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Nervous System Diseases

Congenital Disorders

Other Diseases

Small molecule drug

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Disease Domain	Count

Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

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Sodium channels	1

Primary objective: To evaluate the long-term safety and tolerability of lacosamide in pediatric subjects. Secondary objective: To evaluate the efficacy of lacosamide during long-term exposure in pediatric subjects. Other objectives: To evaluate the behavior, cognition, quality of life, and development of pediatric subjects during long-term lacosamide exposure.

Start Date19 Oct 2018

Sponsor / Collaborator

Aesica Pharmaceuticals GmbH

[+2]

CTR20160914 / CompletedPhase 3

一项多中心开放长期扩展研究评价拉考沙胺作为联合疗法用于治疗儿童部分性发作癫痫受试者的有效性和安全性

[Translation] A multicenter, open-label, long-term extension study evaluating the efficacy and safety of lacosamide as combination therapy in the treatment of pediatric subjects with partial-onset epilepsy

主要目的：评估拉考沙胺在儿童受试者中的长期安全性和耐受性。次要目的：评估拉考沙胺在儿童受试者长期暴露期间的有效性。其他目的：评估儿童受试者在长期拉考沙胺暴露期间的行为、认知、生活质量和发育。

[Translation]

Primary objective: To evaluate the long-term safety and tolerability of lacosamide in pediatric subjects. Secondary objective: To evaluate the efficacy of lacosamide during long-term exposure in pediatric subjects. Other objectives: To evaluate the behavior, cognition, quality of life, and development of pediatric subjects during long-term lacosamide exposure.

Start Date19 Oct 2018

Sponsor / Collaborator

Aesica Pharmaceuticals GmbH

[+3]

CTR20160916 / CompletedPhase 3

多中心双盲随机安慰剂对照评价拉考沙胺作为联合疗法用于治疗1个月至4岁的部分性发作癫痫的有效性和安全性

[Translation] A multicenter, double-blind, randomized, placebo-controlled evaluation of the efficacy and safety of lacosamide as a combination therapy for the treatment of partial-onset epilepsy in children aged 1 month to 4 years

本研究的主要目的在于评价拉考沙胺与1~3种抗癫痫药物（AED）合并给药治疗目前患有未控制的部分性发作癫痫的受试者（1个月≤年龄＜4岁）的有效性。次要目的为评价拉考沙胺治疗目前患有未控制的部分性发作癫痫的受试者（1个月≤年龄＜4岁）的安全性和耐受性。其他目的为评价拉考沙胺在1个月≤年龄＜4岁的儿童中的药代动力学（PK）。

[Translation]

The primary objective of this study was to evaluate the efficacy of lacosamide in combination with 1 to 3 antiepileptic drugs (AEDs) in subjects (1 month ≤ age < 4 years) currently suffering from uncontrolled partial-onset epilepsy. The secondary objective was to evaluate the safety and tolerability of lacosamide in subjects (1 month ≤ age < 4 years) currently suffering from uncontrolled partial-onset epilepsy. Other objectives were to evaluate the pharmacokinetics (PK) of lacosamide in children 1 month ≤ age < 4 years.

Start Date03 Aug 2018

Sponsor / Collaborator

Aesica Pharmaceuticals GmbH

[+3]

100 Clinical Results associated with Aesica Pharmaceuticals GmbH

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0 Patents (Medical) associated with Aesica Pharmaceuticals GmbH

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100 Deals associated with Aesica Pharmaceuticals GmbH

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100 Translational Medicine associated with Aesica Pharmaceuticals GmbH

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Approved

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