| CTRI Number |
CTRI/2024/08/072001 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Melatonin in Epilepsy: Trial of Melatonin as add on anti-seizure medication in Epilepsy patients |
|
Scientific Title of Study
|
Efficacy of add on Melatonin on seizure outcome in Focal drug resistant epilepsy patients : A Randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjari Tripathi |
| Designation |
Professor, HOD |
| Affiliation |
AIIMS,DELHI,INDIA |
| Address |
Department of Neurology, Cardiothoracic sciences centre, Aiims, New delhi
South
DELHI
110029
India |
| Phone |
8929919736 |
| Fax |
|
| Email |
manjari.tripathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Uppula Supriya |
| Designation |
senior resident |
| Affiliation |
AIIMS,DELHI,INDIA |
| Address |
Department of Neurology, Cardiothoracic sciences centre, Aiims, New delhi
South
DELHI
110029
India |
| Phone |
7601031906 |
| Fax |
|
| Email |
supriyauppula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Uppula Supriya |
| Designation |
senior resident |
| Affiliation |
AIIMS,DELHI,INDIA |
| Address |
Department of Neurology, Cardiothoracic sciences centre, Aiims, New delhi
Department of Neurology, Cardiothoracic sciences centre, Aiims, New delhi
South
DELHI
110029
India |
| Phone |
07601031906 |
| Fax |
|
| Email |
supriyauppula@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Uppula Supriya |
| Address |
Department of Neurology, Cardiothoracic and Neurosciences centre, Aiims, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Uppula Supriya |
AIIMS, New Delhi |
Department of Neurology, Cardiothoracic sciences centre, Aiims, New Delhi
South
DELHI |
07601031906
supriyauppula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G400||Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, (2) ICD-10 Condition: G402||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, (3) ICD-10 Condition: G401||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin |
Patients in the intervention arm will receive add on melatonin 3 mg daily orally for 12 weeks in addition to the existing drug regimen. |
| Comparator Agent |
placebo |
patients in the control group will receive placebo orally daily for 12 weeks in addition to existing drug regimen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Focal drug resistant epilepsy patients on stable treatment during previous month
2. Recent seizure attacks [ ≥ 3 seizures per month / clusters of seizures] |
|
| ExclusionCriteria |
| Details |
1.Primary sleep disorders like severe OSA, narcolepsy, cataplexy
2. Major depression
3. Neuroendocrine tumors
4. Rapidly growing brain tumors
5. Uncontrolled diabetes
6. Hepatic dysfunction
7. Severe asthma
8. Infertility
9. Pregnancy and nursing women |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| responder rate |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| seizure free rate, seizure severity, sleep parameters, quality of life |
3 months |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study focal drug-resistant epilepsy patients will be randomized into intervention and control groups. patients in the intervention group receive melatonin and those in the control group receive placebo. patients will be followed up after 3 months to see the responder rate. other secondary outcomes like seizure free rate, seizure severity reduction, sleep parameters, quality of life will be assessed. This study is aimed at evaluating the efficacy of melatonin as add on antiepileptic in focal drug-resistant epilepsy patients. |