E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment-Associated Dyskinesia in Parkinson's Disease |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the long-term safety of Sarizotan HCl 1 mg b.i.d. administered to Parkinson patients with dyskinesia. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |