Condition: Primary Biliary Cholangitis (PBC) · Sponsor: Umecrine Cognition AB
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone compared with placebo among subjects with a history of non-cirrhotic or Child-Pugh class A cirrhotic Primary Biliary Cholangitis (PBC) with clinically significant fatigue and cognitive symptoms on stable background standard of care (SoC) PBC medication. The objectives of this research study are to assess the safety and tolerability as well the pharmacokinetic (PK) characteristics of golexanolone administered 40 mg BID for 5 days in the target population (part A) and to assess the safety and tolerability, the effects of golexanolone on health-related quality of life (HRQoL), including fatigue, day-time sleepiness and cognitive function as well as Investigator's overall impression of treatment effect of 28 days twice per day (BID) treatment with two dose levels of golexanolone versus placebo (part B).
This description comes directly from the study's public registry record.
Pernilla Sandwall · +46 70 630 65 19 · pernilla.sandwall@umecrine.se
Always discuss trial participation with your own doctor first.
| University Hospital Düsseldorf | Düsseldorf, Germany | Recruiting |
| University of Leipzig | Leipzig, Germany | Recruiting |
| Hippokration General Hospital of Athens | Athens, Greece | Recruiting |
| University Hospital of Patras | Pátrai, Greece | Recruiting |
| Bekes County Central Hospital | Gyula, Hungary | Withdrawn |
| Facility of CRU Hungary Ltd. | Kistarcsa, Hungary | Completed |
| Università di Milano-Bicocca, S.C. ASST Grande Ospedale Metropolitano Niguarda, Dipartimento di Medicina e Chirurgia, Epatologia e Gastroenterologia | Milan, Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori, Autoimmune Liver Disease Centre, ERN-Rare Liver, Department of Medicine and Surgery, Division of Gastroenterology | Monza, Italy | Not Yet Recruiting |
| University of Padova, Department of Surgery, Oncology and Gastroenterology | Padova, Italy | Recruiting |
| University Hospital Paolo Giaccone, University of Palermo | Palermo, Italy | Recruiting |
| A. Gemelli Polyclinic, Sacro Cuore Catholic University | Roma, Italy | Recruiting |
| Humanitas University | Rozzano, Italy | Recruiting |
+ 28 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07304843