Evaluation of the effectiveness of melatonin add on to the routine anti-epileptic treatment of epileptic patients compared with placebo
Design
This study is a randomized, double-blind, placebo-controlled clinical trial that recruited patients from Vali-Asr Hospital (Zanjan, Iran). The study was conducted in accordance with the Declaration of Helsinki and International Council for Harmonization Good Clinical Practice guidelines and approved by the independent ethics committee at Zanjan University of Medical Sciences before patient enrollment was commenced.
Settings and conduct
This study is a randomized, double-blind, placebo-controlled clinical trial that recruited patients from Vali-Asr Hospital (Zanjan, Iran). All patients and individuals involved in data collection will be blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria: Adult patients (18 ≤ Ages ≤ 60 years old) with diagnosed idiopathic generalized tonic-clonic seizure and a history of 1-4 episodes of seizure within 4 months ago, which had a therapeutic level of anti-epileptic drugs(Valproate).
Exclusion criteria: 1. history of any recent traumatic brain injury 2. cerebral ischemia/TIA/stroke 3. patients with neuroendocrinal tumors 4. history of any invasive neurosurgical/non-invasive neuropsychiatric procedure 5. Pregnant women 6. patients with a history of allergy to valproate or melatonin 7. patients with drug/alcohol abuse 8. patients with any hepatic dysfunction.
Intervention groups
patients prescribed 3mg melatonin tablet (add-on valproate) single dose daily, 1hour before bedtime and continued for 8 weeks
Main outcome variables
The severity of attacks; Frequency of attacks; sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101209005352N4
Registration date:2021-02-18, 1399/11/30
Registration timing:retrospective
Last update:2021-02-18, 1399/11/30
Update count:0
Registration date
2021-02-18, 1399/11/30
Registrant information
Name
Mehdi Maghbooli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2576
Email address
m.maghbooli@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-17, 1396/07/25
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
2017-10-24, 1396/08/02
Actual recruitment end date
2019-11-21, 1398/08/30
Trial completion date
2020-02-09, 1398/11/20
Scientific title
Evaluation of efficacy of Melatonin add on routine anti-epileptic drug regimen versus placebo in adult epileptic patients
Public title
Melatonin add on anti epileptic drug
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18_45 years
1_4 general idiopathic tonic-clonic seizure attacks in the last 4 months
Patients with a therapeutic level anti epileptic drugs
Exclusion criteria:
Patient dissatisfaction
Patients are intubation
Loss of consciousness
Patients without a therapeutic level anti epileptic drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to the melatonin and placebo groups with a 1:1 ratio. The blocking method will be used to randomize the allocation of samples. To do this, a computer coding system is used. Each patient will be assigned a random 6-digit code, which will be associated with the same code on a bottle of drug. Only the nurse who fills the bottles will know the contents and the relevant code. This nurse will have no other role in the study. The placebo and melatonin pill will look the same.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients and physicians and all personnel involved in the data collection process will be unaware of the medicinal nature of the containers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Gavazang
City
Zanjan
Province
Zanjan
Postal code
49123-56212
Approval date
2017-10-17, 1396/07/25
Ethics committee reference number
IR.ZUMS.REC.1396.180
Health conditions studied
1
Description of health condition studied
seizure
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
Frequency and severity of seizures
Timepoint
After 8 and 18 weeks of treatment
Method of measurement
According to Chalfont questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Melatonin (patients prescribed 3mg melatonin tablet (add-on valproate) single dose daily, 1 hour before bedtime and continued for 8 weeks.)
Category
Treatment - Drugs
2
Description
Control group: Placebo (patients prescribed placebo tablet (add-on valproate) single dose daily, 1 hour before bedtime and continued for 8 weeks.)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital (Zanjan. Iran)
Full name of responsible person
Dr Mehdi Maghbooli
Street address
Gvazang
City
Zanjan
Province
Zanjan
Postal code
49125649515
Phone
+98 24 3314 0233
Email
m.maghbooli@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Zanjan University of Medical Sciences
Street address
Gavazang
City
Zanjan
Province
Zanjan
Postal code
۴۹۱۲۶-۴۹۵۱۵
Phone
+98 24 3314 0233
Email
m.maghbooli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehdi Maghbooli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Vali-e-Asr Hospital. Neurology Department
City
Zanjan
Province
Zanjan
Postal code
4912649515
Phone
+98 24 3314 0233
Email
m.maghbooli@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehdi Maghbooli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Neurology Department, Vali-e-Asr Hospital.
City
Zanjan
Province
Zanjan
Postal code
4912649515
Phone
+98 24 3314 0233
Email
m.maghbooli@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehdi Maghbooli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Neurology department, Vali-e-Asr Hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4912649515
Phone
+98 24 3347 2576
Fax
Email
m.maghbooli@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available