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

NCT06357260 | Recruiting DMC

• 1 other identifier: Shifa OMR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mean dose of carbamazepine

  0-8 weeks

• Patient global impression of scale

  0-8 weeks

• Liverpool scale

  0-8 weeks

Study Arms (2)

Test group-1

EXPERIMENTAL

Carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need

Drug: Pregabalin and Carbamazepine

Control group

ACTIVE COMPARATOR

Carbamazepine with dose of Carbamazepine being titrated as per patients's need

Drug: Carbamazepine

Interventions

Pregabalin and Carbamazepine DRUG

Carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need

Also known as: Test group

Test group-1

Carbamazepine DRUG

Carbamazepine with dose of Carbazmaepine being titrated as per patients's need

Also known as: Control group

Control group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Pregabalin; Carbamazepine; Control Groups

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Shifa Akhtar, BDS

  Post Graduate Institute of Dental Sciences ,Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Tewari, MDS

CONTACT

09416259534; principalpgids@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Test group-1 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 all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: April 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)