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

NCT03590197 | Completed Phase 4

• 1 other identifier: IEC/AIIMSBBSR/PGTh/18-19/02
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Generalized Epilepsy

Keywords

Melatonin; Neuron-specific Enolase; Responder rate

Outcome Measures

Primary Outcomes (1)

• Change in Responder Rate from baseline

  Responder rate is defined as percentage of patients having ≥50% reduction in seizure frequency.

  Baseline, 8 weeks

Secondary Outcomes (6)

• Change in seizure severity from baseline

  Baseline , 8 weeks

• Change in neuronal damage from baseline

  Baseline, 8 weeks

• Change in sleep quality from the baseline

  Baseline, 8 weeks

• Change in day time sleepiness from the baseline

  Baseline, 8 weeks

• Change in antioxidant property from the baseline

  Baseline, 8 weeks

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

The patients in Control Arm will receive placebo with valproate (20 mg/kg).

Other: Placebo

Melatonin Arm

EXPERIMENTAL

The Experimental Arm will receive tablet melatonin as an add-on to valproate. Melatonin will be prescribed 3 mg/day to the patients and will be advised to take 30 minutes before bedtime.

Drug: Melatonin 3 mg

Interventions

Melatonin 3 mg DRUG

Melatonin 3 mg/ day with Valproate

Melatonin Arm

Placebo OTHER

Placebo with Valproate

Control Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences (AIIMS)

Bhubaneswar, Odisha, 751019, India

Location

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MeSH Terms

Conditions

Epilepsy, Generalized

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Debasish Hota, D.M

  AIIMS, Bhubaneswar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The recruited patients will be randomized by simple randomization into two treatment groups using computer-generated random codes. The random allocation code of the participants will be generated by PI who will not be involved in the patient recruitment. The codes will be assigned to a sequence of numbers and the numbered stickers will be pasted on the similar looking drug containers. The drug containers will be given to another investigator who will be responsible for patient recruitment. This process ensured allocation concealment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional professor

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 18, 2018
• Study Start: August 6, 2018
• Primary Completion: March 3, 2020
• Study Completion: April 12, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

IN (1)