Nucleo CMP and Neurorubine Versus Carbamazepine for Classical Trigeminal Neuralgia

Trigeminal neuralgia (TN) is a severe neuropathic pain disorder characterized by paroxysmal electric shock-like pain in the trigeminal nerve distribution. While anticonvulsants, particularly carbamazepine, are the first-line treatment, they often provide incomplete relief, are associated with dose-limiting side effects (sedation, dizziness), and may lead to tolerance over time. This study investigates a novel therapeutic approach targeting nerve regeneration rather than solely symptom suppression.

This randomized, assessor-blinded, parallel-group, active-controlled clinical trial evaluates the efficacy, safety, and long-term sustainability of a combination therapy consisting of Nucleo CMP (cytidine monophosphate) and Neurorubine (Vitamin B complex: B1, B6, B12) compared to conventional carbamazepine therapy.

The study enrolled 38 patients diagnosed with classical trigeminal neuralgia according to International Headache Society criteria. Participants were randomized to one of two arms:

Control Group: Received Carbamazepine initiated at 100mg twice daily, titrated based on response and tolerability up to 400mg twice daily.

Intervention Group: Received a combination protocol. For weeks 1-6, participants took two capsules of Nucleo CMP and two tablets of Neurorubine daily. For weeks 7-9, participants entered a maintenance phase taking one tablet of Neurorubine daily.

The primary objective is to assess pain reduction using the Visual Analogue Scale (VAS). Secondary objectives include the frequency of pain attacks per day, safety/tolerability profiles, and the sustainability of pain control following the cessation of active treatment. Assessments were conducted at baseline, 3 weeks, 6 weeks, and 3 weeks following treatment cessation. The study hypothesizes that the neuroprotective and neuroregenerative properties of the combination therapy will provide superior sustained pain control compared to the symptomatic relief provided by carbamazepine.

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