An explorative use open-label, multi-center, randomized trial studying the safety and efficacy of levetiracetam (500 mg/day to 3000 mg/day) and valproate (600 mg/day to 3000 mg/day) as monotherapy in newly diagnosed patients over the age of 65 years. - Scandinavian elderly study

Birthe Pedersen0 个研究点目标入组 200 人开始时间: 2005年2月16日最近更新: 2012年3月19日

试验速览

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••Newly diagnosis of epilepsy (all types of seizures may be included) was made during the past year
•Age: 65 years and above.
•Patient must have had at least two unprovoked seizures with more than 24 hours interval in the past year and at least one seizure during the last 6 months.
•Patients with a known cerebral vascular events and having had the first seizure more than two weeks after the infarction was diagnosed.
•Must be considered as reliable and capable of adhering to the protocol.
•Written informed consent signed and dated by the patient or legally acceptable representative(s).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

••Expected life span less than 12 months.
•Previous AED treatment, i.e.:
•o Patients ever treated (any indication) with LEV or VPA in the past;
•o However, acute and subacute seizure treatment with drugs other than LEV or VPA is accepted with a maximum of 2 weeks duration, and if treatment was stopped at least 1 week before V1.
•oHowever, acute seizure treatment with VPA iv is accepted with a maximum of 2 weeks duration, and if treatment was stopped at least 4 week before V1.
•Presence of known pseudoseizures within the last year.
•History of convulsive status epilepticus
•Known hematological parameters: absolute neutrophil counts < 1,800/mm3 and/or platelet counts < 100,000/mm3.
•Presence or history of allergy to the components of levetiracetam tablets (lactose, cornstarch, and excipients) or other pyrrolidine derivatives and valproate.
•Presence of major psychiatric illness unless the patient is on appropriate therapy
•Participation in another clinical trial with an investigational drug

发起方

Birthe Pedersen