CompletedPhase 2

Nucleo CMP and Neurorubine Versus Carbamazepine for Classical Trigeminal Neuralgia

Iraq38 participantsStarted 2024-01-07

Plain-language summary

Trigeminal neuralgia is a severe facial pain condition that significantly impacts quality of life. While the standard medication, carbamazepine, provides relief, it is often associated with side effects and rapid pain recurrence upon discontinuation. This randomized clinical trial compares the efficacy and safety of conventional carbamazepine therapy against a novel combination therapy consisting of Nucleo CMP (cytidine monophosphate) and Neurorubine (Vitamin B complex). The study aims to evaluate pain reduction during active treatment and the sustainability of pain control after treatment cessation.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: .• Age between 18-80 years * Clinical diagnosis of classical trigeminal neuralgia according to International * Headache Society (IHS) diagnostic criteria * Pain duration of at least 3 months * Baseline Visual Analogue Scale (VAS) pain score greater than or equal to 4 * Ability to provide informed consent and comply with study procedures * No contraindications to study medications Exclusion Criteria: * Secondary trigeminal neuralgia due to underlying pathology * Atypical facial pain or other orofacial pain conditions * Significant cardiovascular, hepatic, or renal disease * Pregnancy or lactation * Current use of anticonvulsants or other neuropathic pain medications * History of allergic reactions to study medications * Cognitive impairment preventing reliable pain assessment * Concurrent participation in other clinical trials

What they're measuring

Change in Pain Intensity Visual Analogue Scale (VAS) Score

Timeframe: Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation)

Trial details

NCT IDNCT07304453

SponsorKarbala University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-14