NL-OMON52216尚未招募4 期
Treating Leg Symptoms in Women with X-linked Adrenoleukodystrophy: A Key to Improving Sleep and Gait Performance - Treating Leg Symptoms in Woman with X-ALD
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 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
- 年龄范围
- 18 至 64（—）
入选标准
- •PHASE 1 (PREVALENCE STUDY)
- •Inclusion Criteria:
- •- Women of any ethnic origin.
- •- Ability to provide verbal consent
- •- A willingness and ability to comply with study procedures.
- •- Age 18-75 years
- •- Metabolically or genetically confirmed diagnosis of ALD
- •PHASE 2 (CROSS-OVER STUDY)
- •Inclusion Criteria:
- •- Participation in Phase 1
- •- Ability to provide written informed consent
- •- Women with ALD who have Restless Leg Syndrome (IRLS > 15)
排除标准
- •1. Pregnant. Research staff perform pregnancy tests upon visit to center.
- •2. Participants with active or unstable major psychiatric disorder other than
- •ALD, who, in the investigators* judgement, require further treatment
- •3. Use of dopaminergic agonists or antagonists within the last 30 days
- •4. Alcohol use disorder within the last 30 days
- •5. History of being treated for restless legs syndrome, specifically with
- •dopamine agonist medications
- •6. Methamphetamine or benzodiazepine dependence in the last 30 days
- •7. Neurological disorder or cardiovascular disease raising safety concerns
- •about use of pramipexole and/or judged to interfere with ability to assess
- •efficacy of the treatment
- •8. Medical instability considered to interfere with study procedures
- •9. Renal disease judged to interfere with drug metabolism and excretion
- •10. Patients who are deemed a fall risk as determined by the PI
研究者
相似试验
进行中（未招募）
4 期
Treating Leg Symptoms in Women With X-linked AdrenoleukodystrophyRestless Legs SyndromeAdrenoleukodystrophyNCT05003648Massachusetts General Hospital24
尚未招募
不适用
Phenotyping X-linked adrenoleukodystrophy (X-ALD) in women: a cohort studySchilder's disease1002742410041543X-linked adrenoleukodystrophyNL-OMON31235Academisch Medisch Centrum40
招募中
不适用
Disease Progression in Women With X-linked AdrenoleukodystrophyX-linked AdrenoleukodystrophyNCT06178120Minoryx Therapeutics, S.L.40
招募中
不适用
Quality of Life in Women With X-linked AdrenoleukodystrophyX-linked AdrenoleukodystrophyNCT04675749Leipzig University Medical Center200
已完成
2 期
A Clinical Trial for AMN: Validation of Biomarkers of Oxidative Stress, Efficacy and Safety of a Mixture of AntioxidantsAdrenomyeloneuropathyNCT01495260Pujol, Aurora, M.D.13