Nucleo CMP and Neurorubine Versus Carbamazepine for Classical Trigeminal Neuralgia (NCT07304453) | Clinical Trial Compass
CompletedPhase 2
Nucleo CMP and Neurorubine Versus Carbamazepine for Classical Trigeminal Neuralgia
Iraq38 participantsStarted 2024-01-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Visual Analogue Scale (VAS) Score