A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2

• Conditions: Treatment-Associated Dyskinesia in Parkinson's Disease

• Registration Number: EUCTR2004-001594-25-FI
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1.The subject has given his/her written informed consent to participate in the study.
2.The subject is an out-patient aged 30 years or above.
3.(For female subjects of child-bearing potential) The subject is using a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
4.The subject presents with a diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
5.The subject presents with Stage 2.5 or above on the Hoehn and Yahr staging system.
6.The subject's dyskinesia is present during more than 25% of the waking day (historical information in agreement with the assessment of the investigator according to item 32 of UPDRS).
7.The subject's dyskinesia is at least moderately disabling (historical information in agreement with the assessment of the investigator according to item 33 of UPDRS).
8.The subject has at least 4 ticks/day ON time with dyskinesia” on each of the two days the diary was completed before the inclusion visit.
9.The subject has participated successfully in a diary-card training session.
10.All registered Parkinson drugs are allowed. The subject has been on a stable dose of anti-Parkinsonian drugs except L-dopa for a period of at least 8 weeks up to the screening visit.
11.In the judgment of the investigator based on the subject’s history, previous treatments, and the investigator’s overall knowledge of PD, the subject is considered as being optimally treated at the present time (i.e., further adjustments of current medication will not further improve the subject's symptoms of Parkinson's disease).
12.The subject has at least 4 ticks/day ON time with dyskinesia” on each of the two days the diary was completed before the baseline visit.
13.The subject shows adequate compliance with the instructions for filling in the diary.
14.The subject shows adequate compliance with the schedule for intake of investigational product.

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 subject 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 subject'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.(For female subjects) The subject is pregnant or lactating.
5.The subject is participating in another clinical study or has done so within the past 30 days.
6.The subject has participated in the SPLENDID study (EMR 62 225-001) or the SPIRID study (EMR 62 225-006).
7.The subject has received neurosurgical intervention related to PD (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the study period.
8.The subject has any clinically significant illness that, in the investigator's opinion, might interfere with the subject's ability to participate in the study.
9.The subject has relevant renal impairment as measured by Creatinine >2 X ULN.
10.The subject has relevant hepatic impairment as either measured by total bilirubin > 2 X ULN or by a history of moderate or severe hepatic insufficiency or of moderate or severe liver cirrhosis.
11.The subject is suffering from any dementia or other psychiatric illness that prevents him/her from giving informed consent.
12.The subject has legal incapacity or limited legal capacity.
13.The subject has a history of allergic asthma. (Note: This is to minimize the risk of severe allergic reactions to ACTH following the stimulation test.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified