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Abstract Details

Long-Term Treatment With Deutetrabenazine Is Associated With Continued Improvement in Tardive Dyskinesia (TD): Results From an Open-Label Extension Study
Movement Disorders
S4 - Clinical Trials in Movement Disorders (2:28 PM-2:39 PM)
009

In the 12-week ARM-TD and AIM-TD studies, the percentage of patients achieving ≥50% and ≥70% response was higher in the deutetrabenazine-treated group than the percentage of patients in the placebo group, and there were low rates of overall adverse events and discontinuations associated with deutetrabenazine.

To evaluate long-term efficacy of deutetrabenazine in patients with tardive dyskinesia (TD) by examining response rates from baseline in Abnormal Involuntary Movement Scale (AIMS) scores. Updated results of the responder analysis are reported here.
Patients with TD who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted or started deutetrabenazine 12 mg/day, titrating up to a maximum total daily dose of 48 mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration and a long-term maintenance phase (ongoing through Week 158). The cumulative proportion of AIMS responders from baseline was assessed; response rates for at least 50% and 70% improvement from baseline for each patient were evaluated. AlMS score was assessed by local site raters for this analysis.
343 patients enrolled in the extension study. At Week 54 (n=250; total daily dose [mean ± standard error]: 38.6±0.66 mg), 48% of patients achieved ≥50% response and 24% achieved ≥70% response. At Week 106 (n=169; total daily dose: 39.6±0.77 mg), 55% of patients achieved ≥50% response, and 30% achieved ≥70% response. At Week 145, (n=77; total daily dose: 39.2±1.12 mg), 74% of patients achieved ≥50% response and 52% achieved ≥70% response. Treatment was generally well tolerated. Exposure-adjusted incidence rates (EAIRs) of common AEs were headache (0.04, somnolence (0.06), anxiety (0.07), and depression (0.05).
Patients who received long-term treatment with deutetrabenazine achieved response rates that were indicative of clinically meaningful long-term treatment benefit.
Authors/Disclosures
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center)
PRESENTER 		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.
No disclosure on file
Hubert H. Fernandez, MD, FAAN (Center for Neurological Restoration, Cleveland Clinic) 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.
Stewart A. Factor, DO, FAAN (Emory University School of Medicine) Dr. Factor has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Factor has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Factor has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. The institution of Dr. Factor has received research support from Biohaven. The institution of Dr. Factor has received research support from Voyager. The institution of Dr. Factor has received research support from Neurocrine. The institution of Dr. Factor has received research support from Supernus. The institution of Dr. Factor has received research support from Prelinia. The institution of Dr. Factor has received research support from Medtronics. The institution of Dr. Factor has received research support from Boston Scientific. The institution of Dr. Factor has received research support from Sun Pharmaceuticals Advanced Research Company. The institution of Dr. Factor has received research support from Aspen. Dr. Factor has received publishing royalties from a publication relating to health care. Dr. Factor has received publishing royalties from a publication relating to health care. Dr. Factor has received publishing royalties from a publication relating to health care. Dr. Factor has received publishing royalties from a publication relating to health care.
Joohi Jimenez Shahed, MD (Icahn School of Medicine at Mount Sinai) Dr. Jimenez Shahed has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bracket Global LLC. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Medtronic. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alpha Omega. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for RegenXBio. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Praxis. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BlueRock Therapeutics. Dr. Jimenez Shahed has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for PhotoPharmics. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Emalex. The institution of Dr. Jimenez Shahed has received research support from Michael J Fox Foundation. The institution of Dr. Jimenez Shahed has received research support from Amneal. The institution of Dr. Jimenez Shahed has received research support from Annovis. The institution of Dr. Jimenez Shahed has received research support from SAGE. The institution of Dr. Jimenez Shahed has received research support from Ono Pharmaceuticals. The institution of Dr. Jimenez Shahed has received research support from BlueRock. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Faculty with Movement Disorders Society. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Faculty with 好色先生. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Grant Reviewer with Parkinson Foundation. Dr. Jimenez Shahed has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant on Research Grant with Florida Atlantic University. Dr. Jimenez Shahed has received personal compensation in the range of $0-$499 for serving as a Speaker with Tourette Association of America. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving as a Speaker with NACCME.
No disclosure on file
Juha M. Savola, MD, PhD (Spark Therapeutics, Inc) Dr. Savola has received personal compensation for serving as an employee of Teva Pharmaceuticals. Dr. Savola has received intellectual property interests from a discovery or technology relating to health care.
Karen E. Anderson Ms. Anderson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for teva. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AskBio. The institution of Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for novartis. The institution of Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Biogen. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. The institution of Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Ms. Anderson has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for neurocrine. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medscape. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for atheneum. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GLG. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a scientific advisor with CHDI.