An Open Label Study to Evaluate the Safety and Efficacy of FLX-787-ODT for Treatment of Fasciculations in the Tongue and One Appendicular Muscle in Adult Subjects With Amyotrophic Lateral Sclerosis (ALS)

The FLX-787-107 study will determine how well FLX-787-ODT works to reduce fasciculations in patients with Amyotrophic Lateral Sclerosis (ALS). The study will measure how often fasciculations occur, if tongue and muscle strength, speech, and swallowing are affected, and monitor any side effects that might develop while taking the investigational product. Participants will be assessed before and after taking a single dose of FLX-787-ODT. Approximately 15 people will take part in this study at one center in the United States. Participants will be in the study for a single clinic visit and receive a telephone call 7 days later to monitor for side effects.

开始日期2018-04-05

申办/合作机构

Flex Pharma, Inc.

NCT03338114 / Withdrawn临床1/2期

An Open Label Study to Evaluate the Safety and Efficacy of FLX-787-ODT for Treatment of Fasciculations in the Tongue and Upper or Lower Extremity Muscles Most Affected in Subjects With Amyotrophic Lateral Sclerosis (ALS)

The FLX-787-106 study will determine how well FLX-787-ODT works to reduce fasciculations in patients with Amyotrophic Lateral Sclerosis (ALS). The study will measure how often fasciculations occur, and monitor any side effects that might develop while taking the investigational product. Participants will be assessed before and after taking a single dose of FLX-787-ODT. Approximately 15 people will take part in this study at one center in the United States. Participants will be in the study for a single clinic visit and receive a telephone call 7 days later to monitor for side effects.

开始日期2017-11-01

申办/合作机构

Flex Pharma, Inc.

NCT03254199 / Terminated临床2期

A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT for Treatment of Muscle Cramps in Adult Subjects With Charcot-Marie-Tooth Disease

The COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with Charcot-Marie-Tooth disease (CMT) experiencing muscle cramps. Participants will be asked to take two study products during the course of the study. One of these study products will be a placebo.
Approximately 120 participants in 20 study centers across the United States are expected to take part. Participants will be in the study for approximately 3 months and visit the study clinic 3 times.

开始日期2017-10-16

申办/合作机构

Flex Pharma, Inc.

100 项与 FLX-787 相关的临床结果

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100 项与 FLX-787 相关的转化医学

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100 项与 FLX-787 相关的专利（医药）

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项与 FLX-787 相关的新闻（医药）

2018-06-28

·GlobeNewswire

UPCOMING DEADLINES: The Klein Law Firm Reminds Investors of Class Actions on Behalf of Shareholders of NWL, MOH, and FLKS

NEW YORK, June 28, 2018 (GLOBE NEWSWIRE) -- The Klein Law Firm announces that class action complaints have been filed on behalf of shareholders of the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. Newell Brands Inc. (NYSE:NWL) Lead Plaintiff Deadline: August 20, 2018 Class Period: February 6, 2017 - January 24, 2018 Allegations: The Company’s retail channel was loaded with extremely high levels of unsold Newell product; contrary to defendants’ representations, the build-up of Newell inventory in the retail channel was due to Company-specific rather than macroeconomic reasons; as a result of the unusually high levels of unsold inventory in the retail channel, Newell was exposed to a heightened risk that it would experience slower sales growth in future periods; and undisclosed managerial and cultural differences in the legacy Newell and Jarden businesses had created significant discord that was having a material adverse effect on the Company’s operating performance. Get additional information: http://www.kleinstocklaw.com/pslra-c/newell-brands-inc?wire=3. Molina Healthcare, Inc. (NYSE:MOH) Lead Plaintiff Deadline: June 29, 2018 Class Period: October 31, 2014 - August 2, 2017 Allegations: Molina Healthcare made materially false and/or misleading statements or failed to disclose that: Molina's administrative infrastructure was never designed to handle the size and complexity of its rapid growth strategy; and (2) it failed to remediate systemic issues and costly disruptions with critical administrative infrastructure functions, including provider payment and utilization management. Get additional information: http://www.kleinstocklaw.com/pslra-c/molina-healthcare-inc-2?wire=3. Flex Pharma, Inc. (NASDAQ:FLKS) Lead Plaintiff Deadline: August 20, 2018 Class Period: November 6, 2017 - June 12, 2018 Allegations: The Company overstated the viability and approval prospects for its product candidate FLX-787 for the treatment of amyotrophic lateral sclerosis and Charcot-Marie-Tooth disease; and as a result, Flex Pharma's public statements were materially false and misleading at all relevant times. Get additional information: http://www.kleinstocklaw.com/pslra-c/flex-pharma-inc?wire=3. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff. There is no cost or obligation to you. If you suffered a loss during the class period and wish to obtain additional information, please contact Joseph Klein, Esq. by telephone at 212-616-4899 or visit the webpages provided. Joseph Klein, Esq. represents investors and participates in securities litigations involving financial fraud throughout the nation. Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT:Joseph Klein, Esq.Empire State Building350 Fifth Avenue59th FloorNew York, NY 10118jk@kleinstocklaw.comTelephone: (212) 616-4899Fax: (347) 558-9665www.kleinstocklaw.com

100 项与 FLX-787 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肌束颤动	临床2期	美国	Flex Pharma, Inc.	2017-11-01
腓骨肌萎缩症	临床2期	美国	Flex Pharma, Inc.	2017-10-16
运动神经元疾病	临床2期	美国	Flex Pharma, Inc.	2017-07-28
肌痛性痉挛	临床2期	美国	Flex Pharma, Inc.	2017-07-28
肌萎缩侧索硬化	临床2期	澳大利亚	Flex Pharma, Inc.	-
多发性硬化症	临床2期	-	Flex Ltd.	-
多发性硬化症	临床2期	-	Flex Ltd.	-

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Flex-201 (ECTRIMS2018)	临床2期	多发性硬化症	57	FLX-787	鹽蓋窪廠壓艱網蓋顧願(餘餘膚壓蓋鹽鑰憲淵餘) = 憲顧範憲顧遞簾選膚網鬱醖襯鏇膚壓膚鬱觸夢 (構襯膚鹽選憲顧廠鑰糧, p=0.0427) 更多	积极	2018-10-09