Trial on Management of Trigeminal Neuralgia

Phase 4

Recruiting

• Conditions: Cluster headaches and other trigeminal autonomic cephalgias (TAC),

• Registration Number: CTRI/2020/03/024368
• Lead Sponsor: Maulana Azad Institute of Dental Sciences

Brief Summary

This is a Randomized clinical trial on patients with Trigeminal Neuralgia. After selecting patients, they will be randomized in 5 groups as follows:

Group A: Carbamezepine starting from 200 mg/day escalating to maximum 1200 mg/day

Group B: Lamotigrine 50 mg daily orally upto maximum of 200 mg/day

Group C: Pregablin 75mg daily upto maximum of 300 mg/day

Group D: Duloxetine 40 mg/day upto maximum of 120 mg/day

Group E: Gabapentin 300 mg/day upto maximum of 1200 mg/day



All patients will be followed for 2 months followed by drug free period of 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-04
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1.Patients with definite diagnosis of TN according to the criteria of the International Headache Society (HIS) [HIS 3 with ICD- 10 (G44.0) coding] 2.Age-18-70 years 3.Sex – both male and female 4.Signed informed consent prior to entering study.

Exclusion Criteria

• 1.Patients who had undergone invasive treatment for TN during the past 1 year preceding to inclusion.
• 2.Pregnant/ lactating women (risk for teratogenicity), 3.Patients on antidepressants like sodium valproate or any other hepatic microsomal enzyme inhibitors (to avoid risk for toxicity); 4.History of excessive alcohol intake, hepatic or renal insufficiency or a known intolerance/allergy to study drugs 5.Those who were found to be non-compliant during the screening period (owing to psychological or logistic reasons) 6.Those who on MRI are found to have intranuclear lesion (Secondary & classical TN).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Three parameters to assess changes in pain perception, quantitatively:	Baseline | 15 days | 4 weeks | 8 weeks
(a) Total number of pain episodes (on a scale of 1- none to 6- more than 20 episodes);	Baseline | 15 days | 4 weeks | 8 weeks
(b) Severity of pain (on VAS scale) and	Baseline | 15 days | 4 weeks | 8 weeks
(c) Degree of relief obtained (1-complete to 5- no relief).	Baseline | 15 days | 4 weeks | 8 weeks
2.Any improvement in conduct of daily activities like brushing, washing face and eating (using Brief Pain Inventory).	Baseline | 15 days | 4 weeks | 8 weeks
3.Adverse drug Reactions/ Adverse events	Baseline | 15 days | 4 weeks | 8 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse drug Reactions/ Adverse events	15 days

Trial Locations

Locations (1)

Maulana Azad Institute of Dental Sciences; 🇮🇳 Central, DELHI, India

Maulana Azad Institute of Dental Sciences

🇮🇳Central, DELHI, India

Dr Shikha

Principal investigator

9910419028

calmshikhs@yahoo.com