Actively Recruiting
Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2024-06-10
50
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated.
CONDITIONS
Official Title
Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with classical trigeminal neuralgia without other types of pain as per ICHD-II
- Patients who provide consent to participate in the study
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients using anti-depressants like sodium valproate
- History of excessive alcohol intake
- Liver or kidney insufficiency
- Known allergy or tolerance to the study drugs
- Non-compliance during screening period
- Use of hepatic microsomal enzyme inhibitors to avoid toxicity risk
AI-Screening
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Trial Site Locations
Total: 1 location
1
PGIDS
Rohtak, Haryana, India, 124001
Actively Recruiting
Research Team
S
Sanjay Tewari, MDS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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