Epilepsy
Conditions
Interventions
Added Dosage of Losartan
Sponsors
Cures Within Reach
Dalhousie University Department of Medical Neuroscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must be between the ages of 18 and 70 years and previously diagnosed with epilepsy. - Participants must have experienced seizures for at least the preceding 3 months despite prior and ongoing therapy with PB and/or CBZ. - Participants are to have at least one seizure per 28 days on average, with no seizure-free period longer than 28 days during the 3 months before enrolment, as well as during the 6-month baseline period. - Participants must have taken a therapeutic dosage regimen of PB or CBZ in the 3-months before enrolment and a stable therapeutic dosage during the 6-months baseline period.
Exclusion criteria
Exclusion criteria: - Female participants who are pregnant, breast-feeding, or of childbearing potential and not using approved methods of contraception. - Participants with a history of chronic alcohol or drug abuse. - Participants with any medical condition that might jeopardize the patient’s health or compromise the patient’s ability to participate in this trial including abnormal liver function; diastolic blood pressure 110 beats per minute after 3 minutes in a sitting position; history of severe anaphylactic reaction or serious blood dyscrasias; nonepileptic events, including psychogenic seizures; or any other clinically significant condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of losartan as an add-on treatment for patients with epilepsy. From the 6-month baseline to completion of the 6-month trial on losartan, the study’s clinical coordinator will be visited by participants at the Kakumbi Rural Health Centre to monitor (1) seizures’ semiology and frequency using a standard questionnaire filled monthly, and daily seizure diaries which will be completed by the patients or their caregivers; (2) blood pressure will be measured weekly during the first month of treatment with losartan and monthly for the five months thereafter; (3) quality of life and stigma will be measured using standard questionnaires filled before and after each 6-month monitoring period; and (4) side effects of ASMs and losartan will be monitored monthly using standard questionnaires and bloodwork. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effect of losartan on EEG features which are observed in patients with epilepsy. This would be completed by repeating EEG examinations (20-minute duration) upon recruitment, after 6 months baseline on phenobarbital and/or carbamazepine, and after 6 months’ add-on prescription of losartan. The EEG results will be read by an experienced epileptologist. Quantitative analysis for abnormal activity and interictal epileptiform activity will be done as established by our group.;Evaluate the effect of losartan on the drug levels of ASMs taken by the patients. Bloodwork will be taken w2eekly during the first month of treatment with losartan and monthly from months 2 to 6 with losartan as add-on treatment to evaluate and/or rule out its potential interactions with patients’ levels of phenobarbital and/or carbamazepine. The kidney and liver function, as well as hCG levels (for women at childbearing age), will also be measured. | — |
Countries
Zambia
Contacts
Public ContactAndrew Malunga
Nurse
Outcome results
None listed