EUCTR2004-000557-35-GB进行中（未招募）1 期
A phase II, multi centre, pilot, randomised, ascending dose, double -blind, placebo controlled, dose titration study to determine the safety, maximum tolerated dose and preliminary evidence of efficacy of ralfinamide in the range of 80-320mg/day in patients with neuropathic pain.
ewron Pharmaceuticals SpA0 个研究点目标入组 144 人开始时间: 2005年2月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
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. Male or female patients aged 18-85 years, inclusive. If female, they must be post-menopausal for at least 12 months or surgically sterilized or have undergone hysterectomy.
- •2. Patients affected by current neuropathic pain (pain provoked by a lesion of the peripheral nervous system). The diagnosis should be made by a pain neurologist and based on history, clinical and/or laboratory findings in accordance with the taxonomy of the diagnostic criteria documented in the International Association for the Study of Pain (IASP) Classification of Chronic Pain. A neurological disease must be directly correlated with pain, including traumatic or ischemic nerve roots disease, nerve roots compression in spine disease, post herpetic neuropathy, diabetic neuropathy, nerve entrapment, traumatic mononeuropathy and polyneuropathy. Central neuropathic pain conditions must not be included. As a generic rule, nerve conduction studies are recommended to provide evidence of peripheral nerve injury. Each of these procedures must be clearly reported in the CRFs.
- •3. Patients must have a pain intensity of forty mm” (moderate) or greater on the Visual Analogue Scale (VAS) 100mm at screening and at baseline, where the onset of pain has occurred at least three months prior to the screening visit, as documented in the patient’s notes.
- •4. Patients with neuropathic pain in addition to spontaneous chronic pain may complain of stimulus evoked pain (allodynia, hyperalgesia) or shooting pains. The presence of such additional neuropathic symptoms will be recorded and the response to the treatment monitored.
- •5. Willing and able to understand and sign an approved 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •15. History of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment).
- •16. Any current axis I diagnosis including dementia, depression, psychosis, anxiety disorders, mental retardation etc.
- •18. History of allergic response to anticonvulsant drugs.
- •19. Hypersensitivity or contraindications to MAO-B inhibitors.
- •25. Treatment with SNRIs, MAO inhibitors (e.g. selegiline), meperidine derivatives in the 4 weeks prior to randomisation. Treatment with tri- or tetra-cyclic antidepressants will be permitted if taken at a stable dose for at least 4 weeks prior to study start (screening), providing that the dose will not be increased during the study. Treatment with opioids will be permitted if taken at a stable dose for at least 7 days prior to study start (screening), providing that the dose will not be increased during the study.
- •Patients with a history or concomitant diagnosis of seizure disorder, prior drug interactions, or past characterisation as slow metabolisers will be excluded.
- •27. Treatment with benzodiazepines (except if used as hypnotic), mexiletine, skeletal muscle relaxants, steroids (use for allergies is permitted), capsaicin, coumarin, anticoagulants and topical analgesics in the 2 weeks prior to randomisation. NSAIDs and minor analgesics (i.e. paracetamol) will be permitted if taken at a stable dose from at least 4 weeks prior to study start (screening), providing that the dose will not be changed during the study, and as rescue medication any time during the trial, based on the clinical judgement of the investigator. Tramadol is also allowed as rescue medication, provided it is not administered for more than two consecutive days during the same week. Treatment with antiepileptic drugs (AEDs) will be permitted if taken at a stable dose for at least 4 weeks prior to study start (screening), providing that the dose will not be increased during the study.
- •28. Treatment with neurostimulating devices such as spinal cord stimulation (SCS), transcutaneous electrical nerve stimulation (TENS) or peripheral nerve stimulation (PNS), acupuncture, homoeopathic remedies for pain or any kind of surgical treatment or blockade for the pain in the previous 4 weeks.
- •33. Patients who have a history of susceptibility to CNS adverse events, or who have experienced clinically important CNS adverse events on compounds mechanistically similar to ralfinamide e.g. carbamezapine, oxcarbazepine, lamotragine, phenytoin, topiramate, other anti-epileptics such as gabapentine, valproic acid, tiagabine, etc., should be excluded.
- •34. Patients with uncontrolled hypertension or those patients in whom hypertension has been recently diagnosed (less than 6 months) will be excluded from participation in the trial. Furthermore, patients with controlled hypertension who are included in the trial will be reminded to refrain from tyramine-rich food, and investigators will be asked to ensure that the blood pressure will be in the normal range in these patients prior to any dose increase.
- •35. Ophthalmologic history: Patients with the following conditions will be excluded: albino patients, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity i.e. 20/70, retinitis pigmentosa, retinal pigmentation due
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