ISRCTN17106427进行中（未招募）2 期
Randomised double blind placebo controlled trial of L-serine in Hereditary Sensory Neuropathy type 1
niversity College London0 个研究点目标入组 50 人开始时间: 2023年3月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- 性别
- All
入选标准
- •1. Participants aged =18 years with genetically proven HSN1 due to SPTLC1/2 mutations.
- •2. Participants must be able to undergo an MRI scan without sedation.
- •3. Participants must be able to complete the Charcot Marie Tooth Examination Score (CMTES)
- •4. Participants must have a CMTES =26
- •5. Female participants of childbearing potential who are sexually active must agree to use a highly effective method of contraception from the time consent is signed until six days after treatment discontinuation (this is due to a lack of safety data on use of L-serine in pregnant and breastfeeding women; and to allow for medication wash out post treatment discontinuation). Highly effective methods of contraception include:
- •5.1. Combine hormonal contraception associated with inhibition of ovulation
- •5.2. Progesterone only hormonal contraception associated with inhibition of ovulation
- •5.3. Intrauterine device
- •5.4. Intrauterine hormone-releasing system
- •5.5. Bilateral tubal occlusion
- •5.6. Vasectomised partner (when this is the sole partner of the patient)
- •5.7. Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period associated with the study treatments, and the reliability of sexual abstinence is in line with the usual lifestyle of the subject)
- •6. Participants must be willing and able to provide written informed consent.
排除标准
- •1. Participants have undergone foot surgery in the 6 months prior to trial enrolment or are due to undergo foot surgery during the trial.
- •2. Participants have a history of nephrolithiasis.
- •3. Participants have another medical condition or metal implant which precludes them from having an MRI scan
- •4. Participants have another medical condition which precludes them from completing CMESv2.
- •5. Participants with known diagnosis of another neuromuscular disease.
- •6. Participants with type 1 and 2 diabetes.
- •7. Females who are pregnant or are planning pregnancy or breastfeeding.
- •8. Patient taking regular L-serine supplementation within 6 months of study commencement.
研究者
相似试验
已完成
不适用
Randomised double blind placebo controlled trial of calcium supplements in teenage pregnancySigns and Symptoms: Burning Mouth Syndrome (BMS).Signs and SymptomsBurning Mouth Syndrome (BMS).ISRCTN25268811Record Provided by the NHSTCT Register - 2006 Update - Department of Health15
已完成
4 期
Randomised double blind placebo controlled trial on the effect of intraperitoneal ropivacaine on postoperative pain and recovery after diagnostic laparoscopy and hysteroscopy.Post operative pain following day case gynaecological diagnostic laparoscopy and hysteroscopy.Postoperative nausea and vomiting following day case gynaecological diagnostic laparoscopy and hysteroscopyPostoperative recovery following day case gynaecological diagnostic laparoscopy and hysterocopy.Anaesthesiology - AnaestheticsACTRN12609000128291Dr Natasha Frawley60
已完成
不适用
Randomised double blind placebo controlled trial of antimicrobial treatment in pregnant women at risk of preterm labourPregnancy and Childbirth: Preterm labourPregnancy and ChildbirthISRCTN43735180Department of Health (UK)75
已完成
不适用
Randomised double blind placebo controlled trial of the efficacy of gabapentin in improving analgesia in patients undergoing hysterectomy receiving patients controlled analgesiaSigns and Symptoms: PainSigns and SymptomsPainISRCTN54176811Department of Health
尚未招募
2 期
Randomized double blind controlled trial to assess the safety and efficacy of three investigational herbal preparations (nut meg based preparation, sudarshana churna, coriandum based preparation) for the treatment of patients with COVID-19COVID 19SLCTR/2021/008niversity of Peradeniya