Effect of Melatonin on Seizure Outcome, Neuronal Damage and Quality of Life in Patients With Generalized Epilepsy
NCT ID: NCT03590197
Last Updated: 2020-09-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
104 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-06
Study Completion Date
2020-04-12
Brief Summary
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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.
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Detailed Description
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Epilepsy is a chronic disabling neurologic condition which often leads to numerous adverse long-term neurologic complications, such as behavioural and cognitive deficits, increased susceptibility to recurrent seizures, and neuronal injury or death. Cognitive dysfunction, depression, anxiety and sleep disorders are some of the highly prevalent and most debilitating complications of epilepsy. Despite the abundance of antiepileptic drugs (AEDs), even after long-term treatment of 6-8 years, 30% of patients continue having seizures. This group of patients requires a more aggressive treatment, since monotherapy fails to control seizures, considering the fact that the number of seizures is the single most important predictive factor for both early and long-term remission of seizures. Nevertheless, polytherapy often results in a number of adverse effects. The need for better-tolerated add-on therapy is the need of the hour to overcome this therapeutic hurdle.
Melatonin, an endogenous hormone, acting through MT1 and MT2 receptors exert a depressive effect on brain excitability and have been shown to exert an anticonvulsant activity in various animal models. In some clinical trials also it has been found that add-on melatonin therapy improves the clinical outcome. Uberoset al evaluated the sleep-wake pattern, plasma melatonin levels and the urinary excretion of its metabolite among children with severe epileptic disorders, before and after a therapeutic trial with melatonin. They found sleep efficiency was significantly higher and better controls of convulsive episodes were achieved with among patients who received melatonin. Goldberg-Stern et aland Elkhayat et al concluded that melatonin could be effective and safe for decreasing seizure frequency and severity in patients with intractable epilepsy. Gupta et al found that melatonin has the potential to improve quality of life in pediatric epilepsy because of its beneficial effects on sleep, its wide safety window, and its ability to cross the blood-brain barrier. In another study by Jain SV et al melatonin resulted in a statistically significant decrease in sleep onset latency and wakefulness after sleep onset. Guptaet al also concluded that add-on melatonin can be of promise in the pharmacotherapy of pediatric epilepsy and as an adjunct, can be a putative neuroprotector in conditions involving oxidative stress like epilepsies. Dabak et al and Brazil et measured melatonin in febrile seizure and temporal lobe epilepsy and found to be lower in epilepsy in comparison to the controls.
Our literature review reveals that till date most of the clinical studies on the effect of melatonin in epilepsy have been conducted in the pediatric population and there is no clinical trial done on its effect on seizure outcome, neuroprotective effect, sleep and circadian rhythm and quality of life in adult patients with epilepsy. So the present randomized clinical trial has been designed to fill the knowledge gap and evaluate the effect of add-on melatonin on seizure severity, neuronal damage and sleep quality in adult patients suffering from a generalized seizure.
Melatonin, an endogenous hormone, acting through MT1 and MT2 receptors exert a depressive effect on brain excitability and have been shown to exert an anticonvulsant activity in various animal models. In some clinical trials also it has been found that add-on melatonin therapy improves the clinical outcome. Uberoset al evaluated the sleep-wake pattern, plasma melatonin levels and the urinary excretion of its metabolite among children with severe epileptic disorders, before and after a therapeutic trial with melatonin. They found sleep efficiency was significantly higher and better controls of convulsive episodes were achieved with among patients who received melatonin. Goldberg-Stern et aland Elkhayat et al concluded that melatonin could be effective and safe for decreasing seizure frequency and severity in patients with intractable epilepsy. Gupta et al found that melatonin has the potential to improve quality of life in pediatric epilepsy because of its beneficial effects on sleep, its wide safety window, and its ability to cross the blood-brain barrier. In another study by Jain SV et al melatonin resulted in a statistically significant decrease in sleep onset latency and wakefulness after sleep onset. Guptaet al also concluded that add-on melatonin can be of promise in the pharmacotherapy of pediatric epilepsy and as an adjunct, can be a putative neuroprotector in conditions involving oxidative stress like epilepsies. Dabak et al and Brazil et measured melatonin in febrile seizure and temporal lobe epilepsy and found to be lower in epilepsy in comparison to the controls.
Our literature review reveals that till date most of the clinical studies on the effect of melatonin in epilepsy have been conducted in the pediatric population and there is no clinical trial done on its effect on seizure outcome, neuroprotective effect, sleep and circadian rhythm and quality of life in adult patients with epilepsy. So the present randomized clinical trial has been designed to fill the knowledge gap and evaluate the effect of add-on melatonin on seizure severity, neuronal damage and sleep quality in adult patients suffering from a generalized seizure.
Conditions
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Generalized Epilepsy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
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.
Study Groups
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Control Arm
The patients in Control Arm will receive placebo with valproate (20 mg/kg).
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
Placebo with Valproate
Melatonin Arm
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.
Group Type
EXPERIMENTAL
Melatonin 3 mg
Intervention Type
DRUG
Melatonin 3 mg/ day with Valproate
Interventions
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Melatonin 3 mg
Melatonin 3 mg/ day with Valproate
Intervention Type
DRUG
Placebo
Placebo with Valproate
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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All India Institute of Medical Sciences, Bhubaneswar
OTHER
Sponsor Role
lead
Responsible Party
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RITUPARNA MAITI
Additional professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Debasish Hota, D.M
Role: STUDY_CHAIR
AIIMS, Bhubaneswar
Locations
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All India Institute of Medical Sciences (AIIMS)
Bhubaneswar, Odisha, India
Site Status
Countries
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India
References
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Cramer JA, Perrine K, Devinsky O, Bryant-Comstock L, Meador K, Hermann B. Development and cross-cultural translations of a 31-item quality of life in epilepsy inventory. Epilepsia. 1998 Jan;39(1):81-8. doi: 10.1111/j.1528-1157.1998.tb01278.x.
Reference Type
BACKGROUND
Vimala PV, Bhutada PS, Patel FR. Therapeutic potential of agomelatine in epilepsy and epileptic complications. Med Hypotheses. 2014 Jan;82(1):105-10. doi: 10.1016/j.mehy.2013.11.017. Epub 2013 Nov 21.
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RESULT
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RESULT
MacDonald BK, Johnson AL, Goodridge DM, Cockerell OC, Sander JW, Shorvon SD. Factors predicting prognosis of epilepsy after presentation with seizures. Ann Neurol. 2000 Dec;48(6):833-41.
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RESULT
Yalyn O, Arman F, Erdogan F, Kula M. A comparison of the circadian rhythms and the levels of melatonin in patients with diurnal and nocturnal complex partial seizures. Epilepsy Behav. 2006 May;8(3):542-6. doi: 10.1016/j.yebeh.2005.12.015. Epub 2006 Mar 9.
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RESULT
Costa-Lotufo LV, Fonteles MM, Lima IS, de Oliveira AA, Nascimento VS, de Bruin VM, Viana GS. Attenuating effects of melatonin on pilocarpine-induced seizures in rats. Comp Biochem Physiol C Toxicol Pharmacol. 2002 Apr;131(4):521-9. doi: 10.1016/s1532-0456(02)00037-6.
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RESULT
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Lima E, Cabral FR, Cavalheiro EA, Naffah-Mazzacoratti Mda G, Amado D. Melatonin administration after pilocarpine-induced status epilepticus: a new way to prevent or attenuate postlesion epilepsy? Epilepsy Behav. 2011 Apr;20(4):607-12. doi: 10.1016/j.yebeh.2011.01.018. Epub 2011 Mar 30.
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RESULT
Yahyavi-Firouz-Abadi N, Tahsili-Fahadan P, Riazi K, Ghahremani MH, Dehpour AR. Involvement of nitric oxide pathway in the acute anticonvulsant effect of melatonin in mice. Epilepsy Res. 2006 Feb;68(2):103-13. doi: 10.1016/j.eplepsyres.2005.09.057. Epub 2006 Jan 10.
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RESULT
Goldberg-Stern H, Oren H, Peled N, Garty BZ. Effect of melatonin on seizure frequency in intractable epilepsy: a pilot study. J Child Neurol. 2012 Dec;27(12):1524-8. doi: 10.1177/0883073811435916. Epub 2012 Feb 28.
Reference Type
RESULT
Gupta M, Aneja S, Kohli K. Add-on melatonin improves quality of life in epileptic children on valproate monotherapy: a randomized, double-blind, placebo-controlled trial. Epilepsy Behav. 2004 Jun;5(3):316-21. doi: 10.1016/j.yebeh.2004.01.012.
Reference Type
RESULT
Singer MA. Effects of furosemide and ethacrynic acid on cation transport across phospholipid bilayer membranes. Can J Physiol Pharmacol. 1974 Oct;52(5):930-41. doi: 10.1139/y74-122. No abstract available.
Reference Type
RESULT
Gupta M, Aneja S, Kohli K. Add-on melatonin improves sleep behavior in children with epilepsy: randomized, double-blind, placebo-controlled trial. J Child Neurol. 2005 Feb;20(2):112-5. doi: 10.1177/08830738050200020501.
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RESULT
Gupta M, Gupta YK, Agarwal S, Aneja S, Kohli K. A randomized, double-blind, placebo controlled trial of melatonin add-on therapy in epileptic children on valproate monotherapy: effect on glutathione peroxidase and glutathione reductase enzymes. Br J Clin Pharmacol. 2004 Nov;58(5):542-7. doi: 10.1111/j.1365-2125.2004.02210.x.
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AlAhmed S, Herbert J. Effect of agomelatine and its interaction with the daily corticosterone rhythm on progenitor cell proliferation in the dentate gyrus of the adult rat. Neuropharmacology. 2010 Nov;59(6):375-9. doi: 10.1016/j.neuropharm.2010.05.008. Epub 2010 Jun 1.
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RESULT
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Reference Type
RESULT
Other Identifiers
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IEC/AIIMSBBSR/PGTh/18-19/02
Identifier Type: -
Identifier Source: org_study_id
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