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Abstract Details

Continuous, Subcutaneous Apomorphine Infusion for Persistent Motor Fluctuations in Parkinson’s Disease: Full results of the AP2-3000 open-label study
Movement Disorders
S32 - Movement Disorders: Trials (4:54 PM-5:06 PM)
008

CSAI delivered using a wearable pump has been used worldwide to treat motor fluctuations in PD patients, but there are few prospective evidence-based trials performed. We report here the final 52-week results of the AP2-3000 study.

Evaluate long-term safety and efficacy of continuous subcutaneous apomorphine infusion (CSAI) for motor fluctuations in Parkinson’s disease (PD) patients treated in United States (US) settings.

This open-label study (clinicaltrials.gov NCT02339064) enrolled PD patients with ≥3 hours daily OFF time despite optimized antiparkinsonian therapy (levodopa plus ≥1 additional PD medication). Patients were titrated to optimal CSAI rates for best efficacy and minimal adverse events (AEs) before entering a 52-week maintenance period.

Of the 99 patients enrolled, 85 entered maintenance, 69 completed 12 weeks, and 48 completed 52-week maintenance treatment. The mean ± SD daily dose through Week 52 was 45.2 ± 23.1mg. Treatment-related AEs included infusion site nodules (77.8%), dyskinesia (38.4%), nausea (29.3 %), infusion site erythema (27.3%), and somnolence (25.3%), all of which occurred more frequently during the dose titration and optimization period. At Maintenance Week 12, daily OFF time decreased by a mean ± SD -3.0 ± 3.2 hours from baseline (primary efficacy endpoint), and ON time without troublesome dyskinesia increased by 3.1 ± 3.4 hours. Overall, 68.0% of patients rated themselves “much/very much” improved and mean daily levodopa and levodopa equivalent doses decreased by -198mg and -283mg, respectively. Responder analysis at Maintenance Week 12 showed that 62.1% of patients achieved ≥2 hours improvement in daily OFF from Baseline. Endpoints at Week 52 were consistent with Week 12 improvements.

CSAI reduced OFF time, increased ON time without troublesome dyskinesia, and allowed for oral PD medication reduction in patients inadequately controlled by optimized levodopa therapy. AEs were consistent with prior studies of CSAI in the PD population.

Authors/Disclosures
Stuart H. Isaacson, MD, FAAN (Parkinson's Dis & Mov Dis Ctr of Boca Raton)
PRESENTER
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.
Gianpiera Ceresoli-Borroni, PhD (Supernus Pharmaceuticals) Dr. Ceresoli-Borroni has nothing to disclose.
Alberto J. Espay, MD, FAAN (University of Cincinnati) Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuroderm. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Herantis Pharma. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus (formerly USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Synaps Dx. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AskBio. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Supernus (formerly, USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Avion Pharmaceuticals. The institution of Dr. Espay has received research support from NIH. The institution of Dr. Espay has received research support from Michael J Fox Foundation for Parkinson's Research. Dr. Espay has received intellectual property interests from a discovery or technology relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care.
Rajesh Pahwa, MD, FAAN (University of Kansas Medical Center) Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 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 $50,000-$99,999 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 Acorda. 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 Cala Health. Dr. Pahwa has received personal compensation in the range of $0-$499 for serving as a Consultant for Global Kinetics. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. 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 $500-$4,999 for serving as a Consultant for Allevion. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Pahwa has received personal compensation in the range of $500-$4,999 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 $5,000-$9,999 for serving as a Consultant for Neuroderm. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Photopharmics. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Wren. 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 Biohaven. The institution of Dr. Pahwa has received research support from Boston Scientific. The institution of Dr. Pahwa has received research support from EIP. The institution of Dr. Pahwa has received research support from Global Kinetics. The institution of Dr. Pahwa has received research support from Amneal. The institution of Dr. Pahwa has received research support from Neuraly. The institution of Dr. Pahwa has received research support from Parkinson Foundation. The institution of Dr. Pahwa has received research support from Pharma 2B. 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 Theranexus. The institution of Dr. Pahwa has received research support from Theravance. The institution of Dr. Pahwa has received research support from Voyager. The institution of Dr. Pahwa has received research support from Neuroderm.
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 Sunovion Pharmaceuticals Inc. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia Pharmaceuticals Inc. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Kyowa Kirin. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Adamas. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Accorda. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NQ Medical. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 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 Regenx Bio . Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 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 Sunovion. 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. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Accorda. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Agarwal has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for AbbVie. An immediate family member of Dr. Agarwal has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Ariz Precision Medicine. Dr. Agarwal has stock in ACTINIUM PHARMACEUTICALS INC. Dr. Agarwal has stock in ALDEYRA THERAPEUTICS INC. Dr. Agarwal has stock in ALTIMMUNE INC . Dr. Agarwal has stock in Aptynix Inc. Dr. Agarwal has stock in Aquestive Therapeutics. Dr. Agarwal has stock in Aurinia Pharmaceuticals. Dr. Agarwal has stock in Corcept Therapeutics. Dr. Agarwal has stock in Catalyst Pharmaceuticals. Dr. Agarwal has stock in Curis Inc. Dr. Agarwal has stock in Citius Pharmaceuticals. Dr. Agarwal has stock in Eigor Biopharma. Dr. Agarwal has stock in Fortress Biotech. Dr. Agarwal has stock in Gevo Inc. Dr. Agarwal has stock in G1 Therapeutics. Dr. Agarwal has stock in Jounce Therapeutics. Dr. Agarwal has stock in Marinus Pharnmaceuticals. Dr. Agarwal has stock in OVID Therapeutics. Dr. Agarwal has stock in Pieris Pharmaceuticals. Dr. Agarwal has stock in SIGA Technologies. Dr. Agarwal has stock in TG Therapeutics. Dr. Agarwal has stock in ARBUTUS BIOPHARMA CORP . Dr. Agarwal has stock in ATYR PHARMA INC . Dr. Agarwal has stock in ASSERTIO HOLDINGS INC . Dr. Agarwal has stock in BLUEBIRD BIO INC . Dr. Agarwal has stock in CONCERT PHARMACEUTICALS INC . Dr. Agarwal has stock in CORVUS PHARMACEUTICALS INC . Dr. Agarwal has stock in GALECTO INC . Dr. Agarwal has stock in GENETIC TECHNOLOGIES LTD . Dr. Agarwal has stock in GLYCOMIMETICS INC. Dr. Agarwal has stock in IMARA INC . Dr. Agarwal has stock in INNATE PHARMA. Dr. Agarwal has stock in INTELLIA THERAPEUTICS INC . Dr. Agarwal has stock in KEMPHARM INC COM. Dr. Agarwal has stock in LAVA THERAPEUTICS . Dr. Agarwal has stock in MEREO BIOPHARMA GROUP PLC. Dr. Agarwal has stock in ORGENESIS INC. Dr. Agarwal has stock in OVID THERAPEUTICS INC . Dr. Agarwal has stock in PHASEBIO PHARMACEUTICALS INC. Dr. Agarwal has stock in PROTALIX BIOTHERAPEUTICS INC. Dr. Agarwal has stock in PUMA BIOTECHNOLOGY INC . Dr. Agarwal has stock in TERNS PHARMACEUTICALS INC. Dr. Agarwal has stock in VIKING THERAPEUTICS INC. Dr. Agarwal has stock in WAVE LIFE SCIENCES LTD. The institution of Dr. Agarwal has received research support from Acadia Pharmaceuticals. The institution of Dr. Agarwal has received research support from Adamas. The institution of Dr. Agarwal has received research support from Annexon. 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 Merck & Co. The institution of Dr. Agarwal has received research support from NIH/NWern Univ/PSG. The institution of Dr. Agarwal has received research support from Roche . The institution of Dr. Agarwal has received research support from Supernus.
Holly A. Shill, MD, FAAN (Barrow Neurology Clinics) Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage Biogen. Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KeifeRx. Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Praxis Precision Medicine. Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl Inc.
Jennifer S. Hui, MD (University of Southern California) Dr. Hui has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion. Dr. Hui has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion. The institution of Dr. Hui has received research support from Roche. The institution of Dr. Hui has received research support from Abbvie. Dr. Hui has received personal compensation in the range of $500-$4,999 for serving as a Roundtable speaker with Medscape .
Khashayar Dashtipour, MD, PhD Dr. Dashtipour has nothing to disclose.
Mark F. Lew, MD, FAAN (USC School of Medicine) Dr. Lew has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus. Dr. Lew has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for kyowa. Dr. Lew has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for neurocrine. Dr. Lew has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acorda. Dr. Lew has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia. Dr. Lew has received personal compensation in the range of $500-$4,999 for serving as a Consultant for RegenXBio. Dr. Lew has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Lew has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Kyowa. Dr. Lew has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for acorda. The institution of Dr. Lew has received research support from MJFF. Dr. Lew has received research support from NIH.
Peibing Qin No disclosure on file
Azmi *use 306680 Nasser, PhD (Supernus Pharmaceuticals, Inc.) Dr. Nasser has received personal compensation for serving as an employee of Supernus Pharmaceuticals, Inc..
Peter A. LeWitt, MD (Henry Ford Hospital - Franklin Pointe) Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acorda Therapeutics. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal Pharmaceuticals. Dr. LeWitt has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for US WorldMeds LLC. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin Inc. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe-NeuroDerm Neuropharma. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bukwang Pharmaceuticals. Dr. LeWitt has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. Dr. LeWitt 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 CLINICAL NEUROPHARMACOLOGY.