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

Stichting Epilepsie Instellingen Nederland0 个研究点目标入组 8 人开始时间: 2020年1月13日最近更新: 2023年10月3日

试验速览

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•- Fulfilling the ICSD3 criteria for NT1, including a hypocretin-1 level in the CSF < 110 pg/ml.
•- 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.
•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 8
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Use of any psychotropic medication during the last 6 weeks before inclusion, with exception for stimulants: use of stimulants during the last week before inclusion.
•- 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.

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