Effect of Melatonin on Seizure Outcome, Neuronal Damage and Quality of Life in Patients With Generalized Epilepsy

• Status: Completed
• Trial end date: 2020-04-12
• Target enrollment: 0
• Participant gender: All

Summary

Epilepsy is one of the most common and frequently encountered neurological conditions that impose a huge burden on the healthcare systems. Despite the abundance of antiepileptic drugs (AEDs) available, 30% of people continue to have seizures even after long-term therapy of 6-8 years. This group of people requires a more aggressive treatment since monotherapy, the first choice scheme, is not sufficient to control seizure and its complications, multiple drug therapy or polytherapy often results in the culmination of unwanted effects. The need for an add-on AEDs with a good safety profile is of utmost importance.The beneficial effects of melatonin on sleep, its wide safety window, and its ability to cross the blood-brain barrier have the potential to improve the quality of life in seizure patients. Various animal studies have suggested that melatonin receptors are the potential targets for anticonvulsant drug development. In animal studies, melatonin was found to suppress generalized seizure and seizure susceptibility and it also has neuroprotection and synapse modulating properties. Some clinical trials mostly on paediatric population also found that melatonin can improve the clinical outcome in epilepsy. Therefore, we have planned to conduct a randomized, add-on placebo-controlled clinical trial on the effect of melatonin on seizure outcome, neuronal damage and quality of life in adult patients with generalized seizure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Treatments: Melatonin; Valproic Acid

Criteria

Inclusion Criteria:

• All patients with the clinical diagnosis of generalized epilepsy with generalised onset motor seizure (ILAE 2017) with a history of an episode of seizure within 72 hours of presentation.

• Patients aged 18-60 years, of either sex.

• Treatment-naive patients or patients who had not taken any treatment for at least 4 weeks before inclusion.

Exclusion Criteria:

• History of any recent traumatic brain injury, cerebral ischemia/TIA/stroke.

• Patients with neuroendocrinal tumors.

• History of any invasive neurosurgical/non-invasive neuropsychiatric procedure.

• Patients who are already under treatment for the presenting conditions.

• Medication history of psychoactive or central nervous system depressant drugs.

• Pregnant and nursing women.

• Patients with a history of allergy to valproate, melatonin or other melatonin agonists.

• Patients with drug/alcohol abuse.

• Patients with any hepatic dysfunction.