SLV308 for Treatment of Patients With Early Parkinson´s Disease
- Conditions
- -G20 Parkinson´s diseaseParkinson´s diseaseG20
- Registration Number
- PER-069-06
- Lead Sponsor
- SOLVAY PHARMACEUTICALS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>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).<br>Timepoints:Week 24.<br>
- Secondary Outcome Measures
Name Time Method