An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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