IRCT20210413050958N1尚未招募2 期
The effects of N-Acetyl-l-Leucine on the improvement of symptoms in patients with ataxia-telangiectasia: A double-blind crossover trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- no limit 至 no limit（—）
- 性别
- All
入选标准
- •Signed informed consent form by the subjects or their parents after explaining the study objectives by the research team
- •Patients with a definitive diagnosis of AT
- •Having clinical signs
- •Not addiction to Drugs and alcohol
- •If the patient is receiving concomitant speech therapy or physiotherapy, he/she has been on a stable dose/duration and type of therapy for at least 4 weeks before visit 1 and throughout the duration of the study
- •If the patient is taking any medication, he/she should maintain a constant dose/not change his/her treatment during the study period.
排除标准
- •Have not taken any forbidden drugs (including any variant of N-acetyl-DL-leucine, aminopyridines, Riluzole, gabapentin, Varenicline, Chlorzoxazone, sulfasalazine, Rosuvastatin at least 4 weeks before visit 1 and throughout the duration of the study
- •Asymptomatic patients
- •Patient who have clinical signs of A-T, but do not have a confirmed genetic test for A-T
- •Patients who have any of the following: Chronic diarrhea, Unexplained visual loss, Malignancies, Insulin-dependent diabetes mellitus, Known history of hypersensitivity to the N-Acetyl-Leucine (DL-, L-, D-) or derivatives
- •Having severe vision or hearing impairment that interferes with their ability to complete study assessments
- •Having a definite diagnosis of arthritis or other musculoskeletal disorders that affects patient's mobility and interferes with their ability to complete study assessments
研究者
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