Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients

Evaluation of Efficacy of Pregabalin as an Add on Therapy With Carbamazepine in Patients of Trigeminal Neuralgia"- A Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Drug: Pregabalin and Carbamazepine; Drug: Carbamazepine

Detailed Description

AIM

Evaluation of Efficacy of Pregabalin as an add on therapy with Carbamazepine in patients with trigeminal neuralgia.

OBJECTIVES

Primary objectives-

1. To compare the change in pain intensity in both groups.

Secondary objectives-

1. To evaluate the mean dose of carbamazepine used in both the groups.
2. To evaluate quality of life.
3. To evaluate the patient satisfaction in both groups.
4. To evaluate the need for additional pain medicine in both groups.

STUDY DESIGN

A randomized clinical trial will be conducted in department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.

STUDY SETTING

Hospital based study - Patients diagnosed with Trigeminal neuralgia will be recruited in study from regular OPD of the department of Oral Medicine and Radiology.

STUDY PERIOD

This study will be completed in 1 year.

STUDY SUBJECTS

Patients diagnosed with classical Trigeminal neuralgia will be recruited in the study from regular OPD of the Department of Oral Medicine and Radiology, PGIDS, Rohtak, Haryana. A total of 50 patients would compromise; Test group (n=25) and Control group (n=25).

METHOD OF RECRUITMENT Patient will be randomly allocated to test and control groups by using simple random sampling.

INTERVENTION

Clinically and MRI proven cases of classical Trigeminal neuralgia will be randomly and equally divided into test group and control group. The selected subjects will be divided into two groups.

TEST GROUP

Test group will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks.

CONTROL GROUP

In control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain.

Both groups will be assessed for the following parameters: intensity of pain, at the baseline ,1st week, 2nd week, 4th week ,6th week and 8th weeks interval.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanjay Tewari, MDS; Phone Number: 09416259534; Email: principalpgids@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS
      • Contact: DR. Lavina Arya, MDS; Phone Number: 09212795285; Email: aryalavina@gmail.com
      • Contact: Dr. Ambika Gupta, MDS; Phone Number: 09315903300; Email: drambika79@rediffmail.com
      • Principal Investigator: Shifa Akhtar, MDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group-1; Carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need	Drug: Pregabalin and Carbamazepine; Carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need; Other Names: Test group
Active Comparator: Control group; Carbamazepine with dose of Carbamazepine being titrated as per patients's need	Drug: Carbamazepine; Carbamazepine with dose of Carbazmaepine being titrated as per patients's need; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	0- no pain 10-worst pain possible .Higher score means worst outcome	0-8 weeks
Brief pain inventory	1-4=mild pain. 07-10 =severe pain. Higher score means worst outcome	0-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean dose of carbamazepine	lower dose requirement of carbamazepine means better outcome	0-8 weeks
Patient global impression of scale	1- very much improved and 7-very much worse .Higher score means worst outcome	0-8 weeks
Liverpool scale	Scale meant for adverse events score ranging from 19 -76 with higher score indicating greater adverse event related to drug	0-8 weeks

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Shifa Akhtar, BDS, Post Graduate Institute of Dental Sciences ,Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Sodium Channel Blockers; Antimanic Agents; Cytochrome P-450 Enzyme Inducers; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Cytochrome P-450 CYP3A Inducers; Pregabalin; Carbamazepine
• Other Study ID Numbers: Shifa OMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No