following: Speech, Salivation, Swallowing, Writing, Cutting food and utensils, Dressing, Hygiene, Rotate in bed and lay the sheets, falls, freezing when walking, walking, trembling and sensory disturbances related to parkinsonism. 2) CGI-I: This section of the CGI will evaluate with a score of 1 to 7 the clinical baseline status. 3) PDQ-39: It is a questionnaire of 39 questions, each of which may be qualified from 0 to 4 depending on the response chosen by the patient. Measure:Secondary efficacy: 1) Change from the baseline assessment of the score of part 2 of the UPDRS. 2) Change from the baseline evaluation of the Clinical Global Impression of Improvement score (CGI-I). 3) Change from the baseline assessment of the total score of the Parkinson s Disease Questionnaire (PDQ-39) in the week 24 maintenance visit. Timepoints:Week 24. ; Outcome name:1) UPDRS Parts 1, 2 and 3: In each of the parts different functions are evaluated, each of which is scored with a score of 0 to 4. Part 1 refers to mental state, behavior and humor, the part 2, activities of daily life and part 3, motor examination. 2) PDQ-39: It is a questionnaire of 39 questions, each of which can be classified from 0 to 4 depending on the response chosen by the patient. 3) CGI: It is an evaluation of the overall clinical impression with respect to improvement and severity. 4) Rate of responders: Evaluation of the number of patients who achieved a decrease of ≥ 20% from the baseline assessment of the UPDRS motor score. Measure:Other efficacy criteria: 1) Changes from the baseline assessment in part 1, parts 2 + 3, parts 1 + 2 + 3 of the UPDRS. 2) Changes from the baseline evaluation of the scores of the eight subscales of PDQ-39. 3) Changes from the baseline assessment of the CGI severity score. 4) Rate of responders. Timepoints:Week 24. | — |
Countries
Argentina, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Finland, India, Israel, Mexico, New Zealand, Peru, Romania, Serbia, Slovakia, South Africa, Sweden, Ukraine, United States
Outcome results
None listed