Generalized EpilepsyPhase 4NCT03590197
Effect of Melatonin on Seizure Outcome, Neuronal Damage and Quality of Life in Patients With Generalized Epilepsy
A Phase 4 study testing Melatonin 3 mg in people with Generalized Epilepsy, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Generalized Epilepsy
- What is being tested?
- Melatonin 3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteIndia
- Study dates
- 6 Aug 2018to 12 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Patients with a history of allergy to valproate, melatonin or other melatonin agonists.
- Patients with drug/alcohol abuse.
- Patients with any hepatic dysfunction.
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences (AIIMS)
Bhubaneswar, Odisha, 751019
About this study
Official title: Effect of Melatonin on Seizure Outcome, Neuronal Damage and Quality of Life in Patients With Generalized Epilepsy: A Randomized, add-on Placebo-controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Generalized Epilepsy
- Being tested
- Melatonin 3 mg, Placebo
- Keywords
- Melatonin, Neuron-specific Enolase, Responder rate
- Medical subject headings
- Epilepsy, Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 mgDrug
Melatonin 3 mg/ day with Valproate
PlaceboOther
Placebo with Valproate
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | The patients in Control Arm will receive placebo with valproate (20 mg/kg). Receives: 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. Receives: Drug: Melatonin 3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Responder Rate from baseline
Responder rate is defined as percentage of patients having ≥50% reduction in seizure frequency.
Measured: Baseline, 8 weeks
Secondary outcomes (6)
Change in seizure severity from baseline
The change in seizure severity in terms of change in Chalfont-National Hospital seizure severity scale (NHS3)
Measured: Baseline , 8 weeks
Change in neuronal damage from baseline
The change in neuronal damage in terms of change in serum NSE (Neuron-specific Enolase) level
Measured: Baseline, 8 weeks
Change in sleep quality from the baseline
The change in sleep quality in terms of change in Pittsburgh sleep quality index (PSQI) score
Measured: Baseline, 8 weeks
Change in day time sleepiness from the baseline
The change in daytime sleepiness in terms of change in Epworth sleepiness scale
Measured: Baseline, 8 weeks
Change in antioxidant property from the baseline
The change in antioxidant property in terms of change in serum glutathione reductase
Measured: Baseline, 8 weeks
Change in the quality of life from the baseline
The change in the quality of life in terms of change in Quality of Life in Epilepsy Inventory (QOLIE-31)
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start6 Aug 2018
- Primary completion3 Mar 2020
- Study completion12 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Generalized EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Debasish Hota, D.M, Study chair, AIIMS, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590197
- Sponsor's protocol ID
- IEC/AIIMSBBSR/PGTh/18-19/02
- Status last verified
- Sep 2020
- First submitted
- 6 Jul 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9578017Vimala 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.
PubMed 24314750Cockerell OC, Sander JW, Shorvon SD. Remission of epilepsy. The NGPS. National General Practice Study of Epilepsy. Lancet. 1995 Nov 4;346(8984):1228. doi: 10.1016/s0140-6736(95)92933-9. No abstract available.
PubMed 7475682MacDonald 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.
PubMed 11117539Yalyn 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.
PubMed 16524783Costa-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.
PubMed 11976067Borowicz KK, Kaminski R, Gasior M, Kleinrok Z, Czuczwar SJ. Influence of melatonin upon the protective action of conventional anti-epileptic drugs against maximal electroshock in mice. Eur Neuropsychopharmacol. 1999 Mar;9(3):185-90. doi: 10.1016/s0924-977x(98)00022-4.
PubMed 10208286Lima 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.
PubMed 21454134Yahyavi-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.
PubMed 16406488Goldberg-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.
PubMed 22378657Gupta 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.
PubMed 15145300Singer 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.
PubMed 4425994Gupta 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.
PubMed 15794175Gupta 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.
PubMed 15521903Bertaina-Anglade V, Drieu-La-Rochelle C, Mocaer E, Seguin L. Memory facilitating effects of agomelatine in the novel object recognition memory paradigm in the rat. Pharmacol Biochem Behav. 2011 Jun;98(4):511-7. doi: 10.1016/j.pbb.2011.02.015. Epub 2011 Feb 22.
PubMed 21352847
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin on Seizure Outcome, Neuronal Damage and Quality of Life in Patients With Generalized Epilepsy: A Randomized, add-on Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03590197
- Acronym / sponsor ID
- IEC/AIIMSBBSR/PGTh/18-19/02
- Conditions
- Generalized Epilepsy
- Keywords
- Melatonin, Neuron-specific Enolase, Responder rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 12 Apr 2020 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Other: PlaceboThe patients in Control Arm will receive placebo with valproate (20 mg/kg). |
| Melatonin Arm | Experimental | Drug: Melatonin 3 mgThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 3 mgMelatonin 3 mg/ day with Valproate | Drug | Melatonin Arm |
| PlaceboPlacebo with Valproate | Other | Control Arm |
Primary outcome
Change in Responder Rate from baseline
Time frame: Baseline, 8 weeks
Responder rate is defined as percentage of patients having ≥50% reduction in seizure frequency.
6 secondary outcomes
Change in seizure severity from baseline
Time frame: Baseline , 8 weeks
Change in neuronal damage from baseline
Time frame: Baseline, 8 weeks
Change in sleep quality from the baseline
Time frame: Baseline, 8 weeks
Change in day time sleepiness from the baseline
Time frame: Baseline, 8 weeks
Change in antioxidant property from the baseline
Time frame: Baseline, 8 weeks
Change in the quality of life from the baseline
Time frame: Baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Background: PubMed 9578017Cramer 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.
- Results publication: PubMed 24314750Vimala 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.
- Results publication: PubMed 7475682Cockerell OC, Sander JW, Shorvon SD. Remission of epilepsy. The NGPS. National General Practice Study of Epilepsy. Lancet. 1995 Nov 4;346(8984):1228. doi: 10.1016/s0140-6736(95)92933-9. No abstract available.
- Results publication: PubMed 11117539MacDonald 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.
- Results publication: PubMed 16524783Yalyn 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.
- Results publication: PubMed 11976067Costa-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.
- Results publication: PubMed 10208286Borowicz KK, Kaminski R, Gasior M, Kleinrok Z, Czuczwar SJ. Influence of melatonin upon the protective action of conventional anti-epileptic drugs against maximal electroshock in mice. Eur Neuropsychopharmacol. 1999 Mar;9(3):185-90. doi: 10.1016/s0924-977x(98)00022-4.
- Results publication: PubMed 21454134Lima 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.
- Results publication: PubMed 16406488Yahyavi-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.
- Results publication: PubMed 22378657Goldberg-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.
- Results publication: PubMed 15145300Gupta 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.
- Results publication: PubMed 4425994Singer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debasish Hota, D.M study chair
AIIMS, Bhubaneswar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin 3 mg in people with Generalized Epilepsy, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Responder Rate from baseline (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590197, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.