Levodopa Initiation or Dose Adjustments in TEMPO-4: A 58-Week Open-label Trial of Tavapadon for Treatment of PD
William Ondo1, Meredith Hatcher2, Michael Soileau3, James Eubanks4, Tracy Nicholson4, Rohit Dhall5
1Houston Methodist Neurological Institute, Weill Cornell Medical School, 2Texas Movement Disorder Specialists, 3Texas Movement Disorder Specialists, PLLC, 4AbbVie, Inc., 5University of Arkansas for Medical Sciences
Objective:
To evaluate changes in levodopa use among adults with Parkinson’s disease (PD) receiving tavapadon in the TEMPO-4 trial (NCT04760769).
Background:
Tavapadon, an oral, once-daily, selective D1/D5 agonist, demonstrated improvements in PD symptoms with a favorable safety profile in phase 3 trials of early PD (TEMPO-1 [NCT04201093] and TEMPO-2 [NCT04223193]) and in PD with uncontrolled motor fluctuations (TEMPO-3 [NCT0452499]). Sustained efficacy was also observed in TEMPO-4, a 58-week open-label extension trial. Continued PD symptom control with tavapadon may delay levodopa initiation when used as monotherapy or reduce the need for levodopa dose escalation when used as adjunct therapy, potentially ameliorating the risk of motor complications associated with long-term oral levodopa.
Design/Methods:
The TEMPO-4 trial enrolled levodopa-naive participants from TEMPO-1 and TEMPO-2, participants receiving stable levodopa treatment from TEMPO-3, and de novo participants receiving stable levodopa treatment. This TEMPO-4 post hoc analysis assessed levodopa initiation in participants enrolled from TEMPO-1 and TEMPO-2 and levodopa dose adjustments in participants enrolled from TEMPO-3 and de novo participants.
Results:
The analysis across the TEMPO trials demonstrated that tavapadon treatment was associated with a stable or reduced need for levodopa. In the early PD cohorts (TEMPO-1 and TEMPO-2 extensions), most participants (86.4% to 94.0%) avoided initiating levodopa over the treatment period (previously treated, 85 weeks of treatment; previously untreated, 58 of weeks treatment). For those already receiving tavapadon adjunctive to levodopa (TEMPO-3 extension or newly enrolled participants), the drug rarely necessitated dose adjustments. Most patients (81.3% to 87.6%) kept their levodopa dose stable. When modifications were needed, patients were twice as likely to reduce their levodopa dose (∼10%) than to increase it (∼5%), keeping the mean daily dose under 1000 mg.
Conclusions:
After a total of 14-20 months of tavapadon treatment, ~90% of participants did not require levodopa initiation or dose increases.
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