Skip to content

A clinical trial to study the effects of two drugs, Lacosamide and Pregabalin in patients with Neuropathic pain

Comaparative Effectivness of Lacosamide and Pregabalin in patients diagnosed with Neuropathic Pain : A Randomized, Controlled, Open Label Trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023953
Enrollment
60
Registered
2020-03-13
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: G63- Polyneuropathy in diseases classified elsewhere

Interventions

Intervention1: Lacosamide: Lacosamide 50mg BD , oral, initially for 1 week followed by 100mg BD,oral, for 3 months Control Intervention1: Pregabalin: Pregabalin 75mg OD , Oral for 3 months

Sponsors

SRM College of Pharmacy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with definite or probable neuropathic pain for more than 3 months. Patients who are willing to give informed consent

Exclusion criteria

Exclusion criteria: Patient with concomitant pain syndrome that could affect the pain evaluation such fibromyalgia. Patients with serious concurrent systemic disease such as liver problems, severe renal impairment, malignancy. Patients with a history of cardiac arrhythmias or taking antiarrhythmic drugs Patients with a resting heart rate of less than 55 beats/min or greater than 100 beats/min on electrocardiogram (ECG) screening Patients on concomitant treatment with antidepressants, other anticonvulsants and opioids that could not be discontinued. Pregnant women and lactating mothers. Drug-induced neuropathic pain. Patients who are not willing to give informed consent.

Design outcomes

Primary

MeasureTime frame
The individual change in NRS indicating analgesic effect of lacosamideTimepoint: Every 2 weeks after the drug administration.

Secondary

MeasureTime frame
Difference in the pain score between lacosamide and pregabalin along with evaluation of quality of life of patients and safety assessment of lacosamide for clinical use in neuropathic pain patients. Timepoint: Towards the end of the study.

Countries

India

Contacts

Public ContactMs Fatema Juzer Haji

SRM College of Pharmacy

jagapharmd2013@gmail.com7449277556

Outcome results

None listed

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