Nucleo CMP and Neurorubine Versus Carbamazepine for Classical Trigeminal Neuralgia

NCT07304453 | Completed Phase 2 DMC

• 1 other identifier: Classical Trigeminal Neuralgia
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Trigeminal Neuralgia

Keywords

Trigeminal Neuralgial; Nucleo CMP; Neurorubine; Carbamazepine

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (1)

• Frequency of Pain Attacks

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

Study Arms (2)

Conventional Carbamazepine Therapy

ACTIVE COMPARATOR

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

Nucleo CMP and Neurorubine Combination

EXPERIMENTAL

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

Interventions

Nucleo CMP and Neurorubine Combination 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.

Nucleo CMP and Neurorubine Combination

Conventional Carbamazepine Therapy DRUG

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

Conventional Carbamazepine Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karbala University: lead

Study Sites (1)

Oral Medicine Clinic, College of Dentistry, University of Kerbala

Karbala, Kerbala, Iraq

Location

MeSH Terms

Conditions

Trigeminal Neuralgia; Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief oral surgery department

Model Details: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 26, 2025
• Study Start: January 7, 2024
• Primary Completion: July 14, 2024
• Study Completion: September 30, 2024
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

IR (1)