Status:
RECRUITING
PROFIL Study to Investigate the Effect of GPB on NfL Levels in Patients With Corticobasal Syndrome (CBS)
Lead Sponsor:
Technical University of Munich
Conditions:
Corticobasal Syndrome (CBS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Corticobasal syndrome (CBS) is a rapidly progressive neurodegenerative disorder with an average survival time of about 6-8 years after the first clinical manifestation. No potent symptomatic treatment...
Eligibility Criteria
Inclusion
- Age: ≥ 18 years
- "clinical possible" or "clinical probable" CBS (Armstrong et al., Neurol-ogy, 2013 80;496-503) and patients with Progressive Supranuclear Palsy-CBS according to Höglinger et al. (Mov Disord. 2017 Jun;32(6):853-864)
- No regular consumption of glycerol phenylbutyrate within the last 6 months prior to V1
- Capable of thoroughly understanding all information given and giving full informed consent according to GCP
- Capability and willingness to comply with the procedures of the clinical trial
- Women of childbearing age must be non-lactating and surgically sterile or using a highly effective method of birth control and have a nega-tive pregnancy test. In case of using a hormonal contraception, the method must be supplemented with a barrier method (preferably male condom). Acceptable methods of birth control with a low failure rate i.e. less than 1% per year when used consistently and correct are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence (defined as refraining from heterosexual intercourse during the clinical trial) or vasectomized partner. Unacceptable birth control methods are: periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only and lactational amenorrhoea method (LAM). Female condom and male condom should not be used together.
- A stable regimen for at least 1 month prior to V1 and no foreseeable need to change the regimen throughout the 26 week treatment period for
- drugs acting against Parkinsonism (e.g. Levodopa, Dopamine-Agonists, Amantadine and MAO-B-Inhibitors)
- other CNS-active substances including e.g. antidepressants and antidementia drugs
Exclusion
- Neurodegenerative diseases other than CBS
- Underlying Alzheimer's pathology as defined by positive β-amyloid-PET or reduced Aβ 1-42 in CSF
- Participation in another clinical trial involving administration of an investigational medicinal product within 1 month or 5 half-lives of the investigational medicinal product, whichever is longer, prior to V1
- Known hypersensitivity to glycerol phenylbutyrate or its further components, or to drugs with a similar chemical structure or to any of the components of the placebo
- Treatment with valproic acid, haloperidol or probenecid
- A physical or psychiatric condition (e.g. frontal lobe syndrome, psychotic disorder or major depression), which at the investigator's discretion may put the subject at risk, may confound the trial results or may interfere with the subject's participation in this clinical trial
- Persistent abuse of medication, drugs or alcohol
- Current or planned pregnancy or breast-feeding in females
- Other severe medical conditions upon the discretion of the investigator
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05983588
Start Date
December 12 2023
End Date
March 30 2026
Last Update
September 26 2025
Active Locations (2)
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1
Klinikum der Universität München (KUM), Campus Großhadern, Klinik und Poliklinik für Neurologie & German Center for Neurodegenerative Diseases (DZNE), Department of Neurology
Munich, Bavaria, Germany, 81377
2
Klinikum rechts der Isar Technische Universität München Klinik und Poliklinik für Neurologie & German Center for Neurodegenerative Diseases (DZNE), Department of Neurology
Munich, Bavaria, Germany, 81377