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:
Participant gender:
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
Details
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar