Using Pregabalin with Carbamazepine for Trigeminal Neuralgia Pain Relief
Evaluation of Efficacy of Pregabalin as an Add on Therapy With Carbamazepine in Patients of Trigeminal Neuralgia"- A Randomized Control Trial
This study is testing if adding Pregabalin to Carbamazepine can help people with severe facial pain from Trigeminal Neuralgia feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak, Haryana) |
| Trial ID | NCT06357260 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of Pregabalin as an add-on therapy to Carbamazepine in patients suffering from Trigeminal Neuralgia, a condition characterized by severe facial pain. The study will recruit 50 patients diagnosed with classical Trigeminal Neuralgia, who will be randomly assigned to either a test group receiving both Pregabalin and Carbamazepine or a control group receiving only Carbamazepine. The primary objective is to compare changes in pain intensity between the two groups, while secondary objectives include assessing the mean dose of Carbamazepine, quality of life, patient satisfaction, and the need for additional pain medications. The trial is set to be conducted over one year at the Post Graduate Institute of Dental Sciences in Rohtak, Haryana.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with classical Trigeminal Neuralgia without concomitant pain.
Not a fit: Patients who are pregnant, lactating, or have hepatic or renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective pain management option for patients with Trigeminal Neuralgia.
How similar studies have performed: There have been few trials evaluating the efficacy of Pregabalin in classical Trigeminal Neuralgia, indicating that this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * Patients diagnosed with Trigeminal neuralgia with classical types without concomitant pain as per ICHD-II. * Patient's consent for participation in this study. EXCLUSION CRITERIA * Pregnant and lactating women * Patients on anti-depressants like sodium valproate * History of excessive alcohol intake * Hepatic or renal insufficiency * Known tolerance/allergy to study drug * Non -compliant during screening period * Any other hepatic microsomal enzyme inhibitors (to avoid risk for toxicity)
Where this trial is running
Rohtak, Haryana
- Pgids — Rohtak, Haryana, India (Recruiting)
Study contacts
- Principal investigator: Shifa Akhtar, BDS — Post Graduate Institute of Dental Sciences ,Rohtak
- Study coordinator: Sanjay Tewari, MDS
- Email: principalpgids@gmail.com
- Phone: 09416259534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.