Trial on Management of Trigeminal Neuralgia

Efficacy of various medical treatmentmodalities in management of Trigeminal Neuralgia: A Randomized Clinical Controlled Trial - None

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/024368

Enrollment

Registered

2020-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G440- Cluster headaches and other trigeminal autonomic cephalgias (TAC)

Interventions

Intervention1: Tab Lamotigrine: 50 mg Daily orally upto maximum dose of 200 mg/day Intervention2: Tab Pregablin: 75 mg daily orally upto maximum dose of 300 mg/day Intervention3: Tab Gabapentin: 300 m

Eligibility

Inclusion criteria

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 â?? both male and female 4. Signed informed consent prior to entering study

Exclusion criteria

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)

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Adverse drug Reactions/ Adverse eventsTimepoint: 15 days 4 weeks 8 weeks	—

Countries

India

Contacts

Public ContactDr Sujoy Ghosh

BDS, MDS

drsujoyghosh@gmail.com9582911387

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026