EUCTR2007-001109-26-GB进行中（未招募）1 期
A phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
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. Signed and dated written informed consent obtained from the patient and/or the patient’s legally acceptable representative, if applicable, in accordance with the local regulations
- •2. Diagnosed with bilateral idiopathic PD
- •3. Diagnosis of PD > five years, using diagnostic criteria from core assessment program for surgical interventional therapies CAPSIT (1999)
- •4. Males/females between 48 and 65 years
- •5. Women must be surgically sterile or postmenopausal, with last menstrual period being over two years ago
- •6. Male patients must be surgically sterile or agree to use two forms of contraception, including one barrier method for at least three months following ProSavin administration if their partner is of child-bearing capacity
- •7. Response to L-DOPA where an increase in dose is unacceptable to the patient due to potentiating the fluctuations in motor functions
- •8. Hoehn and Yahr stage 3 and 4
- •9. UPDRS (Part III) of between 20 and 60 in the OFF” state
- •10. Stable dosing of PD medication, including L-DOPA, and any treatments (if required) for sleep apnea syndrome for four weeks prior to surgery
- •11. Positive response to dopaminergic therapy as defined by a 50% improvement in UPDRS (Part III) between the OFF” and ON” states
- •12. Presence of motor fluctuations
- •13. Willing to have current treatment withdrawn for up to 24 hours prior to surgery therefore being in an OFF” state for surgery
- •14. Willing to have their L-DOPA dosage reduced/withdrawn at the discretion of the principle investigator (PI) at regular intervals following surgery to allow assessment of ProSavin in the absence of concomitant anti-parkinsonian medication
- •15. Affiliated with the French social security health care system (French patients only)
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Major surgery within the 28 days prior to enrolment
- •2. Severe disabling dyskinesias = 51% of the day as defined by the UPDRS (Part IV)
- •3. History of psychosis or current treatment with dopamine blocking agents of any kind
- •4. Severe depression as defined by a BDI score of >16. Any treatment for depression should be limited to serotonergic therapies and those that do not target the dopaminergic pathways
- •5. Prior treatment with tolcapone, within the six months prior to enrolment into the study, due to its ability to modify dopaminergic pathways within the brain
- •6. History of epilepsy or any other co-morbid condition that the Investigator believes presents an unacceptable health risk to the patient in conjunction with the procedures in this protocol
- •7. Life-threatening illness unrelated to PD
- •8. History of stereotactic or other surgery for the treatment of PD
- •9. Premenopausal women
- •10. Alcohol or other substance abuse
- •11. Clinically significant laboratory test abnormalities, including full blood count, chemistry panel, liver function tests, electrocardiogram (ECG), Chest X rays
- •12. Any contraindication for undergoing an MRI scan of the head
- •13. Intercurrent illness or infection 28 days prior to enrolment
- •14. Abnormal MRI findings such as mega cisterna, septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumours, vascular diseases, trauma or areteriovenous malformations (AVM)
- •15. Prior regular exposure to neuroleptic agents
- •16. History of treatment with any agent that may induce PD or PD symptoms within the last three months prior to enrolment
- •17. Contraindications to use of anaesthesia
- •18. Treated with dopaminergic antagonists six months prior to screening
- •19. Concurrent anti-retroviral therapy that would inactivate the investigational agent
- •20. History of any investigational agent within 28 days prior to ProSavin administration
- •21. Participation in a prior gene transfer therapy study
- •22. Enrolment in any other clinical study, for any condition, including those relating to PD, throughout the duration of the ProSavin study
- •23. Current or anticipated treatment with anticoagulant therapy or the use of anticoagulation therapy within the four weeks prior to surgery
- •24. Diagnosis of multiple system atrophy (MSA) following assessment of the autonomic nervous system function (e.g. blood pressure, difficulty in urinating and sexual activity) and MRI during the screening process
- •25. Administration of subcutaneous rescue remedy apomorphine
- •26. Patients unable to adhere to their prescribed PD medication regime
研究者
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