Hydralazine and valproate in recent onset narcolepsy

Phase 1

• Conditions: arcolepsy type 1; MedDRA version: 20.0Level: PTClassification code 10028713Term: NarcolepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-003671-19-NL
• Lead Sponsor: Stichting Epilepsie Instellingen Nederland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-13
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified