NL-OMON54746招募中2 期
Efficacy and safety of hydralazine in combination with valproate to treat hypocretin deficiency in recent onset narcolepsy: a pilot study - Hydralazine and valproate in recent onset narcolepsy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 4
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
- 16 至 64（—）
入选标准
- •- Fulfilling the ICSD3 criteria for NT1, including a hypocretin-1 level in the
- •CSF < 110 pg/ml (sleep deprivation should be excluded).
- •- Recent symptoms of narcolepsy (<5 years).
- •- Baseline Epworth Sleepiness Scale (ESS) >= 14.
- •- > 7 cataplexy attacks per week (complete or partial) at baseline as assessed
- •by a cataplexy diary.
- •- Regular schedule for nocturnal sleep and time in bed > 6 hrs as assessed by
- •actigraphy and sleep diary.
- •- BMI 18-35 kg/m2.
- •- For females: use of a medically acceptable method of contraception for at
- •least 2 months prior to the first dose of study drug and consent to continue
- •the practice throughout the entire study and for 30 days after the study is
- •completed. No pregnancy planned for one year after participation.
- •- Willing and able to comply with the study design schedule and all other
- •requirements.
- •- Willing and able to provide written informed consent.
排除标准
- •- Use of any psychotropic medication during the last 6 weeks before inclusion,
- •with exception for stimulants: use of stimulants during the last week before
- •- Pharmacological treatment for hypertension or epilepsy.
- •- Female subjects who are pregnant (as assessed by pregnancy test at baseline),
- •nursing or lactating.
- •- Occupation requiring nighttime shift work or variable shift work.
- •- Any other severe clinically relevant medical, behavioural, or psychiatric
- •disorder, particularly past or present condition of heart failure from aortic
- •stenosis and postural hypotension as diagnosed by a physician.
- •- Any contraindication against using either hydralazine or valproate.
- •- Significant laboratory abnormality as assessed during baseline.
研究者
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