Neuromyelitis Optica Spectrum Disorders
Conditions
Interventions
Experimental Group:Oxcarbazepine 300mg twice daily for 3 days ? 450mg twice daily for 4 days.
Control group:The placebo has no effective drug components. Placebo 300mg twice a day for 3 days ? 450mg twice a day for 4 days
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Male or female, aged 18–75 years; (2) Diagnosed with NMOSD according to Wingerchuk (2015) diagnostic criteria; (3) Presence of painful spasms. Definition: Painful Tonic Spasms (PTS): Paroxysmal, recurrent muscle spasms in one or more limbs and/or trunk lasting seconds to minutes, accompanied by severe pain and muscle rigidity. (4) Daily pain score >=4 (NRS 0-10) during the baseline period (at least 3 days prior to trial initiation) following discontinuation of analgesics; (5) No use of analgesics such as oxcarbazepine/pregabalin/gabapentin/ duloxetine or muscle relaxants such as baclofen/tizanidine, or discontinuation for>=1 week; (6) Patients in the acute phase have transitioned from intravenous to oral corticosteroids, and those undergoing plasma exchange/immunoadsorption have completed their final exchange/adsorption treatment; (7) The patient possesses sufficient cognitive function and language ability to complete telephone communication and research questionnaires. (8) Informed consent has been obtained.
Exclusion criteria
Exclusion criteria: (1) Known allergy or severe adverse reaction to oxcarbazepine or carbamazepine. (2) Coexisting pain conditions of comparable severity to neuropathic pain. (3) Concurrent severe local or systemic diseases (e.g., cardiac conduction block, severe hepatic or renal dysfunction [aspartate aminotransferase and alanine aminotransferase concentrations exceeding 120% of the upper limit of normal, serum creatinine concentration exceeding 150% of the upper limit of normal], hyponatremia [serum sodium level <135 mmol/L]). (4) Concurrent epilepsy or suspected epilepsy. (5) Any life-threatening laboratory abnormalities or significant clinical symptoms (including psychiatric disorders). (6) Pregnancy or intention to become pregnant during the study, or current breastfeeding. (7) Concurrent use of antidepressants, other anticonvulsants, neuromuscular blockers, non-discontinued opioids, benzodiazepines (e.g., clonazepam), or barbiturates (e.g., phenytoin). (8) Use of IL-6 receptor blockers. (9) Presence of hereditary neuropathy or neuropathy caused by other etiologies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Penn Spasm Frequency Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average Daily Pain Intensity;Overall Improvement.;Brief Pain Inventory;Self-rating Anxiety Scale ;Intensity of Nighttime Pain.; | — |
Countries
China
Contacts
Public ContactDecai Tian
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed