Ofatumumab for drug-refractory Narcolepsy Type 1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests whether ofatumumab, given as a 20 mg dose, can improve symptoms in people with Narcolepsy Type 1 who have not responded to standard therapies. The trial will monitor sleepiness and cataplexy, as well as safety signals, before and after treatment. Participants will receive one dose, have a clinic visit about one month later, and keep a diary of symptoms. The study will collect CSF orexin-A data and HLA typing as part of eligibility and safety assessments. Results will help determine if ofatumumab is a viable option for drug-refractory NT1 and establish initial safety in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xijing Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Yonghong Liu, MD;PhD — The First Affiliated Hospital of Air Force Medical University
• Study coordinator: Yonghong Liu, MD;PhD
• Email: xjwxl2012@163.com
• Phone: 029-84771058

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Ofatumumab vs Ocrelizumab in Real-World MS Care

  This real-world study tests whether ofatumumab works differently from ocrelizumab for people with multiple sclerosis.

  Recruiting Novartis · East Hanover, New Jersey · NCT07779460

• Switching to Ofatumumab: IgG Levels in People with MS

  A real-life study tests whether stopping ocrelizumab and starting ofatumumab changes IgG levels in adults with multiple sclerosis who have been on ocrelizumab for at least 18 months.

  Recruiting University Hospital, Lille · Lille · NCT07625800

• VX-433 first‑in‑human safety and PK study in healthy volunteers

  This study tests the safety, how VX-433 behaves in the body, and possible drug interactions in healthy adults, to see if it’s suitable for people with narcolepsy type 1 in the future.

  Recruiting Phase 1 Vertex Pharmaceuticals Incorporated · Salt Lake City, Utah · NCT07584434

• Ofatumumab treatment and blood neurofilament levels in relapsing multiple sclerosis

  This observational study will try ofatumumab in adults with relapsing MS to see if it is safe and whether blood neurofilament light chain (sNfL) levels change.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT07353216

• Using eye movement biomarkers to track disease changes in active RRMS patients

  This study is testing if tracking eye movements can help doctors see how well a new treatment works for people with active Relapsing Remitting Multiple Sclerosis.

  Recruiting at 14 sites Phase 4 Novartis · Calgary, Alberta and 13 other locations · NCT06733922

• Observing the effects of Ofatumumab on Multiple Sclerosis in Greece

  This study is trying to see how well Ofatumumab works for adults with Relapsing Multiple Sclerosis in Greece over two years.

  Recruiting at 14 sites Novartis · Athens, Attica and 14 other locations · NCT06486779

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.