Parkinson's Disease (PD) Clinical Trial
Official title:
A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in advanced PD participants to achieve reduction in motor fluctuations. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world. In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02170376 -
The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics
|
Phase 1 | |
| Completed |
NCT02169479 -
Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa
|
Phase 1 | |
| Completed |
NCT02169895 -
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide
|
Phase 1 | |
| Completed |
NCT02778594 -
Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Benserazide
|
Phase 1 | |
| Completed |
NCT02274766 -
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
|
Phase 3 | |
| Completed |
NCT02169453 -
Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa
|
Phase 1 | |
| Withdrawn |
NCT06118294 -
Efficacy of Probiotics for Parkinson Disease (PD)
|
N/A | |
| Recruiting |
NCT05916157 -
An Observational Study of Subcutaneous Infusion of ABBV-951 to Assess Change in Disease Activity and Adverse Events In Adult Japanese Participants With Advanced Parkinson's Disease
|
||
| Completed |
NCT03033498 -
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease
|
Phase 1 | |
| Completed |
NCT02169427 -
An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites
|
Phase 1 | |
| Completed |
NCT02834507 -
Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients
|
Phase 2 | |
| Active, not recruiting |
NCT04379050 -
Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
|
Phase 3 | |
| Completed |
NCT02169440 -
Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin
|
Phase 1 | |
| Completed |
NCT02202551 -
Open-Label Safety Study of ADS-5102 in PD Patients With LID
|
Phase 3 | |
| Completed |
NCT01398748 -
Intranasal Glutathione in Parkinson's Disease
|
Phase 1 | |
| Recruiting |
NCT06107426 -
Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
|
||
| Completed |
NCT02169466 -
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide
|
Phase 1 | |
| Recruiting |
NCT03732898 -
Coordinated Reset Deep Brain Stimulation
|
N/A | |
| Completed |
NCT02799381 -
A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)
|
Phase 3 | |
| Terminated |
NCT03829657 -
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
|
Phase 3 |