Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial

Comparative Efficacy of Carbamazepine Versus Oxcarbazepine in Treatment of Trigeminal Neuralgia- a Randomized Controlled Clinical Study

Trigeminal neuralgia is a neuropathic facial pain condition, characterized by unilateral paroxysmal pain which can be described as stabbing or electric shock like, in the distribution of one or more divisions of trigeminal nerve which is triggered by innocuous stimuli. The attack is provoked by touching or stimulating these trigger zones. There are various pharmacological drugs present for the treatment of trigeminal neuralgia. Carbamazepine and oxcarbazepine are the first-choice drugs for the treatment of TN. Other drugs include lamotrigine , baclofen , gabapentin, antidepressants , eslicarbazepine , sumatriptan & vixitrigine. The carbamazepine is first choice of drug which has serious side effects including dizziness, memory loss, sleppiness, aplastic anaemia. Oxcarbazepine has similar mechanism of action and found to have lesser adverse events when used in various neuralgias in the place of carbamazepine. But there is still lack of evidence to prove that oxcarbazepine can be used as monotherapy in TN patients.

Study Overview

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

Detailed Description

Trigeminal neuralgia is a neuropathic facial pain condition which is characterised by unilateral paroxysmal pain which is excruciating, short lasting in the distribution territory of trigeminal nerve.(1) Trigeminal neuralgia is oro-facial pain restricted to one or more divisions of the trigeminal nerve. With the exception of Trigeminal Neuralgia caused by Multiple sclerosis, the pain affects one side of the face. It is abrupt in onset and typically lasts only a few seconds (2 min at maximum).Patients may report their pain as arising spontaneously, but these pain paroxysms can always be triggered by innocuous mechanical stimuli or movements. Patients usually do not experience pain between paroxysms. If they do report additional continuous pain, in the same distribution and in the same periods as the paroxysmal pain, they are considered to have Trigeminal Neuralgia with continuous pain. (IASP)(1) Trigeminal neuralgia is mainly classified into three diagnostic categories i.e. Classical, Secondary and Idiopathic. This classification is mainly based on the etiology & pain characteristics. The etiology of Trigeminal Neuralgia is not well understood, but various theories such as Compression of sensory root of trigeminal nerve by arteries & bony exostoses.(4) ,focal demyelination of trigeminal afferents near the entry of the trigeminal root into pons(2)and alteration in the central neural function followed by injury to peripheral nerves (4) are widely accepted.

Trigeminal Neuralgia has a profound effect on quality of life of the patient & expenditure on health (4). Due to the severe intensity of pain, patients avoid touching face, washing face, thus making patient's life disturbing & miserable. Even after so many years of research, it is still a challenge to treat patients suffering from Trigeminal Neuralgia. Treatment can be sub- divided into pharmacological & invasive therapies .

The pharmacological therapy include drugs such as carbamazepine ( 200-1200mg) , oxcarbazepine (300-1800mg) , lamotrigine, Gabapentin , baclofen, eslicarbazepine, sumatriptan, vixotrigine. The pre- surgical procedures like botulinium toxin A & intranasal non-inhaled CO2 have also been sporadically used (1).

A review study discussing the pharmacological options to treat trigeminal neuralgia concluded that carbamazepine & oxcarbazepine are the first choice of drugs(1). Oxcarbazepine showed equal efficacy in reducing pain attacks with better tolerability & less side effects (1) .

A recently conducted study found that carbamazepine is associated with serious side effects including CNS disturbances, somnolence, unbalance, thrombocytopenia, increase level of transaminases while OXC showed similar efficacy with less side effects. CNS disturbances encountered in patients on CBZ were triple to those on OXC & withdrawal from the treatment was also more in patients on CBZ(27%) than on OXC (18%)(12).

OXC has contemporarily been used as monotherapy in epileptic patients (8) & has proven efficacy over the CBZ. In trigeminal neuralgia, though various studies have shown that OXC produce lesser side effects, but none of the studies have compared the efficacy of carbamazepine with oxcarbazepine .

Thus the present study intends to compare the efficacy of oxcarbazepine with carbamazepine as monotherapy in patients suffering from trigeminal neuralgia.

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sanjay Tewari, MDS; Phone Number: 01262283876; Email: principalpgidsrohtak@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS
      • Contact: Dr. Sanjay Tewari, MDS; Phone Number: 01262283876; Email: principalpgids@yahoo.in
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Post Graduate Institute of dental sciences

Participation Criteria

Eligibility Criteria

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

Description

INCLUSION CRITERIA:

• Clinically proven cases of primary trigeminal neuralgia.
• Patients who are willing to participate in the study.

EXCLUSION CRITERIA:

• Intolerance to either of the two drugs
• Medically compromised patients
• Patients with pacemaker
• Patients who have previously undergone surgical treatment for TRIGEMINAL NEURALGIA.
• Patients who are already on pharmacotherapy for TRIGEMINAL NEURALGIA.
• Seizure disorder/ pregnant/ lactating
• Renal/ hepatic impairment
• History of hyponatermia
• Concurrent medication- dilantin, phenytoin

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: Oxcarbazepine GROUP; Oxcarabazepine 150mg BD starting dose & will be increased if the patient is not relieved	Drug: Oxcarbazepine; oxcarbazepine 150mg BD initial dose , followup will be done at 15days, 6weeks, 10 weeks interval; Other Names: LOVAX
Active Comparator: Carbamzepine GROUP; carbamazepine 100mg BD initial dose & will be increased if the patient is not relieved	Drug: Carbamazepine; carbamazepine 100mg BD initial dose, follow up will be done 2weeks, 6 weeks & 10weeks; Other Names: zileuton

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain scores	Visual analog scale ( scale 0 to 10, where higher score means worst outcome)	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects of drugs in both the groups.	side effects will be asked at each visit	10 weeks
Need for adding 2nd line therapy in both the groups.	if pateint is not satisfied with treatment, then 2nd line drug will be used	10 weeks
Number of patients withdrawal from study due to non compliance to drug	Drug tolerability in both the groups	10 weeks
Treatment satisfaction in both the groups.	likert scale is used in both groups 1-5 scale, higher score means better outcome	10 weeks
Quality of life in both the groups.	Oral health impact profile 14 score will be used, higher score means worst outcome	10 weeks

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: March 21, 2020
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: August 1, 2021

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; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Antimanic Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Lipoxygenase Inhibitors; Carbamazepine; Oxcarbazepine; Zileuton
• Other Study ID Numbers: suman008

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