| CTRI Number |
CTRI/2025/06/088828 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cannabidiol 100 mg/ml Oral Solution as Add-on therapy for Seizures in Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS) |
|
Scientific Title of Study
|
An observational, Prospective, Multicenter Study to evaluate safety of cannabidiol 100 mg/ml oral
solution as add-on therapy in patients with for Seizures Associated with Lennox-Gastaut Syndrome
(LGS) or Dravet Syndrome (DS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ND/MA/22/000140, Version No.00, 09/Sep/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Bhagawan Patil |
| Designation |
Consultant Paediatric Neurologist and Epileptologist |
| Affiliation |
Noble hospital and research centre |
| Address |
Nobel Hospital pvt. Ltd
153, Magarpatta City Road , Hadapsar, Pune
Pune
MAHARASHTRA
411013
India |
| Phone |
9673901863 |
| Fax |
|
| Email |
drsande@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Bhagawan Patil |
| Designation |
Consultant Paediatric Neurologist and Epileptologist |
| Affiliation |
Noble hospital and research centre |
| Address |
Nobel Hospital pvt. Ltd
153, Magarpatta City Road , Hadapsar, Pune
Pune
MAHARASHTRA
411013
India |
| Phone |
9673901863 |
| Fax |
|
| Email |
drsande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati katharia |
| Designation |
Clinical Operations Lead |
| Affiliation |
Sclin soft technologies Pvt, Ltd. |
| Address |
12-5-35/A/6
street 6
Tarnaka
Hyderabad
Hyderabad
TELANGANA
500017
India |
| Phone |
9760147377 |
| Fax |
|
| Email |
swati@sclintech.com |
|
|
Source of Monetary or Material Support
|
| Zenara pharma private Limited
Plot No. 83/B, 84, 87 to 96,
Phase-III, IDA Cherlapally, Hyderabad,
Telangana-500051
|
|
|
Primary Sponsor
|
| Name |
Zenara pharma private Limited |
| Address |
Plot No. 83/B, 84, 87 to 96,
Phase-III, IDA Cherlapally, Hyderabad,
Telangana-500051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smilu Mohanlal |
Aster MIMS hospital |
Department of neurology,
First floor, Room No-174
Mini-Bypass road
Govindapuram(PO)
Calicut
Kerala
673016
Kozhikode
KERALA |
9892071925
drsmilu@gmail.com |
| Dr Sandeep Bhagwan Patil |
Noble Hospital |
Department of Pediatric Neurology,
Ground floor, Room No-12,
153
Magarpatta city road
Hadapsar
Pune
411013
Pune
MAHARASHTRA |
9673901863
drsande@gmail.com |
| Dr Alpana Santosh Kondekar |
Topiwala national medical college and B.Y.L NAIR hospital |
Department of Pediatric Neurology,
first floor, Room No-17
A.L.NAIR Road
Mumbai central
Mumbai
400008
Mumbai
MAHARASHTRA |
8097952226
dralpanakondekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Malabar Institute of Medical sciences |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, TNMC & BYL NAIR CHARITABLE HOSPITAL |
Submittted/Under Review |
| Noble Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cannabidiol 100 mg/ml oral
solution |
Cannabidiol 100mg/ml
given orally for 112 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject aged two to 65 years, Diagnosed with seizers LGS or DS.
2. Established diagnosis of epilepsy, characterized by focal or generalized seizures. All participants will have active epilepsy that requires treatment with anticonvulsant medication.
3. No episodes of seizure clusters of status epilepticus within 30 days prior to entry into the study.
4. Established symptoms of anxiety with functional impairment.
5. Ability to administer medicine orally.
6. Previous subjects who failed at any point to meet continuation criteria and withdraw early may be considered for re-enrolment by the PI on a case by case basis.
7. Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subjects disease process and compliance with treatment.
8. Participants who are sexually active, must agree to sexual abstinence, or, to use an approved birth control method for the full duration of study participation.
9. No active use of CBD products within the 14 days prior to screening visit and commitment to only use study product for duration of the study.
10. Must meet laboratory ranges.
11. Females of child bearing potential(FCBP) must have a negative pregnancy test at screening and baseline. while on investigational product (IP) and for at least 28 days after taking the last dose of investigational product.
|
|
| ExclusionCriteria |
| Details |
1. Baseline lab tests for liver specific transaminase, ALT, over the upper limit of normal (ULN).
2. Clinically significant ECG abnormalities.
3. Previous allergic or hypersensitivity reactions to cannabidiol.
4. No access to a phone or internet to complete remote visits (in person visits acceptable for participants without devices).
5. Active substance abuse or dependence.
6. Presence of psychotic illness or imminent risk of harm to self or others.
7. Current standing use of benzodiazepines (except as "rescue" medicine).
8. Serious unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.
9. Presence of Epilepsy Syndrome such as Sturge-Weber Syndrome that will be more suitable as a candidate in alternate research studies.
10. Participation in a previous experimental drug study within 30 days of baseline visit.
11. Cognitive functional capacity or English literacy that is
insufficient to assure validity of clinical rating scales.
12. Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures.
13. No exclusions for existing AEDs will be absolute, though consideration of additional monitoring will be in place for patients taking clobazam or valproate.
14. Pregnant, planning to become pregnant, breast feeding, or failing to use an appropriate method of contraception.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate via the adverse events (AE) profile
the long term safety and tolerability of Cannabidiol 100 mg/ml as
add-on therapy in children and adults with for Seizures Associated
With Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) |
Day-(-7), Day-1,Day-28, Day-56, Day-84, Day-112, Day-123, Day-151 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Percentage change from baseline in total seizure frequency, percentage of participants achieving 25 percent reduction in seizure frequency , 50 percent reduction in seizure frequency, 75 percent reduction in seizers frequency from baseline.
2) Average number of seizure free days in the last 28 days, longest duration of seizure free days in last 28 days, number of events of status epilepticus.
3) Average maintenance dose of cannabidiol, maximum maintenance dose of cannabidiol, type, dosage, and frequency of concomitant anti seizure medications( ASMs), number of participants reducing, dosage of concomitant medication related epilepsy.
4) Change in adult or child quality of life (QOL), physician global impression of change (PGIC), change in the adult or child behavior check list (ABCL), change in the social communication questionnaire (SCQ). |
week-4, week-12, week-16 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/06/2025 |
| 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="0"
Months="6"
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
|
This is an observational, prospective, multicenter study designed to evaluate the safety of cannabidiol 100 mg/ml oral solution as an add-on therapy for patients with seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS). Patients with LGS or DS who meet the eligibility criteria will be screened at Day -7 for inclusion in the study. Written informed consent or assent will be obtained from all patients prior to any study-related procedures. At screening, demographic data, comprehensive medical history (including details of seizures since diagnosis and all antiepileptic drugs [AEDs] used), and vital signs will be collected. Laboratory assessments, including hematology, biochemistry, urinalysis, and urine pregnancy tests (UPT), will be performed, and an ECG will be conducted. Eligible patients who meet all inclusion criteria and none of the exclusion criteria will be assigned a unique patient number. Following a 7-day baseline observation period, investigators will assess the patient’s daily seizure frequency. Patients who continue to meet the eligibility criteria will be randomized and will then begin receiving the investigational product (IP). Prior to receiving the IP on Day 1, patients will complete various questionnaires (SGIC-SD or CGIC-SD, CBCL or ABCL, SCQ, QOLCE or QOLIE-31-P, CGIC or SGIC, PGIC). The cannabidiol oral solution will be taken by patients for a period of 112 days. Clinic visits will occur on Days 28, 56, 84, 112, and Day 123, with a follow-up telephone visit on Day 151. During these visits, assessments will include concomitant medications, epilepsy-related hospitalizations, physical examinations, vital signs, ECG, and laboratory tests (hematology, biochemistry, urinalysis, UPT). Additionally, the same questionnaires will be administered at various points in the study.Any adverse events (AEs) observed during the study, regardless of whether they are attributed to the investigational product, will be documented in the Case Report Form (CRF). All AEs, whether identified by the investigator or reported by the patient, will be recorded, and further patient questioning will be conducted as necessary to gather additional information. |