Health Condition 1: G408- Other epilepsy and recurrent seizures
Conditions
Interventions
Intervention1: cannabidiol 100 mg/ml oral
solution: Cannabidiol 100mg/ml
given orally for 112 days
Sponsors
Zenara pharma private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: Day-(-7), Day-1,Day-28, Day-56, Day-84, Day-112, Day-123, Day-151 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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).Timepoint: week-4, week-12, week-16 | — |
Countries
India
Contacts
Public ContactDr Swati katharia
Noble hospital and research centre
Outcome results
None listed