Efficacy of prophylactic levetiracetam for improving functional outcome in the acute phase of intracerebral haemorrhage: a randomised, double-blind, placebo-controlled, phase 3 trial PEACH 2
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 580
- 试验地点
- 15
- 主要终点
- Functional status (death or dependency) at 6 months will be measured by the modified Rankin Scale (mRS), using ordinal logistic regression, adjusted for the stratification criterion. The mRS score will be measured during a face-to-face or remotely (if needed because of patients’ clinical status) with a standardised guided interview by a certified stroke neurologist or a certified clinical research associate (only remotely) at the 6 month-follow up visit, blinded to the patient study group.
研究概览
简要总结
to establish if primary prophylactic antiseizure drug improves functional outcome at 6 months in patients with ICH.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Spontaneous (non-traumatic) supratentorial intracerebral haemorrhage diagnosed by brain CT or MRI
- •Onset of neurologic symptoms within 24 hours
- •NIHSS score on admission ≤ 25
- •Informed consent given by the patient or his/her impartial witness
- •Patients benefiting from a social insurance system or a similar system
排除标准
- •Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or cerebral tumour
- •Patients with inaugural seizures at the onset of symptoms associated with intracerebral hemorrhage
- •Patients with QTc prolongation
- •Patients who have been part of a clinical study involving another investigational product in the previous 30 days or within 5 half-lives of the other investigational product prior to Screening, whichever is longer, or participant is currently receiving an investigational product
- •Patients taking probenecid, methotrexate or macrogol
- •Current use of antiseizure drugs or history of epilepsy
- •Severe renal insufficiency (creatinine clearance < 30 ml/min)
- •Pregnancy or breastfeeding
- •Previous history of severe depression, or psychotic disorder or suicidal attempt
- •Known terminal illness
- •Known allergy or hypersensitivity to Levetiracetam or other pyrrolidone derivatives, or any of the excipients.
- •Known allergy or hypersensitivity to microcrystalline cellulose or lactose
- •Being under legal protection
研究组 & 干预措施
Keppra 250 mg film-coated tablets
干预措施: Keppra 250 mg film-coated tablets (Drug)
Keppra 100 mg/ml concentrate for solution for infusion
干预措施: Keppra 100 mg/ml concentrate for solution for infusion (Drug)
lEVETIRACETAM 100MG/ML
干预措施: lEVETIRACETAM 100MG/ML (Drug)
Lévétiracetam 125mg PLACEBO
干预措施: Lévétiracetam 125mg PLACEBO (Drug)
结局指标
主要结局
Functional status (death or dependency) at 6 months will be measured by the modified Rankin Scale (mRS), using ordinal logistic regression, adjusted for the stratification criterion. The mRS score will be measured during a face-to-face or remotely (if needed because of patients’ clinical status) with a standardised guided interview by a certified stroke neurologist or a certified clinical research associate (only remotely) at the 6 month-follow up visit, blinded to the patient study group.
Functional status (death or dependency) at 6 months will be measured by the modified Rankin Scale (mRS), using ordinal logistic regression, adjusted for the stratification criterion. The mRS score will be measured during a face-to-face or remotely (if needed because of patients’ clinical status) with a standardised guided interview by a certified stroke neurologist or a certified clinical research associate (only remotely) at the 6 month-follow up visit, blinded to the patient study group.
次要结局
- number of clinical seizures within 72 h and at 1, 6 and 12 months
- change in National Institute of Health Stroke Scale (NIHSS, 11 items version) score between inclusion and 72 h and 6 months.
- cognitive impairment assessed by the Montreal Cognitive Assessment (MoCA) version 8.3 at 6 months.
- Cognitive complaint assessed by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3 at 6 months.
- Quality of life assessed by the EuroQol - 5D-5L (EQ-5D-5L) at 6 and 12 months.
- modified Rankin Scale (mRS) score at 12 months
- Change in intracerebral haemorrhage volume (cc) and mass effect (mm) defined as midline shift on control brain imaging at 72 hours
- Frequency of side effects related to treatment at 1 and 6 months
- Frequency of pneumonia at 1 month
- Frequency of delirium at 1 month
- - anxiety and depression evaluated with the Hospital Anxiety and Depression Scale (HADS) at one and 6 months.
- all-cause mortality at 1, 6 and 12 months
研究者
Dr Laurent DEREX
Scientific
Hospices Civils De Lyon