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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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2 August 2021 |
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Main ID: |
EUCTR2004-001594-25-ES |
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Date of registration:
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02/11/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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24/11/2004 |
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Target sample size:
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600 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001594-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Finland
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Spain
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Key inclusion & exclusion criteria
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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 potencial) 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 for 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, with 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 paticipate 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 >2x 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 minimaze the risk of severe allergic reactions to ACTH following the stimulation test).
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Treatment-Associated Dyskinesia in Parkinson's Disease
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Intervention(s)
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Product Name: Sarizotan
Product Code: EMD 128130
Pharmaceutical Form: Tablet
INN or Proposed INN: Sarizotan Hydrochloride
CAS Number: 195068-07-6
Current Sponsor code: EMD128130
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to demonstrate efficacy of 1 mg Sarizotan HCl b.i.d. after 12 weeks and after 24 weeks (maintenance of efficacy) in the treatment of dyskinesia in Parkinson's disease.
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Primary end point(s): A subject is defined as a responder if he improves at least 25 % in the sum score of item 32 and 33 of the UPDRS compared to baseline at visit 3.
The primary target variable is defined as a responder rate assessed at visit 5 (Endpoint 1) and at visit 7 (Endpoint 2).
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Secondary Objective: The secondary objective of this study is to collect safety and tolerability data for 1mg Sarizotan HCl b.i.d in Parkinson patients.
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Secondary ID(s)
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2004-001594-25-FI
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EMR62225-019
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 27/10/2004
Contact:
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