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
1 other identifier
interventional
132
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2021
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 9, 2021
CompletedStudy Start
First participant enrolled
September 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedOctober 15, 2021
August 1, 2021
3 months
March 21, 2020
October 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in pain scores
Visual analog scale ( scale 0 to 10, where higher score means worst outcome)
10 weeks
Secondary Outcomes (5)
Adverse effects of drugs in both the groups.
10 weeks
Need for adding 2nd line therapy in both the groups.
10 weeks
Number of patients withdrawal from study due to non compliance to drug
10 weeks
Treatment satisfaction in both the groups.
10 weeks
Quality of life in both the groups.
10 weeks
Study Arms (2)
Oxcarbazepine GROUP
EXPERIMENTALOxcarabazepine 150mg BD starting dose \& will be increased if the patient is not relieved
Carbamzepine GROUP
ACTIVE COMPARATORcarbamazepine 100mg BD initial dose \& will be increased if the patient is not relieved
Interventions
oxcarbazepine 150mg BD initial dose , followup will be done at 15days, 6weeks, 10 weeks interval
carbamazepine 100mg BD initial dose, follow up will be done 2weeks, 6 weeks \& 10weeks
Eligibility Criteria
You may qualify if:
- Clinically proven cases of primary trigeminal neuralgia.
- Patients who are willing to participate in the study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
PGIDS
Rohtak, Haryana, 124001, India
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2020
First Posted
August 9, 2021
Study Start
September 18, 2021
Primary Completion
December 31, 2021
Study Completion
January 31, 2022
Last Updated
October 15, 2021
Record last verified: 2021-08