Safety Study of TPI-287 to Treat CBS and PSP (NCT02133846) | Clinical Trial Compass
CompletedPhase 1
Safety Study of TPI-287 to Treat CBS and PSP
United States44 participantsStarted 2014-05
Plain-language summary
The purpose of this study is to determine the safety and tolerability \[maximum tolerated dose (MTD) within planned dosing range\] of intravenous (IV) infusions of TPI 287 administered once every 3 weeks for 9 weeks (for a total of 4 infusions) in patients with primary four repeat tauopathies (4RT), corticobasal syndrome (CBS; also called corticobasal degeneration, CBD) or progressive supranuclear palsy (PSP).
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion criteria
✓. Between 50 and 85 years of age (inclusive);
✓. Able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker);
✓. MRI at Screening is consistent with CBS or PSP (≤ 4 microhemorrhages, and no large strokes or severe white matter disease);
✓. MMSE at Screening is between 14 and 30 (inclusive);
Exclusion criteria
✕. FDA-approved Parkinson's medications are allowed as long as the dose is stable for 2 months prior to Screening;
✕. Has a reliable study partner who agrees to accompany the subject to visits, and spends at least 5 hours per week with the subject;
✕. Agrees to 2 lumbar punctures;
✕. Signed and dated written informed consent obtained from the subject and the subject's caregiver in accordance with local IRB regulations;
✕0. 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.
✕1. Meets National Institute of Neurological Disorders and Stroke - Society for Progressive Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria (Litvan et al. 1996a), as modified for the Neuroprotection and Natural History in Parkinson Plus Syndromes (NNIPPS) clinical trial (Bensimon et al. 2009).
✕. Meets National Institute on Aging-Alzheimer's Association Workgroups criteria for probable AD (McKhann et al. 2011);
What they're measuring
1
Maximum tolerated dose of TPI-287 in patients with primary 4RT; CBS or PSP.
Timeframe: 21 months (first subject enrolled to last subject completed)