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

April 4, 2024 updated by: Postgraduate Institute of Dental Sciences Rohtak

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

Not yet recruiting

Conditions

Intervention / Treatment

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).

INCLUSION CRITERIA

The following patients will be included in the study:

  1. Patients diagnosed with Trigeminal neuralgia with classical types without concomitant pain as per ICHD-II and MRI proven
  2. Patient's consent for participation in this study.

EXCLUSION CRITERIA

  1. Pregnant and lactating women
  2. Patients on anti-depressants like sodium valproate
  3. History of excessive alcohol intake
  4. Hepatic or renal insufficiency
  5. Known tolerance/allergy to study drug
  6. Non -compliant during screening period
  7. Any other hepatic microsomal enzyme inhibitors (to avoid risk for toxicity)

SAMPLE SIZE The sample size for the study was based on a study by Abid Majeed Rather et al(2021)5. The sample size was calculated assuming equal proportion of success in the two groups with non- inferiority margin set at 15% Additionally type 1 error rate of 5% and statistical power of 80% yielded a sample size of 21 per group Using mean and standard deviation ascertained from previous studies. Sample size was calculated using formula M= 2*(Z(1-a/2) + Z(1-b))2 D2 =2 * (0.72)2 (2.8)2 (.618)2 = 21.20

Adjustment of 10-20% was done to compensate for attrition. The final sample required for each group was increased to 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 (1 week, 2weeks, 4 weeks ,6 weeks and 8 weeks interval.

METHOD OF MEASUREMENT OF OUTCOME OF INTEREST Outcome measures

Primary outcome measures will be

  • VAS assessment of pain.
  • Brief pain inventory assessment of pain.

Secondary outcome measures will be

  1. To evaluate mean dose of carbamazepine used in both the groups
  2. Patient global impression of change.
  3. Brief pain inventory assessment of quality of life.
  4. Liverpool scale for adverse events assessment.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: 1.Patients diagnosed with Trigeminal neuralgia with classical types without concomitant pain as per ICHD-II.

2. Patient's consent for participation in this study.

Exclusion Criteria:

  • 1. Pregnant and lactating women 2. Patients on anti-depressants like sodium valproate 3. History of excessive alcohol intake 4. Hepatic or renal insufficiency 5. Known tolerance/allergy to study drug 6. Non -compliant during screening period 7. Any other hepatic microsomal enzyme inhibitors (to avoid risk for toxicity)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
VAS score
Time Frame: 10-12 months
assessment of pain
10-12 months
Brief pain inventory ● Brief pain inventory assessment of pain. ● Brief pain inventory assessment of pain. Brief pain inventory
Time Frame: 10-12 months
assessment of pain
10-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of change(PGI)
Time Frame: 10-12 months
quality of life
10-12 months
mean dose of carbamazepine
Time Frame: 10-12 months
Pain relief
10-12 months
Liverpool scale
Time Frame: 10-12 months
Adverse event assessment
10-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

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)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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