Treatment-Associated Dyskinesia in Parkinson's Disease
Conditions
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has participated in and completed the previous PADDY 1 or PADDY 2 study. 2. The patient has given his/her informed consent to participate in the PADDY-O study. (Note: The patient must have given written informed consent before any study-related activities are carried out.) 3. Visit 8 of the PADDY study and the first visit of the PADDY-O study are on the same day or, if on different days, they are not separated by a period exceeding one month. 4. (For females of child-bearing potential) The patient is using a reliable method of contraception AND gives a negative result in a serum ß-HCG test for pregnancy at entry into 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: 1. The patient has, within the four weeks up to inclusion, started treatment with any classical or atypical neuroleptics (including metoclopramide) and/or antidepressants and/or anxiolytics (including buspirone). 2. The patient's dosage with any of the medications listed in (1) above has changed within the four weeks up to inclusion. 3. Any commencement or change of dosage with any of the medications listed in (1) above during the study period is anticipated. 4. The patient experienced major tolerability problems during the PADDY study that were/are judged by the investigator as being sufficient to preclude participation in the PADDY-O study. 5. Known hypersensitivity to ACTH. (In establishing this, the investigator should check the patient's records from the PADDY study.) 6. (For female patients) The patient is pregnant or lactating. 7. The patient is participating in another clinical study or has done so within the past 30 days - apart from the PADDY 1 or PADDY 2 study. 8. The patient has relevant renal impairment as measured by creatinine >2 x ULN (upper limit of normal). 9. The patient has relevant hepatic impairment as measured by total bilirubin >2 x ULN or has a history of moderate or severe hepatic insufficiency or has moderate or severe liver cirrhosis. 10. The patient has received neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the study period. 11. The patient has any clinically significant illness that, in the investigator's opinion, might interfere with the patient's ability to participate in the study. 12. The patient showed major non-compliance in respect of intake of study medication during the respective PADDY study. 13. The patient is suffering from dementia, or any other psychiatric illness that prevents him/her from giving informed consent. 14. The patient has legal incapacity or limited legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the long-term safety of Sarizotan HCl 1 mg b.i.d. administered to Parkinson patients with dyskinesia. ;Secondary Objective: To obtain information about the treatment's long-term efficacy and the impact on management of Parkinson's disease (treatment with L-dopa and/or other anti-Parkinson's disease drugs) in patients undergoing the study treatment.;Primary end point(s): There is no primary variable as such. Descriptive statistical methods will be applied; no hypothesis testing will be performed. The objective of the statistical processing will be to provide a summary of the safety data acquired in the course of the study, and to provide corresponding processing of the efficacy data. Safety variables will be: - Adverse events - Withdrawals due to adverse events - Laboratory values (chemistry, hematology, endocrine). - Vital signs Efficacy variables are similar to those in the preceeding PADDY 1 and PADDY 2 studies: - UPDRS (Part IV) sum score of items 32 and 33 - responder rate based on the sum score of items 32 and 33 UPDRS (Part IV) - Variables derived from the subject's diary: time in the state "ON without dyskinesia", time in the state "ON with dyskinesia", severity of dyskinesia (mean vaule of the VAS scores), cumulative VAS scores divided by total ON time, tim in the state OFF, time in the state ASLEEP. - Modified AIMS, at rest and with provoked dyskinesia - Clinical and patient's global impression - UPDRS (Part I to VI) in the "best ON" state, including sub-analysis of Part III. | — |
Countries
Austria, Finland, Italy, Spain, United Kingdom
Outcome results
None listed