Clinical trials: Motor Fluctuations
Parkinson Disease
Lisuride Patch to Treat Parkinson's Disease
This study will evaluate the effectiveness of a skin patch formulation of the dopamine agonist Lisuride in controlling parkinsonian symptoms and dyskinesias (involuntary movements) caused by levodopa.
- Trial name
- NCT00089622
- Testing
- Intravenous Levodopa, Lisuride Transdermal System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
PARKINSON DISEASE (Disorder)
Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease
This study is a Phase III multicentric randomized controlled trial with parallel group design and waiting list in patients that have an indication to undergo intestinal L-Dopa + entacapone (Lecigon®) under the existing indication…
- Trial name
- INITIATE-LECIG (NCT07151378)
- Testing
- LECIG (levodopa, carbidopa, entacapone intestinal gel), Best oral medication
- Where
- 7 sites in Germany
- Volunteers
- 150 people
- Sponsor
- University Hospital Tuebingen
Parkinson Disease
OpicApone Sleep dISorder
The aim of this study is to To investigate in an exploratory manner the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's…
- Trial name
- OASIS (NCT04986995)
- Testing
- Opicapone
- Where
- Portugal
- Volunteers
- 22 people
- Sponsor
- Bial - Portela C S.A.
Parkinson's Disease
Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients
Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons.
- Trial name
- NCT00865579
- Testing
- Safinamide
- Where
- Romania
- Volunteers
- 964 people
- Sponsor
- Newron Pharmaceuticals SPA
Parkinson's Disease
Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale in Parkinson's Disease
This study focuses on neuropsychiatric fluctuations (NPF) in Parkinson's disease. Due to the lack of specific assessment tools, we developed the Neuropsychological Fluctuations Scale (NFS), a 20-item questionnaire.
- Trial name
- EFN-RETEST (NCT06701955)
- Testing
- Questionnaire and Physical Exam
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Grenoble
Mild Cognitive Impairment (MCI), Early Stages of Cognitive Decline
Mild Cognitive Impairment Community Screening and Early Intervention Via Stem Cell Therapy and Wearable Brain Computer Interface Device.
This study aims to evaluate the efficacy of community-based early detection and targeted interventions, including stem cell therapy and wearable non-invasive brain-computer interface (BCI) devices, for Mild Cognitive Impairment…
- Conditions
- Mild Cognitive Impairment (MCI), Early Stages of Cognitive Decline, Alzheimer's Disease Dementia, Alzheimer's Disease Diagnosis
- Trial name
- MCITestCare (NCT07214974)
- Testing
- Structured wellness care, Wearable brain-computer interface devices, Stem Cell Therapy - Experimental
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Noah Tech, Corp.
Parkinson's Disease
Parkinson's KinetiGraph as Tool for DBS Eligibility Assessment
The purpose of the study is to investigate the feasibility of using the commercially available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor fluctuations in Parkinson's Disease (PD) patients.
- Trial name
- KITE (NCT02509325)
- Testing
- Parkinson's Kinetigraph
- Where
- 2 sites in France, Germany
- Volunteers
- 38 people
- Sponsor
- MedtronicNeuro
Advanced Parkinson's Disease
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.
- Trial name
- NCT00660387
- Testing
- Levodopa carbidopa intestinal gel (LCIG), Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets, CADD-Legacy® 1400 ambulatory infusion pump
- Where
- 14 sites in United States, New Zealand
- Volunteers
- 35 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Parkinson Disease
Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial
When Parkinson Disease is mild, it responds well to treatment with drugs (L-Dopa and dopamine antagonists). However, as the disease progresses, the effect of the drugs diminishes and lasts for a shorter time (wearing-off), which…
- Trial name
- MoMoPa-EC (NCT04176302)
- Testing
- Parkinson Holter, Motor fluctuations diary, Traditional clinical practice
- Where
- 43 sites in Spain
- Volunteers
- 173 people
- Sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
Advanced Parkinson's Disease
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment…
- Trial name
- NCT00660673
- Testing
- Levodopa-Carbidopa Intestinal Gel (LCIG), CADD-Legacy® 1400 ambulatory infusion pump, Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 262 people
- Sponsor
- AbbVie
Idiopathic Parkinson's Disease
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an…
- Trial name
- SPAN-PD™ (NCT02240030)
- Testing
- CVT-301 Low Dose, CVT-301 High Dose
- Where
- 74 sites in United States, Canada and 3 more
- Volunteers
- 351 people
- Sponsor
- Acorda Therapeutics
Parkinson Disease
Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients
This is a phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa (LD/CD) vs.semi-continuous intra-oral administration of…
- Trial name
- LDCD-001 (NCT02763137)
- Testing
- Standard LD/CD, Semi continuous intra-oral administration of LD/CD
- Where
- Italy
- Volunteers
- 18 people
- Sponsor
- IRCCS San Raffaele Roma
Parkinson Disease, Motor Disorder
BTRX-246040 Study in Participants With Parkinson's Disease With Motor Fluctuations
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and efficacy of BTRX-246040 in participants with Parkinson's Disease who have motor fluctuations and predictable early morning off periods.
- Trial name
- NCT03608371
- Testing
- BTRX-246040
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- BlackThorn Therapeutics, Inc.
PARKINSON DISEASE (Disorder), Pain
Safinamide vs Placebo for Pain in Patients With Parkinson's Disease and Motor Fluctuations
This is a Phase III, single-center, randomized, double-blind, placebo-controlled clinical trial designed to investigate the superiority of safinamide compared to a placebo in reducing Parkinson's Disease (PD)-related pain.
- Conditions
- PARKINSON DISEASE (Disorder), Pain, Pain Management, Parkinson Disease (PD)
- Trial name
- SAVE PAIN (NCT07761936)
- Testing
- Safinamide
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Universita di Verona
Parkinson's Disease With Wearing-off Motor Fluctuations
Efficacy and Safety of Opicapone in Clinical Practice
The purpose of this study is to evaluate the change in subject's condition according to the Investigator's Global Assessment of Change after three months of treatment with 50 mg opicapone once daily in a heterogeneous patient…
- Trial name
- OPTIPARK (NCT02847442)
- Testing
- BIA 9-1067, levodopa/dopa decarboxylase inhibitor
- Where
- Germany
- Volunteers
- 518 people
- Sponsor
- Bial - Portela C S.A.
Parkinson Disease (PD)
The Effect of Amantadine as add-on Therapy for Motor Fluctuations in Advanced Parkinson's Disease: a Randomized Double-blinded Placebo-controlled Trial
Motor fluctuations are identified as the most challenging symptoms by parkinson disease patients. A recent post-hoc analysis of ADS-5012 trials (new formulation of ER Amantadine), revealed a significant improvement in OFF-time.
- Trial name
- AMANT-OFF (NCT06817200)
- Testing
- Amantadine (100mg) as add on therapy.
- Where
- France
- Volunteers
- 132 people
- Sponsor
- University Hospital, Toulouse
Parkinson Disease
Dopaminergic restauratIon by intraVEntriculaire Administration
Prospective monocentric randomized controlled open-label proof-of-concept study in cross-over of two 1-month periods and a long-term follow-up period not to exceed September 30, 2023, with 2 groups: Intracerebroventricular…
- Trial name
- DIVE (NCT04332276)
- Testing
- A-dopamine, optimized oral treatment
- Where
- France
- Volunteers
- 12 people
- Sponsor
- University Hospital, Lille
Parkinson's Disease
A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to…
- Trial name
- NCT01171313
- Testing
- XP21279 and carbidopa (experimental), Sinemet (comparator)
- Where
- 12 sites in United States
- Volunteers
- 35 people
- Sponsor
- XenoPort, Inc.
Parkinson's Disease
Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease
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…
- Trial name
- TOLEDO (NCT02006121)
- Testing
- Apomorphine hydrochloride
- Where
- 20 sites in Austria, Denmark and 5 more
- Volunteers
- 107 people
- Sponsor
- Britannia Pharmaceuticals Ltd.
Parkinson Disease
A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the effects of 100 mg safinamide, administered orally once daily (OD), in Chinese Parkinson's disease (PD) patients, experiencing…
- Trial name
- NCT03881371
- Testing
- Safinamide
- Where
- 31 sites in China
- Volunteers
- 307 people
- Sponsor
- Zambon SpA