Nucleo CMP and Neurorubine Versus Carbamazepine for Classical Trigeminal Neuralgia

NCT ID: NCT07304453

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-07
• Study Completion Date: 2024-09-30

Brief 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.

Detailed Description

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.

Conditions

Trigeminal Neuralgia; Neuropathic Pain

Keywords

Trigeminal Neuralgial; Nucleo CMP; Neurorubine; Carbamazepine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional Carbamazepine Therapy

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.

Group Type: ACTIVE_COMPARATOR

Conventional Carbamazepine Therapy

Intervention Type: DRUG

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 and Neurorubine Combination

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.

Group Type: EXPERIMENTAL

Nucleo CMP and Neurorubine Combination

Intervention Type: DRUG

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.

Interventions

Conventional Carbamazepine Therapy

Carbamazepine (Control): An anticonvulsant that acts primarily by blocking sodium channels to reduce nerve hyperexcitability. It provides symptomatic relief by suppressing pain transmission.

Intervention Type: DRUG

Nucleo CMP and Neurorubine Combination

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karbala University

OTHER

Sponsor Role: lead

Responsible Party

Salah M. Ibrahim

Chief oral surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oral Medicine Clinic, College of Dentistry, University of Kerbala

Karbala, Kerbala, Iraq

Countries

Iraq

Other Identifiers

Classical Trigeminal Neuralgia

Identifier Type: -

Identifier Source: org_study_id