Table 1.
Summary of published findings related to the efficacy and safety of tavapadon for treatment of Parkinson’s disease.
| Authors | Study Population | Study Design | Key Efficacy Findings | Key Safety Findings |
|---|---|---|---|---|
| Sohur et al [50] | • 18 adult males and females with idiopathic PD | • Randomized, double-blind, placebo-controlled single ascending dose (0.75, 1.5, and 3.0 mg or 3.0, 6.0, and 9.0 mg) crossover study of acute tavapadon following levodopa washout | • 9.0 mg of tavapadon improved motor control for 1-12 hours after administration • MDS-UPDRS-III tavapadon vs. placebo: -11.13 ± 3.68 (95% CI, -17.21 to -5.06) |
• Tavapadon was safe and well tolerated |
| • 50 adult males and females with idiopathic PD | • Randomized, open-label multiple ascending-dose studies of once-daily tavapadon (titrated to 5, 15, or 25 mg) over 21 days | • Once-daily 15 or 25 mg tavapadon led to sustained reductions in MDS-UPDRS-III scores on day 22 • 44% of patients treated with 5 mg, 78% of patients treated with 15 mg, and 50% of patients treated with 25 mg tavapadon experienced >10 levodopa-free days |
• 172 all-causality AEs were reported; most AEs were mild or moderate in severity • 6 AEs were severe • AEs led to study discontinuation in 11 patients |
|
| Reisenberg et al [52] | • Adult males and females with a clinical diagnosis of Parkinson’s disease (Hoehn & Yahr Stage I-III), MDS-UPDRS-III score ≥10 • Patients were treatment naïve or had <28 days of treatment with dopaminergic agents prior to the study |
• Randomized, double-blind, placebo-controlled, flexible-dose study of once-daily tavapadon over 15 weeks (9-week dose optimization phase and 6-week dose maintenance phase) |
• Patients receiving tavapadon reported an improvement over placebo of 4.8 ± 2.26 (90% CI, 1.0, 8.6) in MDS-UPDRS-III scores after 15 weeks • Improvements were also observed relative to the placebo at all time points prior to week 15 |
• 25 patients receiving tavapadon and 18 patients receiving the placebo reported TEAEs • 1 AE was severe • 2 patients in the tavapadon group and 4 patients in the placebo group discontinued the study due to AEs • More patients in the tavapadon group reported reductions in blood pressure that did not result in hypotension-related AEs (e.g. dizziness) |
Note: aPercentage of maintenance dose of levodopa. Abbreviations: AE, adverse event; LID, levodopa-induced dyskinesia; MDS-UPDRS-III, Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part III; PD, Parkinson’s disease; QTcF, QT interval corrected for heart rate by Fredericia’s formula; TEAE, treatment-emergent adverse event.