BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TES (NCT03658135) | Clinical Trial Compass
TerminatedPhase 1
BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TES
Stopped: BIIB092 program discontinued
United States22 participantsStarted 2018-09-12
Plain-language summary
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients with Four Different Primary Tauopathy Syndromes
Who can participate
Age range35 Years – 80 Years
SexALL
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Inclusion criteria
✓. Between 35 and 80 years of age (inclusive);
✓. Able to walk at least 10 steps with minimal assistance (stabilization of one arm or use of cane/walker);
✓. MRI at Screening is consistent with the underlying neurodegenerative disease of the respective diagnostic cohort (i.e., CBS, nfvPPA, sMAPT, or TES), with no large strokes or severe white matter disease;
✓. Mini Mental State Exam (MMSE) at Screening is between 20 and 30 (inclusive);
✓. Amyloid beta (Aβ) positron emission tomography (PET) scan (florbetapir or equivalent) at Screening is not consistent with underlying Alzheimer's disease (AD).
✓. The following medications are allowed, but must be stable for 2 months prior to
✕. Has a reliable study partner who agrees to accompany the participant to visits, and spends at least 5 hours per week with the participant;
✕. Agrees to 3 lumbar punctures;
✕0. Signed and dated written informed consent obtained from the participant and the participant's study partner in accordance with local IRB regulations;
✕1. Women of childbearing potential (WCBP) must agree to abstain from sex or use an adequate method of contraception for the duration of the Screening period, the study drug treatment period, and for 155 days after the last dose of study drug;
✕2. Males must agree to abstain from sex with WCBP or use an adequate method of contraception for the duration of the study drug treatment period and for 215 days after the last dose of study drug.
✕3. Meets 2013 consensus criteria for possible or probable corticobasal degeneration (CBD), CBS subtype (Armstrong et al. 2013).
✕4. Meets 2011 consensus criteria for nfvPPA (Gorno-Tempini et al. 2011). Patients meeting 2013 Armstrong criteria for CBS-nfvPPA or 2017 Movement Disorder Society (MDS) criteria for progressive supranuclear palsy and speech/language disorders (PSP-SL) (Höglinger et al. 2017) would be assigned to this cohort since both of these definitions were derived from the 2011 Gorno-Tempini criteria.
✕5. Has known frontotemporal lobar degeneration- (FTLD-) causative MAPT mutation confirmed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (Ghetti et al. 2015);