Infusion of Apomorphine: Long-term Safety Study
NCT02339064 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2025-06-19
Summary
This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous apomorphine infusion in subjects with advanced Parkinson's Disease (PD) whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD.
Conditions
- Idiopathic Parkinson's Disease
Interventions
- DRUG
-
apomorphine infusion
Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
Sponsors & Collaborators
-
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Gianpiera Ceresoli-Borroni, PhD · Supernus Pharmaceuticals, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-28
- Primary Completion
- 2018-12-31
- Completion
- 2025-12-31
Countries
- United States
Study Locations
More Related Trials
-
Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months
NCT00200512 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
NCT02352363 ·Status: COMPLETED ·Phase: PHASE3
-
Staccato Apomorphine Single and Multi Dose PK
NCT03822364 ·Status: COMPLETED ·Phase: PHASE1
-
Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease
NCT02542696 ·Status: COMPLETED ·Phase: PHASE3
-
Monocentric, Prospective Study to Assess the Pharmacokinetic Profile of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease
NCT04887467 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
NCT03391882 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease
NCT06055985 ·Status: COMPLETED ·Phase: PHASE2
-
Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease
NCT04750226 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
NCT04006210 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease
NCT02267434 ·Status: COMPLETED ·Phase: PHASE1
-
Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients
NCT04778176 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
NCT02782481 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease
NCT03033498 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
NCT02469090 ·Status: COMPLETED ·Phase: PHASE3
-
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
NCT03877510 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
NCT03781167 ·Status: COMPLETED ·Phase: PHASE3
-
A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease
NCT02726386 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment
NCT03374917 ·Status: COMPLETED ·Phase: PHASE1
-
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
NCT01096186 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612
NCT01883505 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia
NCT01092065 ·Status: COMPLETED ·Phase: PHASE2
-
Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease
NCT04380142 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Autologous iNSC-DAP in the Treatment of Parkinson's Disease
NCT05901818 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations
NCT03670953 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes
NCT05979415 ·Status: TERMINATED ·Phase: PHASE2