Abstract Details

Title No PD Dyskinesia Scale Protects Against Placebo Responses: A Comparison of Multiple Scales

Topic Movement Disorders

Presentation(s) P04 - (-)

Poster/Presentation
Number 187

Objective

Background BACKGROUND: Numerous scales assess dyskinesia in PD, variably focusing on anatomical distribution, phenomenology, time, severity and disability. No study has compared the relative ability to detect change to an established therapy and the placebo response rates by scale.

Design/Methods DESIGN/METHODS: We conducted a 61 subject randomized placebo-controlled trial of amantadine (31) and placebo (30), assessing dyskinesia at baseline, four and eight weeks using seven different dyskinesia scales. Focusing on the three scales able to detect significant amantadine related improvements, (Lang-Fahn Dyskinesia Scale (LF), Parkinson's Disease Dyskiniesia - 26 item (PDD-26) and the Unified Dyskinesia Rating Scale (UDysRS, we determined their sensitivity to changes on placebo treatment. Using the Clinical Global Impression-change (CGI-c) score at the end of the study, we identified placebo responders (modified CGI-c score of ? 3, representing at least minimal clinically pertinent improvement) and non-responders. We then compared score changes on the three scales for placebo-treated subjects using repeated measures ANOVA (RM-ANOVA) or non-parametric analyses (Friedman's ANOVA with follow-up Wilcoxon tests) as appropriate.

Results RESULTS: Based on CGI-C score, 12 patients were classified as placebo-responders and 18 patients were classified as non-responders. None of the three scales were resistant to placebo effects (LF (p = 0.81), PDD-26 (p = 0.69), UDysRS (p = 0.46)), and placebo-associated improvements occurred regardless of whether the scale was anchored in subjective (LF, PDD-26) or combined subjective-objective data sources (UDysRS).

Conclusions CONCLUSIONS: Placebo-associated improvements were not scale-specific, and placebo responses could not be mitigated by currently available scales. Placebo-associated improvements may be implicit to the basic biochemistry of PD and the nature of placebo-controlled trials.

Authors/Disclosures
Christopher Goetz, MD, FAAN (Rush University Medical Center) PRESENTER	The institution of Dr. Goetz has received research support from Michael J. Fox Foundation. The institution of Dr. Goetz has received research support from NIH. The institution of Dr. Goetz has received research support from Department of Defense. Dr. Goetz has received publishing royalties from a publication relating to health care. Dr. Goetz has received publishing royalties from a publication relating to health care. Dr. Goetz has received publishing royalties from a publication relating to health care.
	No disclosure on file
Kathryn A. Chung, MD (Oregon Health Sciences Univ)	The institution of Dr. Chung has received research support from Department of Veteran's Affairs.
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center)	Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoparkinson. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. 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 $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 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 $5,000-$9,999 for serving as a Consultant for NanoPharmasolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll BioPharma. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Cerevance. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clario. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sumitomo. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Taurus Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sorriddi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Contera. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alterity Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Convatec Inc. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Knight Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biorasi. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medicure Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock. 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. The institution of Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Hauser has or had stock in Inhibikase.Dr. Hauser has or had stock in Axial Therapeutics.Dr. Hauser has or had stock in Enterin.Dr. Hauser has or had stock in Photopharmics. 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 Biogen MA. 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 Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. 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 Amneal Pharmaceuticals. The institution of Dr. Hauser has received research support from Motric Bio, Inc.. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research Company. The institution of Dr. Hauser has received research support from Teva Branded Pharmaceuticals. The institution of Dr. Hauser has received research support from Truebinding, Inc.. The institution of Dr. Hauser has received research support from Jazz Pharmaceuticals. The institution of Dr. Hauser has received research support from Ipsen. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Janis M. Miyasaki, MD, MEd, FAAN (University of Alberta/Alberta Health Services)	Dr. Miyasaki has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for ��ɫ��. Dr. Miyasaki has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Oxford University Press. The institution of Dr. Miyasaki has received research support from PCORI. The institution of Dr. Miyasaki has received research support from Canadian Consortium on Neurodegeneration in Aging. The institution of Dr. Miyasaki has received research support from University Hospital Foundation. The institution of Dr. Miyasaki has received research support from Social Science and Health Research Council. The institution of Dr. Miyasaki has received research support from Parkinson Society Canada. The institution of Dr. Miyasaki has received research support from Parkinson Foundation. The institution of Dr. Miyasaki has received research support from Parkinson Foundation.
Anthony P. Nicholas, MD, PhD (University of Alabama at Birmingham)	Dr. Nicholas has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Fenwick. Dr. Nicholas has received publishing royalties from a publication relating to health care.
Werner Poewe, MD (University Hospital of Neurology)	Werner Poewe, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Affiris . Werner Poewe, MD has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alterity, AbbVie, BIAL, Biogen, Britannia, Lilly, Lundbeck, Neuroderm, Neurocrine, Denali Pharmaceuticals, ,Roche, Takeda, UCB and Zambon . Werner Poewe, MD has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie, Britannia, BIAL, STADA, Lundbeck, Zambon. The institution of Werner Poewe, MD has received research support from MJFF; EU Horizon programme. Werner Poewe, MD has a non-compensated relationship as a Committee member with Movement Disorder Society that is relevant to AAN interests or activities.
Klaus Seppi, MD	Dr. Seppi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ONO . Dr. Seppi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Seppi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIAL. Dr. Seppi 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. Seppi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Seppi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Seppi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bial. Dr. Seppi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Seppi has received research support from MJFF. The institution of Dr. Seppi has received research support from EU. The institution of Dr. Seppi has received research support from FWF Austrian Science Fund,.
Olivier Rascol, MD, PhD (Departments of Clinical Pharmacology and Neurosciences-CIC9302/INSERM 825)	Dr. Rascol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie, Acorda, Aguettant, Alkahest, AlzProtect, Apopharma, Astrazeneca, Axovant, Bial, Biogen, Britannia, Buckwang, Centogene, Cerevel, Clevexel, Contera, GE Healthcare, Handltherapeutic, Ionis, Irlab, Jazz, Kyowa, LGD Nuvamid, Lundbeck, Merck, Merz, MundiPharma, Neuralight, Neuratris, Neuroderm, Novartis, ONO Pharma, Orion Pharma, Osmotica, Oxford Biomedica, Parexel, PD Neurotechnology, Pfizer, Polycaps, Prexton, Roche Therapeutics, Sanofi, Scienture, Servier,Sombiotech, Sunovion, Supernus, Synagile, Thelonius Mind, Takeda, Théranexus, Teva, Tools4patient, UCB, Vision 2 voice, XenoPort, XO, Zambon . Dr. Rascol has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie, Acorda, Aguettant, Alkahest, AlzProtect, Apopharma, Astrazeneca, Axovant, Bial, Biogen, Britannia, Buckwang, Centogene, Cerevel, Clevexel, Contera, GE Healthcare, Handltherapeutic, Ionis, Irlab, Jazz, Kyowa, LGD Nuvamid, Lundbeck, Merck, Merz, MundiPharma, Neuralight, Neuratris, Neuroderm, Novartis, ONO Pharma, Orion Pharma, Osmotica, Oxford Biomedica, Parexel, PD Neurotechnology, Pfizer, Polycaps, Prexton, Roche Therapeutics, Sanofi, Scienture, Servier,Sombiotech, Sunovion, Supernus, Synagile, Thelonius Mind, Takeda, Théranexus, Teva, Tools4patient, UCB, Vision 2 voice, XenoPort, XO, Zambon . Dr. Rascol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BIAL. Dr. Rascol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for MEDIZIN ACADEMY. The institution of Dr. Rascol has received research support from Agence Nationale de la Recherche (ANR), CHU de Toulouse, France-Parkinson, INSERM-DHOS Recherche Clinique Translationnelle, MJFox Foundation, Programme Hospitalier de Recherche Clinique, European Commission (FP7, H2020).
Mark Stacy, MD (MUSC Department of Neurology)	Dr. Stacy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biovie. Dr. Stacy has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for National Institute of Aging. Dr. Stacy has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Dartmouth. Dr. Stacy has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Movement Disorders Journal.
	No disclosure on file
John G. Nutt, MD, FAAN (Oregon Health & Science University)	No disclosure on file
Caroline M. Tanner, MD, PhD, FAAN (University of California San Francisco, Weill Institute for Neurosciences)	Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Evidera. Dr. Tanner has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Tanner has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaceuticals/Cavion. Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bial . Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Supernus. Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche Genentech. The institution of Dr. Tanner has received research support from Gateway LLC. The institution of Dr. Tanner has received research support from Roche\Genentech. The institution of Dr. Tanner has received research support from Michael J Fox Foundation . The institution of Dr. Tanner has received research support from National Institute of Health . The institution of Dr. Tanner has received research support from Department of Defense. Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving as a Faculty, CME presentation with Medscape /WebND.
	No disclosure on file
Jean A. Jaglin, RN (Rush University Medical Center)	No disclosure on file
	No disclosure on file

��ɫ����

��ɫ����

��ɫ��

��ɫ��