Idiopathic Parkinson's Disease Clinical Trial
Official title:
A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist
Parkinson's disease is a major neurodegenerative disorder in which there is a progressive
loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of
dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a
precursor of DA that crosses the blood brain barrier, and also to the use of selective
inhibitors of MAO B, the major DA metabolising enzyme in man.
This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi
national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.)
versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects
with early idiopathic Parkinson's Disease.
The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score
from baseline to endpoint, was chosen based on regulatory guidance and prior use in other
trials in similar populations.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03665493 -
Dopamine Effect on Inhibitory Control
|
N/A | |
| Completed |
NCT02227355 -
Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease
|
N/A | |
| Completed |
NCT01026428 -
A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics
|
Phase 1/Phase 2 | |
| Completed |
NCT00664157 -
Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus
|
N/A | |
| Completed |
NCT04524143 -
The Acute Effect of Cervical Mobilization in Parkinson's Disease
|
N/A | |
| Completed |
NCT05107531 -
Investigation of Gait, Foot Pressure Distribution and Balance in Parkinson's Patients With Motor Freezing
|
||
| Completed |
NCT04524182 -
The Acute Effect of Lumbosacral Mobilization in Parkinson's Disease
|
N/A | |
| Completed |
NCT00985517 -
Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT01968031 -
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
|
Phase 3 | |
| Completed |
NCT01970813 -
Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
|
N/A | |
| Completed |
NCT01221948 -
Vercise Implantable Stimulator for Treating Parkinson's Disease
|
Phase 2 | |
| Terminated |
NCT01028586 -
MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)
|
Phase 3 | |
| Completed |
NCT00239564 -
Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT02240030 -
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
|
Phase 3 | |
| Completed |
NCT00400634 -
Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease
|
Phase 2 | |
| Completed |
NCT01227265 -
Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
|
Phase 3 | |
| Completed |
NCT02565628 -
PF-06669571 In Subjects With Idiopathic Parkinson's Disease
|
Phase 1 | |
| Completed |
NCT01606670 -
Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease
|
||
| Completed |
NCT01617135 -
Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
|
Phase 2 | |
| Terminated |
NCT00261781 -
Walking Capacity in Parkinson's Disease (PD-Walk)
|
N/A |