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RecruitingNCT07871006Updated Oct 13, 2026

Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1

A Phase 1/2 interventional study of ofatumumab 20mg in Narcolepsy Type 1 (NT1), sponsored by Xijing Hospital. Recruiting at 1 site in China. Open to participants aged 10 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Xijing Hospital · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2025, registered Sep 2026).
  • Started Oct 2025; still recruiting 1 year later.
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
10 Years to 60 Years
Sex
All
01

Study summary

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
02

Conditions studied

  • Narcolepsy Type 1 (NT1)
03

In context

Lead sponsor

Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.

Browse Xijing Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1

    Biological: ofatumumab 20mg

Interventions

  • Biologicalofatumumab 20mg

    all participants will be treated with one dose of subcutaneous injections of ofatumumab

06

What researchers measure

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 month

  2. cataplexy rate

    cataplexy rate was assessed through completion of an electronic patient-reported outcome diary.

    Time frame: one month

Secondary outcomes

  1. assessment of adverse events

    the incidence and severity of adverse events and serious adverse events were assessed.

    Time frame: one week

  2. assessment of adverse events

    the incidence and severity of adverse events and serious adverse events were assessed.

    Time frame: within one week

07

Study locations

1 of 1 sites recruiting
  • Xijing Hospital
    Xi'an, Shaanxi 710032, China
    Recruiting
08

References and documents

Publications

  • Donjacour CE, Lammers GJ. A remarkable effect of alemtuzumab in a patient suffering from narcolepsy with cataplexy. J Sleep Res. 2012 Aug;21(4):479-80. doi: 10.1111/j.1365-2869.2011.00985.x. Epub 2011 Dec 5. No abstract available. PubMed 22142323 ↗
  • Wasling P, Malmestrom C, Blennow K. CSF orexin-A levels after rituximab treatment in recent onset narcolepsy type 1. Neurol Neuroimmunol Neuroinflamm. 2019 Sep 4;6(6):e613. doi: 10.1212/NXI.0000000000000613. Print 2019 Nov. No abstract available. PubMed 31484686 ↗
  • Cross AH, Stark JL, Lauber J, Ramsbottom MJ, Lyons JA. Rituximab reduces B cells and T cells in cerebrospinal fluid of multiple sclerosis patients. J Neuroimmunol. 2006 Nov;180(1-2):63-70. doi: 10.1016/j.jneuroim.2006.06.029. Epub 2006 Aug 14. PubMed 16904756 ↗
  • Wang X, Zhang X, Yuan N, Liu Y. Ofatumumab treatment in new-onset narcolepsy type 1 following SARS-CoV-2 infection. Ann Clin Transl Neurol. 2025 Mar;12(3):666-669. doi: 10.1002/acn3.52284. Epub 2024 Dec 27. PubMed 39729629 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

Time frame: Sep 2025 to Dec 2027

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871006
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Oct 1, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Yonghong Liu, MD;PhD
Contact
xjwxl2012@163.com
029-84771058
Yonghong Liu, MD;PhD
principal investigator · The First Affiliated Hospital of Air Force Medicial University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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