Tolerability and analgesic efficacy of Loxapine in patients with refractory, chemotherapy-induced neuropathic pain

Private Universität Witten/Herdecke gGmbH0 个研究点目标入组 12 人开始时间: 2015年3月11日最近更新: 2018年1月8日

试验速览

暂无简介。

•- Chemotherapy induced neuropathic pain of at least 3 months refractory to at least one analgesic compound
•- Neuropathic pain = 4 (11-point numeric pain rating scale) at screening visit (including mixed pain)
•- Age: =18 years
•- Body weight between 50 to 150 kg
•- Given 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 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•- Participation in other interventional studies (current or within the last 3 months)
•- Parkinson’s disease, movement disorders (extrapyramidal signs and symptoms) associated with antipsychotics, Neuroleptic malignant syndrome, other syndromes associated with antipsychotics
•- Severe hypotension with a syncope in history, glaucoma, urinary retention, epilepsy or other seizure disorders in history, severe dementia, dementia related psychosis in history, breast cancer in medical history, malignancies with a life expectancy of less than 6 months, other severe and life-threatening diseases
•- Known drug or alcohol abuse
•- Concomitant intake of antipsychotics, dopamine agonists (levodopa, bromocriptine, lisuride, pergolide, ropinirole, cabergoline, pramipexole, apomorphine), alpha-receptor blocking compounds or compounds with a known potential for QT interval prolongation
•- Pregnancy or lactation period
•- Pre- or perimenopausal females with ineffective contraception
•- Close affiliation with the investigational site

发起方

Private Universität Witten/Herdecke gGmbH