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Abstract Details

Efficacy and Safety of Tavapadon, an Orally Administered, Once-daily, Selective D1/D5 Partial Dopamine Agonist, Adjunctive to Levodopa for Treatment of Parkinson’s Disease with Motor Fluctuations
Movement Disorders
S37 - Movement Disorders: Clinical Trials (1:24 PM-1:36 PM)
003

Tavapadon is an investigational, oral, once-daily selective D1/D5 partial dopamine agonist. Selective, partial D1/D5 agonism may provide a balance of dopamine signaling that improves PD motor symptoms while potentially minimizing certain adverse events (AEs) associated with activation of D2/D3 receptors.

To evaluate the efficacy, safety, and tolerability of tavapadon adjunctive to levodopa  in adults with Parkinson’s disease (PD) and motor fluctuations.
TEMPO-3 (NCT04542499) is a phase 3, placebo-controlled, double-blind clinical trial evaluating adjunctive therapy with tavapadon in adults experiencing motor fluctuations (modified Hoehn and Yahr stage 2-3 in the ON state, minimum 2.5 h of OFF time on 2 consecutive diary days) while receiving stable levodopa treatment. Participants were randomly assigned (1:1) to receive adjunctive tavapadon (titrated to maximum tolerated flexible dose: 5–15 mg once daily) or placebo. Change from baseline in total daily ON time without troublesome dyskinesia (Hauser diary 2-day average) was the primary endpoint. Key secondary endpoints included change from baseline in total daily OFF time and AEs.
Adults aged 40-80 years (N=507) were enrolled. Treatment with tavapadon (5–15 mg once daily) significantly increased total daily ON time without troublesome dyskinesia by 1.1 hours relative to placebo (1.7 hours vs 0.6 hours, respectively; P<0.0001). A significant reduction versus placebo in change from baseline in daily OFF time was also observed. Tavapadon’s safety profile was consistent with prior clinical trials and the majority of AEs were mild to moderate in severity. 
These findings in adults with PD and motor fluctuations demonstrate the efficacy and acceptable safety profile of tavapadon as adjunctive therapy to levodopa. Tavapadon as monotherapy in early PD (TEMPO-1 and TEMPO-2) and the long-term use of tavapadon (open-label extension; TEMPO-4) are being evaluated in ongoing phase 3 trials.
Authors/Disclosures
Hubert H. Fernandez, MD, FAAN (Center for Neurological Restoration, Cleveland Clinic)
PRESENTER 		Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Intrance. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Fernandez has received publishing royalties from a publication relating to health care. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as a Steering Committee/Advisory Committee Member with Parkinson Study Group.
Stuart H. Isaacson, MD, FAAN (Parkinson's Dis & Mov Dis Ctr of Boca Raton) The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acorda. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for adamas. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuroderm. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for adamas. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center) Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Global Kinetics Consulting (GKC). Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroDerm. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scion Neurostim LLC. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tolmar Inc.. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pharma 2 B. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vivifi Biotech. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage Therapeutics. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ovid Therapeutics. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AgeX Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avanex. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MDCE Suzhou. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedRhythms. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PDNeurotechnology. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Regenxbio. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Tremor Research Support Group. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tris Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $0-$499 for serving as a Consultant for Canfield Scientific. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Forsee Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KiefeRx. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Intrance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Truebinding. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Serina Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nano PharmaSolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. The institution of Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stoparkinson. The institution of Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Photopharmics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Cerevel. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Inhibikase. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has stock in Inhibikase. Dr. Hauser has stock in Axial Therapeutics. Dr. Hauser has stock in Enterin. Dr. Hauser has stock in Revance Therapeutics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Aeon Biopharma. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Bukwang Pharmaceutical Co., Ltd.. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuraly Inc.. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Sanofi Pharmaceuticals. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from UCB BioPharma. The institution of Dr. Hauser has received research support from UCB. The institution of Dr. Hauser has received research support from MJFF. The institution of Dr. Hauser has received research support from Biogen. The institution of Dr. Hauser has received research support from Alexza Pharmaceuticals. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Pinky Agarwal, MD, FAAN (Evergreen Health) Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia Pharmaceuticals Inc. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe Pharma. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion Pharmaceuticals. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AskBio. An immediate family member of Dr. Agarwal has stock in ALDEYRA THERAPEUTICS INC. An immediate family member of Dr. Agarwal has stock in Curis Inc. An immediate family member of Dr. Agarwal has stock in Citius Pharmaceuticals. An immediate family member of Dr. Agarwal has stock in Fortress Biotech. An immediate family member of Dr. Agarwal has stock in TG Therapeutics. An immediate family member of Dr. Agarwal has stock in ATYR PHARMA INC . An immediate family member of Dr. Agarwal has stock in CORVUS PHARMACEUTICALS INC . An immediate family member of Dr. Agarwal has stock in LAVA THERAPEUTICS . An immediate family member of Dr. Agarwal has stock in OVID THERAPEUTICS INC . An immediate family member of Dr. Agarwal has stock in TERNS PHARMACEUTICALS INC. An immediate family member of Dr. Agarwal has stock in VIKING THERAPEUTICS INC. Dr. Agarwal has stock in WAVE LIFE SCIENCES LTD. An immediate family member of Dr. Agarwal has stock in ProQr Therapeutics. An immediate family member of Dr. Agarwal has stock in Mind Medicine. An immediate family member of Dr. Agarwal has stock in Lyra Therapeutics. An immediate family member of Dr. Agarwal has stock in Larimer Therapeutics. An immediate family member of Dr. Agarwal has stock in Lantern Pharma. An immediate family member of Dr. Agarwal has stock in Black Diamond Therapeutics. An immediate family member of Dr. Agarwal has stock in Amylyx Pharma. An immediate family member of Dr. Agarwal has stock in Palisade Bio. An immediate family member of Dr. Agarwal has stock in Inozyme Pharma. An immediate family member of Dr. Agarwal has stock in Pyxis Oncology. An immediate family member of Dr. Agarwal has stock in Vertex Pharmaceuticals. An immediate family member of Dr. Agarwal has stock in Vyne Therapeutics. An immediate family member of Dr. Agarwal has stock in Reviva Pharmaceuticals Hld. An immediate family member of Dr. Agarwal has stock in Immuneering Corp. An immediate family member of Dr. Agarwal has stock in Imunon Inc. An immediate family member of Dr. Agarwal has stock in Enlivex Therapeutics. An immediate family member of Dr. Agarwal has stock in Candel Therapeutics. An immediate family member of Dr. Agarwal has stock in Applied Digital Corp. An immediate family member of Dr. Agarwal has stock in Atai Life Sciences. An immediate family member of Dr. Agarwal has stock in Adma Biologics. The institution of Dr. Agarwal has received research support from Biogen . The institution of Dr. Agarwal has received research support from CHDI Foundation. The institution of Dr. Agarwal has received research support from Eli Lilly. The institution of Dr. Agarwal has received research support from MJ Fox. The institution of Dr. Agarwal has received research support from Roche . The institution of Dr. Agarwal has received research support from Supernus. The institution of Dr. Agarwal has received research support from Nova Nordisc. The institution of Dr. Agarwal has received research support from Inhibikase. The institution of Dr. Agarwal has received research support from Intracellular therapeurtics.
William Ondo, MD (Methodist Neurological Institute) 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.
Ariane Park, MD, MPH (Wexner Medical Center At The Ohio State University) An immediate family member of Dr. Park has stock in LucidHealth. The institution of Dr. Park has received research support from Parkinson Foundation. The institution of Dr. Park has received research support from National Institute of Neurological Disorders and Stroke. The institution of Dr. Park has received research support from Rho, Inc. The institution of Dr. Park has received research support from Cerevel Therapeutics. The institution of Dr. Park has received research support from Addex Therapeutics.
Lawrence W. Elmer, MD, PhD (Univ of Toledo Dept. of Neurology) Dr. Elmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acadia Pharmaceuticals. Dr. Elmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acorda Therapeutics. Dr. Elmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal Pharmaceuticals. Dr. Elmer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva Pharmaceuticals. The institution of Dr. Elmer has received research support from Vaccinex, Inc.. The institution of Dr. Elmer has received research support from Cynapsus Therapeutics, Inc.. The institution of Dr. Elmer has received research support from Lundbeck Pharmaceuticals, Inc.. The institution of Dr. Elmer has received research support from Intec Pharmaceuticals, Inc.. The institution of Dr. Elmer has received research support from Pharma Two B. The institution of Dr. Elmer has received research support from Acadia Pharmaceuticals, Inc.. The institution of Dr. Elmer has received research support from Impax Laboratories, LLC. The institution of Dr. Elmer has received research support from Prilenia Therapeutics. The institution of Dr. Elmer has received research support from Neuraly, Inc..
Daniel Kremens, MD, JD, FAAN (Sidney Kimmel Medical College At Thomas Jefferson University) Dr. Kremens has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Kremens has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Neurocrine. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Kremens has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Teva. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Kremens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cerevel. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for UCB.
Matthew Leoni No disclosure on file
Sridhar Duvvuri, PhD Dr. duvvuri has received personal compensation for serving as an employee of Cerevel. Dr. duvvuri has received personal compensation for serving as an employee of Abbvie. Dr. duvvuri has stock in Pfizer. Dr. duvvuri has stock in Cerevel. Dr. duvvuri has stock in Abbvie.
Cari D. Combs, MD (Biohaven Pharmaceuticals) Dr. Combs has received personal compensation for serving as an employee of Cerevel Therapeutics. Dr. Combs has received personal compensation for serving as an employee of AbbVie . Dr. Combs has stock in Biohaven Pharmaceuticals. Dr. Combs has stock in AbbVie . Dr. Combs has stock in Cerevel Therapeutics .
Erica Koenig, PhD Dr. Koenig has nothing to disclose.
Ih Chang Ih Chang has received personal compensation for serving as an employee of Cerevel. Ih Chang has received stock or an ownership interest from Cerevel Therapeutics.
Gina Pastino, PhD (Cerevel Therapeutics) Dr. Pastino has received personal compensation for serving as an employee of Cerevel Therapeutics. Dr. Pastino has received personal compensation for serving as an employee of PRA Health Sciences.
Stacey Tringali, PharmD Dr. Tringali has nothing to disclose.
Nicole Golonski, MPH Mrs. Golonski has received personal compensation for serving as an employee of Cerevel Therapeutics . Mrs. Golonski has received personal compensation for serving as an employee of Abbvie.
Raymond Sanchez, MD Dr. Sanchez has received personal compensation for serving as an employee of Cerevel Therapeutics .