None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with SLV308, in capsules, BID, PO, the dose will be adjusted progressively during 4 - 7 weeks (Adjustment period), from 0.3 mg per day until achieving a dose of 12 - 42 mg per day. The dose obtained during the adjustment period will be stabilized for 2 weeks (Stabilization period). Finally, long-term treatment for 3 months with the optimal dose will be continued, according to the clinical response (Maintenance Period). During all this time, patients will be treated wit
This group will be treated with SLV308 Placebo, in capsules, BID, PO, the dose will be adjusted, simulated, progressively during 4 - 7 weeks (Adjustment period). The dose obtained during the adjustment period will be stabilized, simulated, for 2 weeks (Stabilization period). Finally, long-term treatment for 3 months with the optimal dose will be continued, according to the clinical response (Maintenance Period). During all this time, patients will be treated with L-Dopa, with scheme and dose acc
Sponsors
SOLVAY PHARMACEUTICALS,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The clinical diagnosis of the subjects must meet the criteria of Diagnosis of Idiopathic Parkinson´s Disease according to the criteria of the Brain Bank of the Parkinson´s Disease Society of the United Kingdom (UKPDS). 2. Stage 2-4 of the EP disease in the OFF state according to the modified Hoehn and Yahr classification of disease severity. 3. Stable treatment with L-dopa at least 28 days before. 4. Presence of recognizable ON and OFF status (motor fluctuations). 5. Minimum OFF time per day of 2.5 hours. 6. Subjects ≥ 30 years of age. 7. Ability to keep a diary at home to record ON / OFF symptoms and dyskinesias. 8. For antiparkinsonian medication, except SLV308, the following criteria will apply: a) Previous treatment with dopamine agonists must have been discontinued at least 90 days before. b) Effective previous treatment with dopamine agonists for the sole purpose of enrolling the subject in this study can not be interrupted. c) Concomitant antiparkinsonian treatment other than L-dopa may be administered if the doses have been stable for at least 28 days before the baseline assessment and during the study. 9. Outpatients. 10. Men and women; women should not have the potential to procreate, or either: a) They must present a negative test for human chorionic gonadotropin B and b) Use an accepted method of contraception.
Exclusion criteria
Exclusion criteria: unrelated to the administration times of L-dopa. 2. Prevalent expression of severely disabling dyskinesias during daytime vigil. 3. The diagnosis is not clear or there are suspicions of other parkinsonian syndromes. 4. Subjects who underwent surgery for the treatment of PD. 5. Subjects in whom the previous treatment with dopamine agonists in the previous year had to be discontinued. 6. Current diagnosis or history of drug or alcohol abuse within the previous 12 months. 7. Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses. 8. Subjects that, based on the antecedents and the examination of the mental state, are considered as violent or subjects considered in suicidal risk. 9. Other psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study. 10. History of hallucinations, psychosis and / or treatment with antipsychotics for any indication within the previous year. 11. Antecedents or presence of convulsive disorders and subjects that require treatment with anticonvulsants. 12. Subjects with known serious symptomatic brain disease, cerebrovascular disease, focal neurological lesions or any acute cerebral trauma that requires treatment with anticonvulsant therapy at the time of entering the study. 13. Abnormal laboratory data, clinically significant. 14. Current evidence of a hematological, autoimmune, endocrine, cardiovascular, renal or gastrointestinal disorder that is clinically significant. 15. Subjects whose current medication regimen or condition suggests they will not remain constant during the study participation. 16. Known unstable insulin-dependent diabetes mellitus or subjects receiving oral anti-hypoglycaemic agents for less than 28 days before. 17. Any malignant disease or a history of neoplasia. 18. Presence or history of gastrointestinal, hepatic, renal or other known condition that could interfere with the absorption, distribution, metabolism or excretion of medication and / or study evaluations. 19. Clinically relevant ischemic heart symptoms present at the time of entry into the study and / or a history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty in the previous year. 20. Subjects with unstable hypertension, symptomatic hypotension or orthostatic hypotension. 21. Subjects should be excluded when vital signs show abnormal values that are considered clinically significant. 22. Subjects with evidence in the ECO of: a) Fibrillation / atrial flutter. b) Prolonged QTc. c) Complex premature ventricular contractions. d) Clinically relevant conduction disorders. 23. Hypersensitivity or known contraindication to the use of serotonergic agents or dopamine agonists. 24. Treatment with prohibited medication. 25. Exposure to any investigational drug within the previous 60 days. 26. Women who are breastfeeding or pregnant. 27. Previous exposure to SLV308. 28. Illiterate patients. 29. Attitude of non-cooperation or reasonable likelihood of not complying with the protocol. 30. Any other reason that, in the investigator´s opinion, does not allow the subjects to be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The periods of dose-dependent motor fluctuations (OFF times) will be recorded in the Journals of the subjects completed at home. Measure:Change from the baseline assessment to the maintenance visit in the mean OFF time in patients with PD receiving L-dopa. Timepoints:Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Periods of adequate motor stability (ON times), without dyskinesias that, due to their duration, degree of disability, degree of pain and / or presence of morning dystonia are considered problematic, will be recorded in the journals of the subjects completed. at home. Criterion 2: The Unified Parkinson s Disease Rating Scale (UPDRS), specifically, the sum of Parts 2 and 3; Part 2 will be the average of the state ON and OFF and Part 3 will be measured during the ON state. Criterion 3: The Parkinson s Disease Questionnaire (PDQ-39) is a self-administered questionnaire comprising 39 items that encompass eight health domains that the subjects consider to be adversely affected by the disease. Measure:1) Change from the basal evaluation in the ON time without problematic dyskinesias. 2) Change from the baseline assessment in the sub-score of the UPDRS. 3) Change in the total score of the PDQ-39. Timepoints:Criteria 1 and 2: Weeks 3, 9, 13, 21 and at the end of treatment. Criterion 3: Weeks 0, 13, 21 and at the end of treatment. ; Outcome name:Criterion 1: The Hospital Anxiety Score (HADS) consists of 14 items, seven of which assess depression and seven others, anxiety. Criteria 2 and 3: Journal of the patient. Criteria 4, 5 and 7: The Global Clinical Impression (CGI) evaluates the general clinical condition of the subject Criterion 6: The Parkinson s Disease Questionnaire (PDQ-39) is a self-administered questionnaire comprising 39 items covering eight domains of health that the subjects consider to be adversely affected by the disease. Measure:1) Change from the baseline in the total score and subscores of the HADS. 2) Change in time ON with problematic dyskinesias. 3) Change in the daily dose of L-dopa. 4) CGI - severity and CGI - improvement. 5) Changes from the baseline in the UPDRS scores for Parts 1, 2, 3 and 4 separately. 6) Change from the baseline in the sub-scores of PDQ-39. 7) Change from baseline in pain | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Latovia, Lithuania, Peru, Russian Federation, Ukraine, United States
Outcome results
None listed