EUCTR2015-001523-24-FR进行中（未招募）1 期
Evaluation of the analgesic effects of prolonged-release oxycodone and of L-Dopa, versus placebo, on central neuropathic pain in Parkinson's disease : OXYDOPA trial - OXYDOPA
HToulouse0 个研究点目标入组 75 人开始时间: 2016年4月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
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
- •-Patients with Parkinson’s disease according to the UKPDSBB criteria
- •-Patients aged 40 to 75 years (male or female)
- •-Patients suffering from chronic pain (lasting for more than 3 months)
- •-Patients suffering from central neuropathic pain caused by PD, as identified with a two-part clinical questionnaire:
- •The first part assesses the causality of the link between PD and pain i.e. pain is considered to be related to PD if the patient reports at least three of the following five features:
- •- Pain is chronologically related to PD (occurring at the onset of PD or influenced by motor condition)
- •- Pain located in the half of the body most severely affected by PD (topographical relationship to PD)
- •- Pain is influenced by dopaminergic drugs
- •- Pain is not related to any other evident etiology (rheumatic, traumatic or orthopedic disorders)
- •- The patient identifies a link between pain and disease
- •The second part identifies central neuropathic pain i.e. pain is considered to be central neuropathic pain if it fulfills the two following criteria:
- •- There is no radicular systematization
- •- Symptoms are defined as having the clinical characteristics of neuropathic pain with the DN4 interview questionnaire
- •-Patients with a PD-related central neuropathic pain intensity of at least 3 points on the VAS (average intensity over the last month),
- •-Patients with both types of pain (neuropathic and nociceptive) will be included if the neuropathic pain predominates (higher intensity)
- •-Patients treated with a stable regimen of dopaminergic drugs (levodopa and/or dopamine agonists) for at least 4 weeks before the study dan thoughout the study
- •-Patients with a stable step 1 analgesic (NSAIDS, acetaminophen) or coanalgesic (antidepressants, antiepileptic) treatment for at least 4 weeks before the study and throughout the study
- •-Patients with health insurance
- •-Patients who have signed a written informed consent form
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •General exclusion criteria:
- •-Patients suffering from another parkinsonian syndrome (multiple system atrophy, progressive supranuclear palsy etc.)
- •-De Novo patients (patients never before treated with dopaminergic drugs)
- •-Patients with intercurrent acute pain
- •-Patients suffering from a chronic disease causing pain (rheumatoid arthritis, ankylosing spondylitis, diabetic neuropathy, cancer etc.)Patients treated with neuroleptics (clozapine, risperidone etc.)
- •-Patients treated by deep brain stimulation
- •-Patients with clinically detectable behavioural disorders (impulse control disorder, hallucinations, delirium) and addiction
- •-Patients with disabling dyskinesias (items MDS-UPDRS 4.1 and 4.2 >1)
- •-Patients with painful restless legs syndrome
- •-Patients with cognitive impairment (MMS < 25) or unable to complete the various scales used in the study
- •-Patients under juridical protection
- •-Patients refusing to participate
- •-Women pregnant, nursing or of childbearing age without effective contraception.
- •Exclusion criteria relating to treatments:
- •-Hypersensitivity to oxycodone, levodopa, benserazide or a combination of these drugs
- •-Patients treated with opioid drugs (step 2 and 3)
- •-Patients treated with non-selective monoamine oxidase inhibitors (MAOI)
- •-Patients with severe hepatocellular insufficiency
- •-Patients with uncontrolled cardiovascular and pulmonary diseases
- •-Persistent constipation that has already resulted in a subocclusive state
- •-Patients treated with antiemetic neuroleptics
- •-Patients with angle-closure glaucoma
- •Exclusion criteria relating to MRI:
- •-Patients with claustrophobia
- •-Patients with a hearing aid, cardiac prosthesis, pacemaker, surgical clip
- •-Patients refusing to be informed of abnormalities are detected on MRI
研究者
相似试验
已完成
不适用
Transverse muscle block effect in analgesia after cesarean sectioacute pain after cesarean section.Acute painIRCT2016120431225N1Vice Chancellor for research of Iran University of Medical Sciences76
进行中（未招募）
不适用
Study of the analgesic effects of repeated doses of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain. A multinational, multicenter, randomized, double blind, parallel groups, placebo-controlled study.Central neuropathic pain due to spinal cord injury, based on clinical history, clinical examination and appropriate assessment of patient’s signs and symptoms, according to the International Association for the Study of Pain (IASP) definitionMedDRA version: 9.1Level: LLTClassification code 10064012Term: Central pain syndromeEUCTR2007-003230-42-HUPIERRE FABRE MEDICAMENT124
进行中（未招募）
1 期
Study of the analgesic effects of repeated doses of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain. A multinational, multicenter, randomized, double blind, parallel groups, placebo-controlled study.EUCTR2007-003230-42-FRPIERRE FABRE MEDICAMENT124
进行中（未招募）
不适用
Study of the analgesic effects of repeated doses of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain. A multinational, multicenter, randomized, double blind, parallel groups, placebo-controlled study.EUCTR2007-003230-42-NLPIERRE FABRE MEDICAMENT124
进行中（未招募）
不适用
Study of the analgesic effects of repeated doses of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain. A multinational, multicenter, randomized, double blind, parallel groups, placebo-controlled study.Central neuropathic pain due to spinal cord injury, based on clinical history, clinical examination and appropriate assessment of patient’s signs and symptoms, according to the International Association for the Study of Pain (IASP) definitionMedDRA version: 9.1Level: LLTClassification code 10064012Term: Central pain syndromeEUCTR2007-003230-42-FIPIERRE FABRE MEDICAMENT124