Trigeminal Neuralgia
Conditions
Keywords
TGN, carbamazepine, oxcarbazepine
Brief summary
In this Study investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia , Carbamazepine vs Oxcarbazepine
Detailed description
In this open pilot open label randomized controlled trial, Investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia, Carbamazepine vs Oxcarbazepine , hypothesis would be that oxcarbazepine has equal or better outcomes comparatively with less side effects
Interventions
DRUGCarbamazepine
Carbamazepine is a conventional drug used to treat trigeminal neuralgia. It primarily works by blocking voltage-gated sodium channels in nerve cells, which prevents rapid and repetitive firing of action potentials and reduces abnormal electrical activity in the brain.
DRUGoxcarbazepine
Oxcarbazepine is comparatively new approved drug in the treatment of TGN. Oxcarbazepine is a prodrug that is rapidly converted to its active metabolite, (monohydroxy metabolite or MHD). This active form works by blocking voltage-sensitive sodium channels in the brain, which stabilizes over-excited nerve membranes and prevents the rapid spread of abnormal electrical activity
Sponsors
Abbasi Shaheed Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * Age 18-60 years * Either gender * TGN diagnosis for ≥2 weeks (according to ICHD-3 criteria¹)
Exclusion criteria
\[Expanded\]: * Other cranial neuralgias * Prior surgical treatment for TN * Hepatic/renal dysfunction * Epilepsy * Pregnant/lactating women * Drug allergy or intolerance * \[Expanded\] Uncontrolled hypertension * \[Expanded\] Psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief for TGN | Two months | Pain relief for Trigeminal neuralgia will be assessed define as complete resolution of symptoms (PAIN) , after prescribing both drugs to each individual group, Pain relief will be assessed using visual analogue scale (VAS SCORE) , which is designated by number 1 to 10, in which 1 means NO PAIN, and 10 means SEVERE PAIN. Annexure will be provided to each participant which includes study consent, demographic details, medical history in relevance with inclusion and exclusion criteria, side effects , LFTs values and printed Visual Analogue Scale on the very same document. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | Two months | Side effects of each drug will be compared including hepatotoxicity through liver functional tests, and other effects including nausea tolerability, dizziness etc. Annexure will be provided to each group participants ( same as mentioned in primary outcome section) ,which includes side effects column specifically Liver Functional Test results including both baselines values ( during the start of treatment ) and final results( at the end of treatment) and comparison will be made between the two drugs regarding side effects specifically hepatotoxicity. |
Countries
Pakistan
Outcome results
None listed