2026-525896-23-00招募中2 期
A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Potential Antiseizure Activity of Adjunctive OV329 Therapy in Adults with Drug-Resistant Focal Epilepsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence, severity, and temporal profile of treatment-emergent AEs (TEAEs).
研究概览
简要总结
To assess the safety and tolerability of adjunctive OV329 compared to placebo in drug-resistant focal epilepsy patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must give written informed consent after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.
- •A 12-lead ECG, obtained at screening and baseline must show no clinically significant abnormalities, as deemed by the investigator, with a Corrected QT interval by Fridericia’s formula (QTcF) interval ≤450 milliseconds for males and ≤470 milliseconds for females. Participants with ECG findings that are abnormal but not clinically significant may be enrolled at the discretion of the investigator, provided the decision is documented by the investigator’s signature.
- •Resting supine pulse rate between 45 and 100 beats per minute at screening and baseline.
- •Based on the current guidance, only symptomatic individuals should be tested for COVID-
- •Positive COVID-19 results at screening or baseline are only exclusionary for the entire 28-day screening period if the participant has a repeat COVID-19 PCR test that is positive ≥ 14 days following the date of the initial screening or baseline positive test. If that is the case, the participant would be considered a screen failure and would be eligible for rescreening once negative results are obtained. If the repeat COVID-19 PCR test result is negative 14 days or more from the date of the positive test, the participant can be enrolled if the participant is still within the 28-day screening window. COVID-19 testing is considered optional for this study. Requirements for testing are in accordance with policies and procedures of the site/institution.
- •Willing to abstain from illicit drugs and alcohol use during study participation.
- •Female participants of childbearing potential (defined as first menarche through post-menopause or permanent sterilization) must agree to use a highly effective method of birth control from time of screening until 1 month following the last dose of study drug. Highly effective contraceptive methods are as follows and must be in use for at least 90 consecutive days before drug administration: a. Intrauterine device b. Intrauterine hormone-releasing system c. Bilateral tubal occlusion d. Intravaginal or transdermal hormonal contraception e. Injectable or implantable contraceptive systems, including progestogen-only hormonal contraception associated with inhibition of ovulation f. Vasectomized or same sex partner g. Abstinence (see note below) NOTE: The double barrier method is not considered highly effective per Clinical Trials Facilitation and Coordination Group contraceptive guidance. Oral contraceptives alone (without a highly effective contraceptive listed above) are not permissible. Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of this clinical trial and the preferred and usual lifestyle of the participant.
- •Male participants (post-pubertal), unless permanently sterilized by bilateral orchidectomy or vasectomy, must agree to use male contraception (condom) and/or abstinence from time of screening through the end of the study.
- •Male and female participants aged 18 to 65 years of age, inclusive, at the time of informed consent.
- •Have a diagnosis of drug-resistant focal epilepsy for ≥2 years. Drug-resistant focal epilepsy should be diagnosed in accordance with ILAE consensus criteria. In addition, participants must have a documented history of failure of at least 3 adequately tried, tolerated and appropriately chosen ASMs. This may include ASMs that were previously discontinued as well as ASMs that are currently being taken but have not adequately controlled seizures. The diagnosis must be confirmed by secondary review and supported by clinical history, electroencephalogram (EEG), and/or video EEG findings consistent with focal epilepsy. Brain imaging (computerized tomography [CT] or magnetic resonance imaging [MRI]) must have been performed within the last 10 years to exclude progressive structural lesions.
- •Have an adequately documented history of focal seizures such that the investigator judges that the participant is likely to have FPC-O, FIC, and/or FBTC seizures at a frequency of ≥4 countable seizures per 28 days during the 8 week historical period immediately prior to screening and during the 4-week prospective baseline period, as documented in the seizure diary. Participants must not have ≥21 consecutive countable focal seizure-free days during the 4-week prospective baseline period. Participants who experience only focal seizures with preserved-consciousness without observable manifestations (FPC) are not eligible for participation. However, participants who experience FPC seizures in addition to FPC-O seizures are eligible. Adequate historical seizure documentation must include seizure type(s), seizure frequency, dates of seizure occurrence, and dates on which no seizures occurred. Participants without adequate historical seizure documentation must complete 8 weeks of prospective baseline seizure diary recording in place of the standard 4-week prospective baseline period.
- •Currently receiving stable antiseizure therapy, defined as treatment with 1-3 concomitant ASMs with or without nonpharmacologic anti-seizure therapy (e.g., VNS, RNS, or ketogenic diet) for ≥1 month prior to the Screening visit, no anticipated changes in therapy or dosing during the 12-week DB treatment period. a. Barbiturates: if the participant is receiving barbiturates (e.g., phenobarbital), the barbiturate dose must have been stable for ≥1 month prior to the Screening visit / b. VNS or RNS will not be counted towards the number of concomitant ASMs. Participants with surgically implanted VNS or RNS may be enrolled provided all of the following conditions are met: i. The VNS or RNS has been in place for ≥ 1 year prior to the screening visit / ii. The settings must have remained constant for ≥3 months prior to the screening visit and is expected to remain constant throughout the 12-week double-blind maintenance period / iii.The battery is expected to last for the duration of the 12-week DB maintenance period / c. The ketogenic diet will not count toward the number of concomitant ASMs and must be stable for ≥1 month prior to screening with no anticipated changes during the 12-week DB maintenance period. / d. Benzodiazepines: The chronic use of benzodiazepine as a concomitant ASM is permitted as long as the dose has been stable for ≥1 month prior to the screening visit and remains constant throughout the 12-week DB maintenance period. Intermittent benzodiazepine for seizure rescue or for other indications (i.e., 1 to 2 doses over 24 hours) is permissible. It will not count as one of the ASMs, however, use on more than one occasion within a 28-day period will need to be reviewed as a concomitant ASM and/or the investigator will determine and document the benefit to the patient for remaining in the trial. / e. Felbamate: the use of felbamate is allowed provided that the participant has been maintained on a stable dose of felbamate for ≥18 months and has had stable liver function (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) and hematology during the course of the treatment and is expected to remain constant throughout the study.
- •Able and willing to maintain an accurate and complete daily seizure diary for the duration of the study.
- •Must be willing and able to comply with study procedures (including diet) and visit schedules and be able to understand and follow verbal and written instructions.
- •Weighs at least 50 kg and has a body mass index ≥18.0 and ˂40.0 kg/m2 at Screening.
- •Resting supine systolic blood pressure 90 to 145 mmHg (inclusive) and diastolic blood pressure no higher than 90 mmHg at screening and baseline.
排除标准
- •Have previous exposure to OV
- •History or presence of gastritis, gastrointestinal tract or gastric bypass surgery, hepatic disorder, or other clinical condition which, in the opinion of the investigator or designee, may affect the absorption, distribution, metabolism, or elimination of the study drug. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks prior to first dosing.
- •History or presence of drug abuse within the past 2 years prior to screening visit.
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- •Use of dietary supplements or herbal preparations are not permitted if the participant has been using them consistently for <6 months prior to screening or does not plan on remaining on stable doses for the duration of the 12-week DB maintenance period.
- •A history of chronic noncompliance with drug regimens.
- •Plans to have any surgery during the screening, maintenance, taper or follow-up periods.
- •Risk of suicide according to the investigator’s clinical judgment (e.g., per the C-SSRS) or has made a suicide attempt in the previous 2 years prior to the screening visit. Participants should be excluded if the participant has had suicidal intent (C-SSRS ideation items 4 or 5) in the last 12 months.
- •Pregnant or breastfeeding an infant.
- •Exposure to any investigational drug or investigational medical device ≤30 days prior to screening, or planned exposure to any investigational drug or device at any time during the study.
- •Time of onset of epilepsy treatment <2 years prior to screening.
- •Have generalized or combined focal epilepsy, such as Lennox Gastaut syndrome, juvenile myoclonic epilepsy, absence epilepsy, or non-epileptic seizures within the last 12 months prior to screening.
- •Have <4 countable focal seizures (either FPC-O, FIC, or FBTC) in a 28-day period and/or have ≥21 consecutive seizure-free days during the prospective baseline period.
- •Current use of vigabatrin is not permitted, as well as prior use of vigabatrin unless the participant has stable visual fields tested twice over the 12 months from the last dose of vigabatrin.
- •Abnormal clinical laboratory test results at Screening (Visit 1) that suggest a clinically significant underlying disease that would compromise the well-being of the participant. Specific exclusions: Abnormalities in ALT, AST, gamma-glutamyl transferase, or alkaline phosphatase are exclusionary at Screening and Baseline if >2.5 × upper limit of normal (ULN) and/or if total bilirubin is >2 × ULN or international normalized ratio is >1.5, unless an alternative non-hepatic etiology is clearly documented and approved by the medical monitor.
- •Uncontrolled diabetes mellitus (HgA1c>7%), history of alcohol abuse within the 2 years prior to screening; or active (untreated or clinically significant) vitamin B12 or copper deficiency
- •History of cardiovascular or cerebrovascular disease, stroke or other uncontrolled serious medical illness, myocardial infarction within 6 months of screening, congestive heart failure, history of long QT syndrome, a long QTcF (>450 milliseconds for male or >470 milliseconds for female), or clinically significant laboratory abnormalities.
研究组 & 干预措施
Placebo is identical to the IMP but with no active substance.
Placebo
干预措施: Placebo is identical to the IMP but with no active substance. (Drug)
OV329, OV329
Test
干预措施: OV329 (Drug)
结局指标
主要结局
Incidence, severity, and temporal profile of treatment-emergent AEs (TEAEs).
Incidence, severity, and temporal profile of treatment-emergent AEs (TEAEs).
Incidence of clinically significant abnormalities in vital signs, 12-lead ECGs, clinical laboratory test results, and physical examinations.
Incidence of clinically significant abnormalities in vital signs, 12-lead ECGs, clinical laboratory test results, and physical examinations.
Incidence of treatment-emergent suicidal ideation and/or suicidal behavior as assessed by the C-SSRS.
Incidence of treatment-emergent suicidal ideation and/or suicidal behavior as assessed by the C-SSRS.
次要结局
未报告次要终点
研究者
Julia Tsai
Scientific
Ovid Therapeutics Inc.
研究点 (1)
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