A Phase 2 interventional study of Conventional Carbamazepine Therapy and Nucleo CMP and Neurorubine Combination in Trigeminal Neuralgia and Neuropathic Pain, sponsored by Karbala University. Completed at 1 site in Iraq. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Karbala University · Phase 2, Interventional, and Treatment
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.
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.
135 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's enrollment of 38 is close to the median of 40 across 92 interventional studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →Karbala University is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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.• Age between 18-80 years
Exclusion Criteria:
Participants received conventional carbamazepine tablets administered orally with meals. Treatment was initiated at 100 mg twice daily, with dose titration based on clinical response and tolerability up to a maximum of 400 mg twice daily.
Drug: Conventional Carbamazepine Therapy
participants received a combination regimen administered orally with meals. During Weeks 1-6, patients took two capsules of Nucleo CMP daily plus two tablets of Neurorubine daily. During Weeks 7-9 (maintenance phase), patients took one tablet of Neurorubine daily.
Drug: Nucleo CMP and Neurorubine Combination
Carbamazepine (Control): An anticonvulsant that acts primarily by blocking sodium channels to reduce nerve hyperexcitability. It provides symptomatic relief by suppressing pain transmission.
Nucleo CMP + Neurorubine (Experimental): A combination of nucleotides (cytidine monophosphate) and neurotropic B-vitamins (B1, B6, B12). This intervention aims to be neuroregenerative, promoting myelin formation and axonal repair rather than just suppressing pain signals.
Change in Pain Intensity Visual Analogue Scale (VAS) Score
Pain intensity was assessed using a standardized 10-point Visual Analogue Scale (VAS). Patients indicated their pain level on a continuous line anchored by 0 and 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores indicate greater pain intensity. Assessments were recorded at Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation).
Time frame: Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation)
Frequency of Pain Attacks
The average number of paroxysmal pain attacks occurring per day, recorded by patients in daily diaries. Higher numbers indicate higher disease burden.
Time frame: Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation)
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Karbala University