Overview
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
Inclusion Criteria:
- 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.
- Patients who had previously failed (no response or no maintenance) guideline- specified first-line therapy for narcolepsy and had previously received at least one guideline-specified second-line treatment for narcolepsy type 1and failed (no response or no maintenance). Or patients who refused to drug treatment.
- Subjects with no significant laboratory abnormalities during screening.
- Patients and their legal guardians must comprehensively understand and be able to adhere to the study protocol requirements and willingly sign the informed consent form.
Exclusion Criteria:
- 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.
- Patients accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, etc.
