A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND

EISAI LTD UK0 个研究点目标入组 900 人开始时间: 2007年9月7日最近更新: 2012年4月18日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 900

研究概览入排标准研究者记录与标识符相似试验

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

性别: All

入选标准

•1. Male or female patients with idiopathic PD fulfilling the (UK) Parkinson?s
•disease Society Brain Bank diagnostic criteria, with a good response to
•2. Patients must have been diagnosed with idiopathic PD at ≥ 30 years of age.
•3. Patients must have predictable motor fluctuations of the wearing OFF type with
•the presence of at least 2 hours of OFF time during the waking day (excluding
•the morning OFF time) as evidenced by diary cards completed at screening and
•confirmed by diary data collected at the baseline visit.
•4. Before patients are randomised they must be able to show that they are able to
•accurately complete the diary cards. During the diary-training period at the
•initial screening visit there must be diary evidence of at least one transition of
•OFF to ON or from ON to OFF and patients must show 75% concordance with
•Investigator?s completion of the diary card.
•5. Patients must rate between II-IV on the Hoehn &Yahr scale when in an OFF
•6. Patients must be taking optimised levodopa therapy (according to investigator?s
•opinion) at least 3 times during the waking day (not including bedtime/night
•time dose) up to a maximum of 8 doses daily (includes bedtime/night time
•7. Patients who are treated with dopamine agonists, COMT inhibitors or MAOB
•inhibitors and other anti-PD drugs must be on optimised and stable doses for at
•least 4 weeks prior to initial screening visit and must remain stable throughout
•the study. Only levodopa dosage can be adjusted downwards in the first 8
•weeks of the double-blind treatment phase.
•8. In the Investigator?s opinion patients must be able to distinguish their own
•motor states and the absence or presence of troublesome or non-troublesome
•dyskinesias.
•9. In the Investigator?s opinion patients are able to complete the study including
•the completion of the home diary cards and capable of giving full written
•informed consent.
•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. Pregnant or lactating women.
•2. Women of child bearing potential unless infertile (including surgically sterile)
•or practicing effective contraception (e.g. abstinence, IUD or barrier method
•plus hormonal method). These patients must have a negative serum β-HCG test
•at the initial screening visit (Visit 1), and a negative urine pregnancy test at the
•Baseline visit (Visit 3). These patients must also be willing to remain on their
•current form of contraception for the duration of the study. Postmenopausal
•women may be recruited but must be amenorrhoeic for at least 1 year to be
•considered of non-child bearing potential as determined by the investigator.
•3. Fertile men not willing to use reliable contraception and fertile men with
•partners not willing to use reliable contraception.
•4. Patients with a past or present history of drug or alcohol abuse as per DSM IV
•5. Patients with a past (within one year) or present history of psychotic symptoms
•requiring antipsychotic treatment. Patients may be taking anti-depressant
•medication, however the dose must be stable for 4 weeks prior to the baseline
•visit. Use of anti-psychotic medication including clozapine and quetiapine is
•prohibited even if the indication is for movement disorders.
•6. Patients with a past (within one year) or present history of suicidal ideation or
•suicide attempts.
•7. Patients with unstable abnormalities of the hepatic, renal, cardiovascular,
•respiratory, gastro-intestinal, haematological, endocrine or metabolic systems
•which might complicate assessment of the tolerability of the study medication.
•8. Patients with significantly elevated liver enzymes (abnormal bilirubin or serum
•transaminase levels of more than 1.5 times the upper normal limit).
•9. Patients with current or prior treatment (within 4 weeks prior to the baseline
•visit) with medication known to induce the enzyme cytochrome P450 3A4
•(refer to section 8.7.2 for list of prohibited meds).
•10. Current or prior treatment (within 4 weeks prior to the baseline visit) with
•tolcapone, methyldopa, budipine, reserpine, seroquel or intermittent use of
•either liquid forms of levodopa or subcutaneous apomorphine.
•11. Patients with previous stereotactic surgery (eg pallidotomy) for Parkinson?s
•disease or with planned stereotactic surgery during the study period.
•12. Patients receiving or with planned (next 6months) deep brain stimulation.
•13. Patients who have received an investigational product within 4 weeks prior to
•the baseline visit or patients that have participated in a previous study with
•14. Patients with clinically significant cognitive impairment (MMSE <24 and /or fulfilling DSM IV criteria for dementia due to Parkinson?s disease).
•15. Patients with conditions affecting the peripheral or central sensory system
•unless related to Parkinson?s disease (such as mild sensory or pain syndromes
•limited to OFF periods) that could interfere with the evaluation of any such
•symptoms caused by the study drug.
•16. Patients with any condition that would make the patient, in the opinion of the
•Investigator, unsuitable for the study.

研究者

发起方

EISAI LTD UK

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