計劃書編號A0081046
試驗已結束
2006-06-01 - 2008-12-31
Phase I
終止收納4
一項隨機、雙盲、平行、比較性、多中心，以評估pregabalin(Lyrica)及lamotrigine(Lamictal)對於新診斷出局部發作的癲癇病患做為單一治療之臨床試驗。
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試驗委託 / 贊助單位名稱
輝瑞大藥廠股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 終止收納
實際收案人數
0 終止收納
適應症
Monotherapy treatment in patients with newly diagnosed partial seizures
試驗目的
主要目的:評估pregabalin相較於lamotrigine，做為新診斷為局部發作之癲癇病患單一治療，一天兩次服用之療效。
次要目的:評估pregabalin相較於lamotrigine做為單一治療之安全性與病患耐受性。
藥品名稱
膠囊劑
主成份
Pregabalin
劑型
130
劑量
75mg/150mg
評估指標
Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase
主要納入條件
Inclusion Criteria:
Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.
Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.
主要排除條件
Exclusion Criteria:
Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin.
Primary generalized seizures.
Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin.
Primary generalized seizures.
試驗計畫預計收納受試者人數
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台灣人數
30 人
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全球人數
788 人
