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3 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
golexanolone (GR3027) / Karolinska Development
2017-002127-16: A study in patients with idiopathic hypersomnia involving two parts. Part A is an an open-label study to assess safety, tolerability and pharmacokinetics of a single oral GR3027 dose in female patients. Part B is a randomized, double-blind, placebo-controlled crossover study to assess safety, tolerability, exposure and exploratory efficacy of multiple oral doses of GR3027 in male and female IH patients. GR3027-valmisteen käyttöä tutkitaan liikaunisuuden hoidossa, jonka avoimessa osiossa arvioidaan suun kautta otettavan GR3027-kertaannoksen turvallisuutta, siedettävyyttä ja farmakokinetiikkaa naisilla ja jonka kaksoissokkoutetussa, lumekontrolloidussa tutkimusosiossa arvioidaan useasti suun kautta otettaviin GR3027-annoksiin liittyvää turvallisuutta, siedettävyyttä ja altistusta sekä tehokkuutta koskevia tietoja naisilla ja miehillä

Checkmark Safety, tolerability and PK data (Idiopathic hypersomnia)
Jan 2019 - Jan 2019: Safety, tolerability and PK data (Idiopathic hypersomnia)
Ongoing
2
20
Europe
GR3027, GR3027, Capsule
Umecrine Cognition AB, Umecrine Cognition AB
Idiopathic hypersomnia (IH), Idiopathic hypersomnia (IH), Diseases [C] - Nervous System Diseases [C10]
 
 
2016-003651-30: A double-blinded, randomized, placebo-controlled phase I/IIa study in healthy subjects and patients with liver cirrhosis evaluating safety, pharmacokinetics and preliminary effect of single and multiple doses of GR3027.

Ongoing
1/2
106
Europe
GR3027, GR3027, Capsule, hard
Umecrine Cognition AB, Umecrine Cognition AB
Hepatic encephalopathy (HE), Hepatic encephalopathy (HE) is a neuropsychiatric complication of either acute or chronic hepatic insufficiency (cirrhosis), Diseases [C] - Nervous System Diseases [C10]
 
 
2022-000422-16: A two-part study to investigate the effects in adults of two doses of a new drug called golexanolone in patients with primary biliary cholangitis with fatigue and cognitive dysfunction Kétrészes vizsgálat egy új, golexanolon nevű gyógyszer két dózisa hatásainak vizsgálatára kimerültséggel és kognitív diszfunkcióval járó primer biliáris cholangitisben szenvedő felnőtt betegek körében

Ongoing
1/2
101
Europe
Golexanolone, GR3027, Capsule, soft
Umecrine Cognition AB, Umecrine Cognition AB
Primary biliary cholangitis (PBC), Liver disease caused by autoimmune attack on the small to medium bile ducts, Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
 
 

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