EUCTR2004-001593-10-GB进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
- •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
- •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
排除标准
- •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
- •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.]
研究者
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