The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
390
Change from Baseline in 28-day average seizure frequency
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 8-week double-blind treatment phase.
Time frame: Baseline, Week 8 to Week 16
Percentage of Participants with at at least 50% reduction in seizure frequency per month
To compare the efficacy of 2 dose strengths of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 8 week double-blind phase to the observation phase.
Time frame: Baseline, Week 8 to Week 16
Change from Baseline in 28-day average seizure frequency during first month of treatment
To compare the efficacy of BHV-7000 to placebo during the first month of treatment. This objective will be measured by the change in log-transformed 28-day adjusted seizure frequency from observation phase over the first month of the double blind phase.
Time frame: Baseline, Week 8 to Week 12
Percentage of Participants with at at least 75% reduction in seizure frequency per month
To compare the efficacy of BHV-7000 to placebo as measured by the proportion of subjects that have at least a 75% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the double-blind phase compared to the observation phase.
Time frame: Baseline, Week 8 to Week 16
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Accel Research
Birmingham, Alabama, United States
WITHDRAWNOnyx Clinical Trials
Peoria, Arizona, United States
NOT_YET_RECRUITINGXenoscience, Inc.
Phoenix, Arizona, United States
RECRUITINGUniversity of Arizona / Banner University Medical Center Phoenix
Phoenix, Arizona, United States
RECRUITINGARENSIA Exploratory Medicine
Phoenix, Arizona, United States
RECRUITINGClinical Trials, Inc.
Little Rock, Arkansas, United States
RECRUITINGAmicis Research Center
Lancaster, California, United States
WITHDRAWNMemorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California, United States
RECRUITINGTri Valley Neurology Medical Associates, Inc.
Mission Hills, California, United States
RECRUITINGStanford University
Palo Alto, California, United States
NOT_YET_RECRUITING...and 162 more locations
Percentage of Participants with seizure freedom during DB Phase
To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DBP phase). This objective will be measured by proportion of subjects that are seizure free during the double-blind phase.
Time frame: Week 8 to Week 16
Change from baseline in 7-day adjusted seizure frequency during first week of treatment
To compare the efficacy of BHV-7000 to placebo during the first week of treatment. This objective will be measured by the change in log-transformed 7-day adjusted seziure frequency from observation phase over the first week of the double-blind phase.
Time frame: Baseline, Week 8 to Week 9
Change from baseline in Patient Global Impression of Change (PGI-C)
To compare the efficacy of BHV-7000 to placebo on the patient global impression of change (PGI-C). This objective will be measured by proportion of subjects at week 8 of double-blind treatment phase with a PGI-C response of "minimally improved", "much improved" or "very much improved". This scale is a 7-point Likert scale with response options of: (1) "very much improved" , (2) "much improved", (3) "minimally improved", (4) "no change", (5) "minimally worse", (6) "much worse", (7) and "very much worse"
Time frame: Baseline, Week 16
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Time frame: Week 8 to Week 16
Number of Participants With Clinically Significant Laboratory Abnormalities
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
Time frame: Week 8 to Week 16