Abstract Details

Title Characterizing a Parkinson's Disease Population Inadequately Controlled by Oral Therapy: Baseline Characteristics of the Phase 3 Clinical Program for Foslevodopa/Foscarbidopa

Topic Movement Disorders

Presentation(s) P2 - Poster Session 2 (11:45 AM-12:45 PM)

Poster/Presentation
Number 5-006

Objective The aim of this analysis was to characterize the patient populations of two pivotal clinical trials with foslevodopa/foscarbidopa (LDP/CDP, also referred to as ABBV-951), an investigational drug for Parkinson’s Disease (PD).

Background While identification of advanced PD (aPD) continues to be a challenge, new tools have emerged to help clinicians determine if patients have reached aPD. Recently, a validated tool known as MANAGE-PD was launched to help clinicians identify suboptimal PD symptom control and categorize patients with advancing PD as either controlled, inadequately controlled possibly needing treatment optimization, or potentially eligible for device-aided therapies (DATs).

Design/Methods This post-hoc analysis evaluated the baseline characteristics of patients enrolled in two ABBV-951 phase 3 studies (one double-blind/double-dummy, NCT04380142; and one open-label safety, NCT03781167). Additionally, in the open-label study, the MANAGE-PD criteria (section 1 and 2) was applied to the participants prospectively, which may further validate the use of the tool in identifying patients eligible for DATs.

Results In the double-blind (n=141) and open-label (n=244) studies, the percentages of participants at baseline in the 55-74 age category were 66.7% and 73.4%, that had daily off time >3 hours were 97.2% and 88.1%, that had a 0-3 Hoehn and Yahr stage were 96.5% and 94.7%, and had time to occurrence of motor fluctuations as >3 years of 73.0% and 77.5%, respectively. Based on the MANAGE-PD categorization, in the open label-study all patients were considered to be inadequately controlled with the current treatment regimen, with 14.8% possibly benefitting from current treatment optimization, and 85.2% as potentially benefitting from DAT.

Conclusions The vast majority of patients from the pivotal trials in the LDP/CDP clinical program were consistent with populations characterized as ‘advanced’ and eligible for a DAT such as ABBV-951, which was substantiated using the MANAGE-PD categorization, adding to the validation of this tool.

Authors/Disclosures
Pavnit Kukreja, PharmD (AbbVie) PRESENTER	Dr. Kukreja has received personal compensation for serving as an employee of AbbVie. Dr. Kukreja has stock in AbbVie.
Per Odin	Per Odin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Per Odin has received personal compensation in the range of $0-$499 for serving as a Consultant for Britannia. Per Odin has received personal compensation in the range of $0-$499 for serving as a Consultant for Convatec. Per Odin has received personal compensation in the range of $0-$499 for serving as a Consultant for UCB.
Rajesh Pahwa, MD, FAAN (University of Kansas Medical Center)	Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ACADIA. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Insightec. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jaaz. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Photopharmics. The institution of Dr. Pahwa has received research support from Abbott. The institution of Dr. Pahwa has received research support from Abbvie. The institution of Dr. Pahwa has received research support from Biogen. The institution of Dr. Pahwa has received research support from Parkinson Foundation. The institution of Dr. Pahwa has received research support from Roche. The institution of Dr. Pahwa has received research support from Sage. The institution of Dr. Pahwa has received research support from Sun Pharma. The institution of Dr. Pahwa has received research support from Theravance. The institution of Dr. Pahwa has received research support from Neuroderm. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Blue Rock. The institution of Dr. Pahwa has received research support from Cerevance. The institution of Dr. Pahwa has received research support from Fasikl. The institution of Dr. Pahwa has received research support from Scion. The institution of Dr. Pahwa has received research support from UCB. The institution of Dr. Pahwa has received research support from Ono. The institution of Dr. Pahwa has received research support from Intra-cellular Therapies. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Michael J Fox Foundation . The institution of Dr. Pahwa has received research support from Neuron 23. The institution of Dr. Pahwa has received research support from Roche.
Jill M. Farmer, DO, MPH	Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Supernus. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acadia. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. Dr. Farmer has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Live. The institution of Dr. Farmer has received research support from Parkinson's Foundation.
Thomas E. Kimber, PhD, FRACP (Royal Adelaide Hospital)	Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Kimber 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. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Seqiris. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Kimber has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Pfizer.
Bruno Bergmans (AZ St-Jan Brugge)	Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie Inc.. Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz GmbH. Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. The institution of Bruno Bergmans has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie Inc.. The institution of Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merz GmbH. The institution of Bruno Bergmans has received research support from Abbvie Inc.. The institution of Bruno Bergmans has received research support from Merz GmbH. Bruno Bergmans has a non-compensated relationship as a MDS Young Members Group Steering Committee Vice-Chair with International Parkinson and Movement DIsorder Society (MDS) that is relevant to AAN interests or activities.
	No disclosure on file
	No disclosure on file
Resmi Gupta (Abbvie Inc)	Resmi Gupta has nothing to disclose.
Connie H. Yan, PhD, PharmD (AbbVie Inc)	Dr. Yan has received personal compensation for serving as an employee of AbbVie Inc. Dr. Yan has stock in AbbVie Inc.
Lars Bergmann, MD (Abbvie GmbH & Co)	Lars Bergmann has received personal compensation for serving as an employee of Abbvie. Lars Bergmann has stock in Abbvie.
Angelo Antonini, MD	Dr. Antonini 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. Antonini 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. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Antonini has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for THERAVANCE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ROCHE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ABBVIE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ZAMBON. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BOEHRINGER.

��ɫ��

��ɫ��