Narcolepsy type 1 MedDRA version: 20.0 Level: PT Classification code 10028713 Term: Narcolepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Hydralazine HCl CF
Pharmaceutical Form: Tablet
INN or Proposed INN: HYDRALAZINE HYDROCHLORIDE
CAS Number: 304-20-1
Other descriptive name: HYDRALAZINE HYDROCHLORIDE
Trade Name: Natriumval
Sponsors
Stichting Epilepsie Instellingen Nederland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Fulfilling the ICSD3 criteria for NT1, including a hypocretin-1 level in the CSF 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - Weekly cataplexy rate (complete/partial) as assessed in a diary before and after treatment.;Timepoint(s) of evaluation of this end point: Before and after administration of study medication.;Main Objective: To assess whether hydralazine in combination with valproate is effective in treating the symptoms of narcolepsy.;Secondary Objective: To assess the safety of treating NT1 patients with hydralazine in combination with valproate. To assess whether the efficacy of hydralazine in combination with valproate is reflected in an increased concentration of hypocretin-1 in the CSF. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS).- Improvement of fragmentation index, sleep efficiency and REM latency on the polysomnography (PSG). - Improvement of mean sleep latency (> 8 min) and/or sleep-onset REM periods (SOREMPs; 4 points decreased and/or weekly cataplexy rate > 75% decreased).;Timepoint(s) of evaluation of this end point: Before and after administration of study medication. | — |
Countries
Netherlands, Switzerland
Contacts
Public ContactSecretariaat Slaap-Waakcentrum
Stichting Epilepsie Instellingen Nederland
Outcome results
None listed