Parkinson's Disease Clinical Trial
Official title:
Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment
The primary objective of the trial was to investigate the efficacy of apomorphine continuous
subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor
fluctuations not well controlled on medical treatment.
The secondary objective of the study was to investigate the safety and tolerability of
apomorphine continuous subcutaneous therapy.
The primary efficacy variable is the mean change in time spent "OFF" from baseline (start of
blinded treatment) to the end of a 12 weeks' double-blind treatment period based on patient
diaries. Patients recorded their motor symptoms in half-hour blocks as OFF, ON without
dyskinesia, ON without troublesome dyskinesia, or sleeping using the Hauser Parkinson's
Disease home diary.
Key secondary Endpoints (tested hierarchically):
- Change in time spent "ON without troublesome dyskinesia"
- Patient Global Impression of Change
Other Endpoints:
- Percentage of patients with response to therapy, defined as a mean OFF time reduction of
at least 2 hours
- Change in oral levodopa and levodopa equivalent dose
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
| Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
| Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
| Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
| Active, not recruiting |
NCT04006210 -
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
|
Phase 3 | |
| Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
| Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
| Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
| Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
| Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
| Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
| Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
| Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
| Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
| Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
| Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
| Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
| Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
| Terminated |
NCT02894567 -
Evaluation of Directional Recording and Stimulation Using spiderSTN
|
N/A | |
| Completed |
NCT02939391 -
A Study of KW-6356 in Subjects With Early Parkinson's Disease
|
Phase 2 |