Abstract Details

Title Levodopa Initiation or Dose Adjustments in TEMPO-4: A 58-Week Open-label Trial of Tavapadon for Treatment of PD

Topic Movement Disorders

Presentation(s) S26 - Movement Disorders: Clinical Trials and Therapeutics (2:12 PM-2:24 PM)

Poster/Presentation
Number 007

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.

Authors/Disclosures
William Ondo, MD (Methodist Neurological Institute) PRESENTER	Dr. Ondo has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Ondo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ACADIA. Dr. Ondo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Dr. Ondo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. The institution of Dr. Ondo has received research support from Cerevel. The institution of Dr. Ondo has received research support from SCION. The institution of Dr. Ondo has received research support from Harmony. Dr. Ondo has received publishing royalties from a publication relating to health care.
Meredith Hatcher, PA (Texas Movement Disorder Specialists)	Mrs. Hatcher has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Mrs. Hatcher has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amneal. Mrs. Hatcher has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie.
Michael Soileau, MD, FAAN (Texas Movement Disorder Specialists, PLLC)	The institution of Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. The institution of Dr. Soileau has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Soileau has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. The institution of Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal Pharmaceuticals. Dr. Soileau has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. The institution of Dr. Soileau has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merz. The institution of Dr. Soileau has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Soileau has received research support from Abbvie. The institution of Dr. Soileau has received research support from Cerevel. The institution of Dr. Soileau has received research support from Praxis. The institution of Dr. Soileau has received research support from CND Life Sciences. The institution of Dr. Soileau has received research support from Teva. The institution of Dr. Soileau has received research support from Abbott. The institution of Dr. Soileau has received research support from Jazz Pharmaceuticals. The institution of Dr. Soileau has received research support from Scion. Dr. Soileau has received publishing royalties from a publication relating to health care. Dr. Soileau has a non-compensated relationship as a Past President with Texas Neurological Society that is relevant to AAN interests or activities.
James L. Eubanks, PhD (Octave Biocience)	Dr. Eubanks has received personal compensation for serving as an employee of Octave. Dr. Eubanks has stock in TG Therapeutics. Dr. Eubanks has stock in Medtronic.
Tracy F. Nicholson, PhD (Cerevel)	Dr. Nicholson has received personal compensation for serving as an employee of AbbVie. Dr. Nicholson has stock in AbbVie.
Rohit Dhall, MD, FAAN (University of Arkansas for Medical Sciences)	Dr. Dhall has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Best Doctors Inc. Dr. Dhall has stock in Verve Therapeutics Inc. Dr. Dhall has stock in Roche Holding Limited. Dr. Dhall has stock in Enliven Therapeutics Inc. The institution of Dr. Dhall has received research support from Amneal. The institution of Dr. Dhall has received research support from Neuroderm. The institution of Dr. Dhall has received research support from Cerevel Therapeutics. The institution of Dr. Dhall has received research support from Neurocrine. The institution of Dr. Dhall has received research support from Neuraly. The institution of Dr. Dhall has received research support from SPARC. The institution of Dr. Dhall has received research support from Pharma2B. The institution of Dr. Dhall has received research support from Alexion. The institution of Dr. Dhall has received research support from Parkinsons Foundation. The institution of Dr. Dhall has received research support from UCB Pharma. The institution of Dr. Dhall has received research support from Inhibikase Therapeutics. The institution of Dr. Dhall has received research support from Amylyx Pharma.

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