EUCTR2020-002438-34-DK进行中（未招募）1 期
Fampridine for treatment of residual neurological deficits in patients treated with immunoglobulins for chronic inflammatory demyelinating polyneuropathy
Department of Neurology, Odense University Hospital0 个研究点目标入组 40 人开始时间: 2020年6月11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
- 40
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.Age = 18 and = 80 years.
- •2.Diagnosis with CIDP or MGUS-associated demyelinating neuropathy fulfilling the criteria of European Federation of Neurological Societies.
- •3.Stable, ongoing treatment with SCIG
- •4.Written informed consent.
- •5.ONLS = 1 for the lower extremities and/or ONLS = 2 for the upper extremities
- •6.Average SSST for both legs > 8.6 s and/or average 9HPT for both hands > 23.0 s.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Diagnosis of claudicatio intermittens or obvious vascular disease manifestation in the lower extremities at the discretion of the physician.
- •2.Clinically significant back disease or clinical sign of spinal root affection or spinal stenosis at the discretion of the physician.
- •3.Clinically significant systemic disease at the discretion of the physician.
- •4.Patient with other diseases that are expected to affect the ability to walk or the use of the arms at the discretion of the physician.
- •5.Patients who cannot cooperate or are unable to complete the project and patients who do not speak Danish or English.
- •6.Impaired kidney function (eGFR < 80 ml/min.)
- •7.Epilepsy or medical history of seizures.
- •8.Risk factors for seizures (reduced seizure threshold) either due to drug treatment (e.g. antipsychotics, antidepressants, anti-malaria drugs, tramadol, theophylline, sedating anti-histaminergic drugs) or other diseases (e.g. previous significant head trauma or diabetes with frequent episodes of significant hypoglycemia) as evaluated by an experienced neurologist.
- •9.Risk of important drug interactions (drugs inhibiting OCT2, e.g. cimetidine).
- •10.Pregnancy or lactation.
- •11.Women of child-bearing potential, unless they use an acceptable effective contraception measure during the study and at least 2 weeks after or their male partner, is vasectomized and their sole partner. Acceptable effective contraception is defined in the Clinical Trials Facilitation Group (CTFG) http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) and include intrauterine device or hormone-releasing system or hormonal contraception or total abstinence when this reflects their usual lifestyle or female sterilization (bilateral oophorectomy or total hysterectomy at least 6 weeks before). They should also have a negative pregnancy test.
- •12.Known allergy to fampridine or excipients.
- •13.Concurrent treatment with Fampyra or other medicinal products containing fampridine (4-aminopyridine)
- •14.Patients inappropriate for placebo.
- •15.Planned surgery.
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