Cerevel reports results from the TEMPO-3, a P-III study (n= 507; 40-80yrs.), evaluating the efficacy, safety, and tolerability of tavapadon as an adjunctive therapy levodopa (LD) (titrated to 5-15mg) in adult patients, vs PBO and LD, orally and QD
Study (>27wks.) met 1EP, showing an increase of 1.1 hours in total “on” time from baseline without affecting dyskinesia vs LD + PBO (1.7 hrs. vs 0.6 hrs., p<0.0001); also met key 2EP, a substantial reduction in “off” time from baseline (MDS-UPDRS Part I, II, and III scores)
Furthermore, Cerevel is conducting a fourth OLE study (TEMPO-4) to assess the long-term safety and tolerability of tavapadon and results from P-III monotx. (TEMPO-1 & TEMPO-2) study is expected in H2`24
Ref: Cerevel | Image: Cerevel
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