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This is a double-blind, placebo controlled, randomized study of dose-ranging safety, tolerability, exploratory efficacy of adjunctive EQU-001 for seizures using the continuous reassessment method in patients diagnosed with epilepsy.
Full description
EQU-201 is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate dose-ranging safety, tolerability, and exploratory efficacy of adjunctive EQU-001 using the continuous reassessment method (CRM). 10 participants diagnosed with epilepsy according to the International League Against Epilepsy (ILAE) Classification of the Epilepsies 2017 criteria whose seizures are uncontrolled on one to four concomitant antiepileptic drugs (AEDs) for ≥4 weeks will be enrolled in 4 dose cohorts (10 mg, 20 mg, 40 mg, 60 mg) The participants will be randomized 4:1, drug to placebo. The dosing is for 12 weeks, after which, safety data will be reviewed post 14 days to determine whether the next cohort can be opened. Once the 12-week study dosing period is complete, all subjects may enroll in an open-label extension, during which period investigators may make dose adjustments down to 20 mg and up 80 mg.
This study of EQU-001 will provide safety of a range of doses, tolerability, and PK data in patients with epilepsy and aims to identify drug-specific DLTs and MTD. The PK component will characterize the PK of EQU-001 to inform dosing and may help to correlate exposures with any DLTs or other treatment-related AEs. The open label extension component will provide data on subject safety, tolerability and efficacy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Able to provide informed consent, or consent provided by a Legally Authorized Representative (LAR)
Diagnosed with epilepsy according to ILAE 2017 criteria and with uncontrolled countable seizures (as per Epilepsy Study Consortium review) on one to four concomitant anti-seizure medicines (AEDs) at optimal stable dosages for at least 4 weeks prior to screening and throughout the treatment period
Age 18 to 60 years of age
Must have had a brain MRI or CT scan with an available report (images need not be available) that is negative for other confounding conditions
Must have an EEG report consistent with the subject's seizure type(s)
Pre-menopausal females and males with pre-menopausal sexual partners should either be sexually inactive (abstinent) for 21 days prior to the first dose, throughout the study, and for 14 days following the last dose or, if heterosexually active, agree to use of one of the following acceptable birth control methods for the period above:
Able and willing to adhere to protocol; the subject or selected observer can keep an accurate seizure diary
Before progressing from Baseline Period to Randomization:
A subject must experience at least 3 countable observable seizures per 4 weeks prior to randomization, including at least the 4-week baseline period.
These seizures may be generalized, focal, or of unknown onset, but may not include absence seizures or focal aware seizures without a detectable motor component, aphasia, or other observable symptom.
Exclusion criteria
Pregnant or lactating female
History of hypersensitivity to ivermectin
Ivermectin use within 28 days of screening
History of progressive neurological disorder or other significant progressive disorder or unstable medical condition(s)
Change in AED regimen in the 28 days prior to screening
Taking >4 concomitant AEDs at screening
History of status epilepticus in the 2 years prior to screening
A vagal nerve stimulator (VNS), responsive neurostimulator (RNS) or deep brain stimulator (DBS), implanted or activated <1 year prior to screening, or with stimulation parameters stable for <3 months or battery life of unit not anticipated to extend for the duration of the trial
History of traumatic brain injury within 28 days prior to screening
History of psychogenic non-epileptic seizures (PNES), active or within 2 years prior to study entry
Epilepsy-related surgery within 1 year prior to screening, epilepsy-related radiosurgery or laser surgery within 1 year prior to screening
Epilepsy dietary therapy initiated <3 months prior to screening
Psychiatric disorder in which changes in pharmacotherapy are needed or anticipated during the study
Active suicidal plan/intent in the 6 months prior to screening and evidenced by a positive response to C-SSRS questions 4 or 5, a history of suicide attempt in the 2 years prior to screening, or more than 1 lifetime suicide attempt.
Administration of investigational product in another trial within 28 days prior to the first expected study drug administration, or five half-lives, whichever is longer.
Receiving felbamate for <1 year prior to screening
Receiving vigabatrin for <2 years prior to screening. Subjects on vigabatrin should have available, appropriate documentation of visual fields
Receiving ezogabine (ex-US) at screening
Use of the following medications and foods at screening or baseline that may interfere with study drug:
Has any of the following laboratory abnormalities at screening:
Subject is not approved for study inclusion by the Epilepsy Consortium based on the diagnostic review form
Any condition that, in the opinion of the investigator, may impact a subject's safety or ability to follow study procedures.
Primary purpose
Allocation
Interventional model
Masking
43 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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