NCT05983588View on ClinicalTrials.gov

PROFIL Study to Investigate the Effect of GPB on NfL Levels in Patients With Corticobasal Syndrome (CBS)

PHASE2RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 12, 2023

Primary Completion Date

March 30, 2026

Study Completion Date

March 30, 2026

Conditions
Corticobasal Syndrome (CBS)
Interventions
DRUG

RAVICTI 1.1 g/ml

"Duration of Treatment: 26 weeks, twice daily~Dosage:~* weeks 0 - 3: 3 ml/day (1,5ml - 0 - 1,5ml) (≙ 3,3 g glycerol phenylbutyrate/placebo)~* weeks 4 - 26: 6 ml/day (3 ml - 0 - 3 ml) (≙ 6,6 g glycerol phenylbutyrate/placebo)"

DRUG

Placebo

"Duration of Treatment: 26 weeks, twice daily~Dosage:~* weeks 0 - 3: 3 ml/day (1,5ml - 0 - 1,5ml) (≙ 3,3 g glycerol phenylbutyrate/placebo)~* weeks 4 - 26: 6 ml/day (3 ml - 0 - 3 ml) (≙ 6,6 g glycerol phenylbutyrate/placebo)"

Trial Locations (2)

81377

RECRUITING

Klinikum der Universität München (KUM), Campus Großhadern, Klinik und Poliklinik für Neurologie & German Center for Neurodegenerative Diseases (DZNE), Department of Neurology, Munich

RECRUITING

Klinikum rechts der Isar Technische Universität München Klinik und Poliklinik für Neurologie & German Center for Neurodegenerative Diseases (DZNE), Department of Neurology, Munich

All Listed Sponsors
lead

Technical University of Munich

OTHER