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 1) - PADDY 1
- Conditions
- Treatment-Associated Dyskinesia in Parkinson's Disease
- Registration Number
- EUCTR2004-001593-10-GB
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 (at visit 2).
9. The subject has participated successfully in a diary-card
training session.
10. 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 visit 3.
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 study medication
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
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 × ULN.
10. The subject has relevant hepatic impairment as either measured by total
bilirubin > 2 x ULN or has a history of moderate or severe hepatic insufficiency
or has 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method