Trigeminal NeuralgiaPhase 2NCT07304453
Nucleo CMP and Neurorubine Versus Carbamazepine for Classical Trigeminal Neuralgia
A Phase 2 study testing Conventional Carbamazepine Therapy and Nucleo CMP and Neurorubine Combination in people with Trigeminal Neuralgia and Neuropathic Pain, run by Karbala University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia, Neuropathic Pain
- What is being tested?
- Conventional Carbamazepine Therapy and Nucleo CMP and Neurorubine Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIraq
- Study dates
- 7 Jan 2024to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .• 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Oral Medicine Clinic, College of Dentistry, University of Kerbala
Karbala, Kerbala
About this study
Official title: Combination Therapy With Nucleo CMP and Neurorubine Provides Sustained Long-term Pain Control Compared to Carbamazepine in Classical Trigeminal Neuralgia: A Randomized Clinical Trial
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.
Read the 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
- Being tested
- Conventional Carbamazepine Therapy, Nucleo CMP and Neurorubine Combination
- Keywords
- Trigeminal Neuralgial, Nucleo CMP, Neurorubine, Carbamazepine
- Medical subject headings
- Trigeminal Neuralgia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Carbamazepine TherapyDrug
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 CombinationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nucleo CMP and Neurorubine Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation)
Secondary outcomes (1)
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.
Measured: Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start7 Jan 2024
- Primary completion14 Jul 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karbala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah M. Ibrahim, Kufa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304453
- Sponsor's protocol ID
- Classical Trigeminal Neuralgia
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Nucleo CMP and Neurorubine Provides Sustained Long-term Pain Control Compared to Carbamazepine in Classical Trigeminal Neuralgia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07304453
- Acronym / sponsor ID
- Classical Trigeminal Neuralgia
- Conditions
- Trigeminal Neuralgia, Neuropathic Pain
- Keywords
- Trigeminal Neuralgial, Nucleo CMP, Neurorubine, Carbamazepine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Karbala UniversityUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment
| Arm | Type | Receives |
|---|---|---|
| Conventional Carbamazepine Therapy | Active comparator | Drug: Conventional Carbamazepine TherapyParticipants 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. |
| Nucleo CMP and Neurorubine Combination | Experimental | Drug: Nucleo CMP and Neurorubine Combinationparticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- .• 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Carbamazepine TherapyCarbamazepine (Control): An anticonvulsant that acts primarily by blocking sodium channels to reduce nerve hyperexcitability. It provides symptomatic relief by suppressing pain transmission. | Drug | Conventional Carbamazepine Therapy |
| Nucleo CMP and Neurorubine CombinationNucleo 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. | Drug | Nucleo CMP and Neurorubine Combination |
Primary outcome
Change in Pain Intensity Visual Analogue Scale (VAS) Score
Time frame: Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation)
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).
1 secondary outcome
Frequency of Pain Attacks
Time frame: Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional Carbamazepine Therapy and Nucleo CMP and Neurorubine Combination in people with Trigeminal Neuralgia and Neuropathic Pain, run by Karbala University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Visual Analogue Scale (VAS) Score (time frame: Baseline, Week 3, Week 6, and Week 9 (3 weeks post-treatment cessation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.