Status and phase
Conditions
Treatments
About
This is a multi-center, open label, pilot futility clinical trial of the safety, tolerability, pharmacodynamics and preliminary efficacy of oral salsalate in up to 10 patients with PSP.
Full description
This is a multi-center, open label, pilot futility clinical trial of the safety, tolerability, pharmacodynamics and preliminary efficacy of oral salsalate in up to 10 patients with PSP. All participants will be administered 2,250 mg daily [1,500 mg every day before noon (every AM) and 750 mg every night at bedtime (every HS)] for 6 months.
If ≥3 patients experience drug limiting toxicity (DLT), as defined below, the study will be terminated.
A DLT is defined as: 1) any Grade 3 or higher adverse event (AE) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) for which there is reasonable possibility that salsalate caused the event, 2) any Grade 2 AE in the CTCAE system organ class of nervous system disorders that is considered clinically significant and for which there is reasonable possibility that salsalate caused the event, or 3) any Grade 2 or higher treatment-related adverse events during administration that do not resolve promptly with supportive treatment.
An interim futility analysis will be performed after five subjects have completed 6 months of study drug treatment. If the criteria listed in the Statistical Methods section of this synopsis are met, an additional 5 subjects will be enrolled in the trial. If not, the trial will be terminated.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Meets National Institute of Neurological Disorders and Stroke - Society for Progressive Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria,(Litvan 1996a) as modified from the AL-108-231 trial.(Boxer 2014)
Aged 50-85
Agrees to 3 magnetic resonance imaging (MRI) or subject to investigator's discretion
MRI at screening is consistent with PSP (≤4 microhemorrhages and no large strokes or severe white matter disease)
Mini-Mental State Examination (MMSE) score 14-30
Stable medications for 2 months prior to screening, including FDA approved Alzheimer's disease (AD) medications and Parkinson's disease medications
Availability of a study partner who knows the patient well and is willing to accompany the patient to all trial visits and to participate in questionnaires
Agrees to 2 lumbar punctures for cerebrospinal fluid (CSF) examination
Signed and dated written informed consent obtained from the subject and subject's caregiver in accordance with local IRB regulations
Males and all WCBP agree to abstain from sex or use an adequate method of contraception for the duration of the study and for 30 days after the last dose of study drug.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal