Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1
ConditionNarcolepsy Type 1 (NT1)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age10-60
SponsorXijing Hospital
About this trial
The goal of this clinical trial is to learn if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1. It will also learn about the safety of ofatumumab. The main questions it aims to answer are:
* Does ofatumumab could improve persistent or chronic NT1 who had insufficient responses to multiple prior treatment regimens or declined conventional medications? * The safety -What medical problems do participants have when taking ofatumumab? Researchers will compare Epworth Sleepiness Scale and cataplexy frequency before and after ofatumumab treatment to see if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1.
Participants will:
* Take one dose of ofatumumab and monitoring one day for the injection-related reactions * Visit the clinic at one month after ofatumumab for checkups and tests * Keep a diary of their symptoms
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients who were clinically diagnosed with narcolepsy type 1
aged10-60 years, male or female.
A lumbar puncture was performed to evaluate the CSF orexin-A level.
HLA typing was performed.
Disqualifiers
Patients allergic to ofatumumab, or had failed to respond to previous treatment with ofatumumab.
Patients were excluded if they had a previous immune disease, or patients diagnosed with various secondary and hereditary auto-immune disorders, contraindications to lumbar puncture, conditions or medication with known substantial impact on the immune system, with impact on the result of lumbar puncture.
Patients with uncontrollable primary diseases of important organs, such as liver failure, heart failure, renal failure and other diseases.
Patients who are positive for HIV antibodies or syphilis antibodies.
Trial design
Design model
Single group
Treatments tested in this trial
ofatumumab 20mg
Biological/Vaccineall participants will be treated with one dose of subcutaneous injections of ofatumumab
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the Epworth Sleepiness Scale （ESS ：0-24）
The ESS scale contain eight items. Each item is rated from 0 to 3, with 0 meaning you would never doze or fall asleep in a given situation, and 3 meaning there is a very high chance that you would doze or fall asleep in that situation. The ESS score was assessed at baseline and after the first dose, higher scores mean a worse outcome.
Time frame
one month2
cataplexy rate
cataplexy rate was assessed through completion of an electronic patient-reported outcome diary.
Time frame
one monthSecondary outcomes
1
assessment of adverse events
the incidence and severity of adverse events and serious adverse events were assessed.
Time frame
one week2
assessment of adverse events
the incidence and severity of adverse events and serious adverse events were assessed.
Time frame
within one weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov