Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease...
Parkinson's DiseaseThe purpose of this study is to assess the safety, feasibility, and efficacy of intravenous allogeneic bone marrow-derived mesenchymal stem cell (MSC) therapy for idiopathic Parkinson's disease (iPD).
Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's...
Parkinson DiseaseThis study will be conducted in three parallel groups receiving oxycodone, levodopa or placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian treatment. As this study focuses on chronic central neuropathic pain caused by PD, the effects of study treatments will be evaluated after a 10-week treatment period
A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's...
Parkinson's DiseaseThis is a multicenter, parallel-group, rater-blinded, randomized clinical study in subjects with advanced PD investigating the efficacy, PK, safety and tolerability of continuous SC infusion of 2 dosing regimens of ND0612H, a solution of LD/CD delivered via a pump system as a continuous SC infusion, compared to standard oral LD/CD. After screening, subjects will undergo 1 day of standard oral LD/CD inpatient dosing followed by 2 days of inpatient treatment with 1 of 2 randomly allocated (1:1 randomization ratio) dosing regimens of ND0612H continuous SC infusion. Subjects will then continue on a maintenance dose of the assigned ND0612H dosing regimen for the next 25 days. A safety visit will be performed 4 weeks after the last SC administration of the study drug for a total of about 2.5 months of participation for each subject enrolled into the trial.
Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease
ParkinsonParkinson's disease (PD) is one of the most common neurodegenerative diseases, with a higher prevalence in the elderly. Levodopa induced dyskinesias (LID) are a major motor complications that impair quality of life for patients with PD. The mechanisms of these dyskinesias remain unclear, but several hypotheses have been put forward: non continuous, pulsatile stimulation of dopaminergic receptors, or alterations of other neurotransmitters within the motor striatum such as glutamate and serotonin. Few strategies are now available to treat severe LID: Medications: reduction of dopaminergic treatment, addition of amantadine, Functional neurosurgery. The purpose of this study is to investigate the efficacy of buspirone in PD patients suffering from dyskinesias. The role of serotonin in the occurrence of LID was recently demonstrated in transplant PD patients and a test double-blind, single dose was achieved. Following administration of 10 mg oral buspirone, a 5HT1A agonist, LID were clearly improved. A antidyskinetic effect of buspirone had already been reported in 1991 and 1994, but identification of buspirone as a serotonin receptor agonist has been reported more recently. This trial is aimed at (1) validate the serotoninergic hypothesis of hyperkinetic levodopa induced dyskinesias (LID) in Pakinson's disease patients, (2) evaluate, in a phase 3 trial, the motor efficacy of buspirone to improve LID vs placebo, (3) look at a possible dose/effect relationship and (4) check the hypothesis of a better therapeutic ratio using the association of buspirone and amantadine instead than a single drug.
Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
Sleep DisordersPhysical ActivityWhole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional. The science behind the therapeutic effects of WBPA still remains largely unknown. The investigators are observing how WBPA may impact on sleep and activity in individuals with Parkinson's disease.
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
Parkinson's DiseaseDysphagia1 moreCurrently, there are no efficacious behavioral treatment approaches to address uncompensated aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD). This is of particular public health concern given that aspiration pneumonia is the leading cause of death in persons with PD. The overarching aim of the proposed study is to determine the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate the results will lead to reductions in the risks associated with airway protective deficits.
A Study of KW-6356 in Subjects With Early Parkinson's Disease
Parkinson's DiseaseThe primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.
Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics...
Parkinson DiseaseTo investigate the effect of rising oral single-doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of immediate release levodopa/carbidopa 100/25 mg (Sinemet® 100/25) or with a single-dose of Sinemet® 100/25 plus a single-dose of entacapone (Comtan®) 200 mg and to assess the tolerability and safety of rising single oral doses of BIA 6-512 when administered in combination with a single-dose of Sinemet® 100/25 or with a single-dose of Sinemet® 100/25 plus a single-dose of Comtan® 200 mg.
Instrumental or Physical-Exercise Rehabilitation of Balance in Parkinson's Disease? (IPER-PD)
Parkinson's DiseaseRehabilitationWe hypothesized that rehabilitation specifically addressing balance in Parkinson ́s disease patients might improve not only balance, but locomotion as well. Two balance training protocols (standing on a moving platform, and traditional balance exercises) were compared by assigning patients to two groups: moving platform (n=15) and balance exercises (n=17). Platform moved periodically in antero-posterior, latero-lateral and oblique direction, with and without vision in different trials. Balance exercises were based on Otago Exercise Program. Both platform and exercises sessions were administered from easy to difficult. Outcome measures were: a) balancing behaviour, assessed both by index of stability (IS) on platform and by Mini-BESTest, b) gait, assessed both by baropodometry and by Timed Up and Go (TUG) test. Falls Efficacy Scale-International (FES-I) and Parkinson's Disease Questionnaire (PDQ-8) were administered. Both groups exhibited better balance control, as assessed both by IS and by Mini-BESTest. Gait speed at both baropodometry and TUG also improved in both groups. Scores of FES-I and PDQ-8 showed a marginal improvement. A four-week treatment featuring no gait training, but focussed on challenging balance tasks produces considerable gait enhancement in mildly to moderately affected patients. Walking problems in PD depend on postural instability and are successfully relieved by appropriate balance rehabilitation.
Dose Escalation Study of Cu(II)ATSM in Parkinson's Disease
Parkinson DiseaseMulticenter, open-label dose-escalation study