NL-OMON49353招募中不适用
A randomized, double-blind, two-way cross-over study to determine the effects of levetiracetam on corticospinal excitability in patients with treatment-controlled epilepsy, as measured by single and paired pulse TMS-EMG and TMS-EEG - TMS to assess drug effects in epilepsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed informed consent prior to any study-mandated procedure
- •2. Male or female subjects, 18 to 54 years of age, inclusive at screening, with
- •generalized epileptic seizures.
- •3. Study participant is currently treated for epilepsy with stable doses of the
- •following for at least 3 months:
- •a. Group 1: levetiracetam mono-therapy (1000 mg daily)
- •b. Group 2: valproic acid mono-therapy (up to and including 1000 mg daily)
- •4. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and
- •with a minimum weight of 50 kg.
- •5. All women of child bearing potential must practice effective contraception
- •during the study and be willing and able to continue contraception for at least
- •90 days after their last dose of study treatment.
- •6. Has the ability to communicate well with the Investigator in the Dutch
- •language and willing to comply with the study restrictions.
排除标准
- •1. Evidence of any active or chronic disease or condition, apart from epilepsy,
- •that could interfere with, or for which the treatment of might interfere with,
- •the conduct of the study, or that would pose an unacceptable risk to the
- •subject in the opinion of the investigator (following a detailed medical
- •history, physical examination, vital signs (systolic and diastolic blood
- •pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)).
- •Minor deviations from the normal range may be accepted, if judged by the
- •Investigator to have no clinical relevance.
- •2. Clinically significant abnormalities, as judged by the investigator, in
- •laboratory test results (including hepatic and renal panels, complete blood
- •count, chemistry panel and urinalysis). In the case of uncertain or
- •questionable results, tests performed during screening may be repeated before
- •randomization to confirm eligibility or judged to be clinically irrelevant for
- •healthy subjects.
- •3. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
- •or human immunodeficiency virus antibody (HIV Ab) at screening.
- •4. Abnormal findings in the resting ECG at screening defined as:
- •a. QTcF> 450 msec for males, or >470 for females; or < 300 msec
- •b. Evidence of atrial fibrillation, atrial flutter, complete branch block,
- •Wolf-Parkinson-White Syndrome, or cardiac pacemaker
- •5. Use of concomitant medications (prescription or over-the-counter [OTC]) that
- •could interfere with the study drug or the TMS measurements, within 14 days of
- •study drug administration, or less than 5 half-lives (whichever is longer), as
- •judged by the investigator. This does not include the permitted medication as
- •listed in chapter 4.4 of this protocol.
- •6. Participation in an investigational drug or device study within 3 months
- •prior to first dosing.
- •7. History of abuse of addictive substances (alcohol, illegal substances) or
- •current (within the last 6 months) use of more than 21 units alcohol per week,
- •drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any
- •other addictive agent
- •8. Positive test for drugs of abuse at screening or pre-dose.
- •9. Alcohol will not be allowed from at least 24 hours before screening or
- •10. Use of tobacco or nicotine products within 24 before the dose
- •administration.
- •11. A previous significant allergic reaction (urticaria or anaphylaxis) to
- •levetiracetam
- •12. Loss or donation of blood over 500 mL within three months (males) or four
- •months (females) prior to screening or intention to donate blood or blood
- •products during the study, or plasma donation within 2 weeks of screening.
- •13. If a woman, pregnant, or breast-feeding, or planning to become pregnant
- •during the study.
- •14. Any known factor, condition, or disease that might interfere with treatment
- •compliance, study conduct or interpretation of the results such as drug or
- •alcohol dependence or psychiatric disease.
- •15. The subject has a history of intracranial mass lesion, hydrocephalus and/or
- •clinically significant head injury or trauma that could increase the risk of
- •applying TMS
- •16. The subject has metal objects in brain or skull.
- •17. The subject has a cochlear implant or deep brain stimulation device.
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研究者
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