scholarly journals How Far Do the Complaints of Patients with Parkinson’s Disease Reflect Motor Fluctuation? Quantitative Analysis Using a Portable Gait Rhythmogram

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Hiroya Utsumi ◽  
Hiroo Terashi ◽  
Yohei Ishimura ◽  
Tomoko Takazawa ◽  
Yasuyuki Okuma ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Quantitative Analysis ◽  
Motor Fluctuation ◽  
Gait Disorders ◽  
Gait Disorder ◽  
New Device ◽  
The Times ◽  
Off Time ◽  
Normal Controls

In advanced-stage Parkinson’s disease (PD), motor fluctuation is a frequent and disabling problem. Assessment of motor fluctuation depends on patient’s subjective self-statement. We examined whether the subjective fluctuation matched the objective motor fluctuation defined by gait disorders. Using a new device, the portable gait rhythmogram, we recorded gait cadence and acceleration continuously over the 24-hour period in 54 patients with PD and 17 normal controls, for the quantitative evaluation of motor fluctuation. The patients were asked to estimate motor fluctuation every hour. In 44 of 54 patients, changes in the cadence were associated with simultaneous changes in acceleration. We examined the subjective fluctuation in these 44 patients who were confirmed to have motor fluctuation. Nineteen (82.7%) of 23 patients who felt no fluctuation showed distinct gait disorders. During off time, they walked with marked short or bradykinetic stepping. No matching changes were observed in either the cadence or acceleration in 11 (52.4%) of 21 patients who perceived motor fluctuation. No synchronization was noted in 30 (68.2%) of the 44 patients, between the times of subjectively assessed motor fluctuation and those of quantitative analysis of gait disorder. This discrepancy suggests that the objective continuous recording of the cadence and acceleration is necessary to understand motor fluctuation.

scholarly journals The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II

2021 ◽  
Vol 12 ◽  
Author(s):  
José-Francisco Rocha ◽  
Georg Ebersbach ◽  
Andrew Lees ◽  
Eduardo Tolosa ◽  
Joaquim J. Ferreira ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Wide Spectrum ◽  
Motor Fluctuation ◽  
Motor Fluctuations ◽  
Disease Course ◽  
Treatment Pathway ◽  
Levodopa Treatment ◽  
Post Hoc ◽  
Off Time

Introduction: Opicapone (OPC) was efficacious in reducing OFF-time in two pivotal trials in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations (BIPARK-I and -II). Post-hoc analyses of these trials evaluated the efficacy of OPC following pre-defined segmentation of the wide spectrum of motor fluctuations in PD.Methods: Data from matching treatment arms in BIPARK-I and -II were combined for the placebo (PLC) and OPC 50-mg groups, and exploratory post-hoc analyses were performed to investigate the efficacy of OPC 50 mg vs. PLC in subgroups of patients who were in “earlier” vs. “later” stages of both their disease course (e.g., duration of PD <6 years vs. ≥6 years) and levodopa treatment pathway (e.g., number of daily levodopa intakes <4 vs. ≥4). Efficacy variables included changes from baseline in absolute OFF-time and total ON-time.Results: The Full Analysis Set included 517 patients (PLC, n = 255; OPC 50 mg, n = 262). OPC 50 mg was significantly more effective than PLC in reducing OFF-time and increasing ON-time in the majority of subgroup analyses (p < 0.05). Moreover, patients in “earlier” stages of both their disease course and levodopa treatment pathway experienced numerically greater efficacy when using OPC 50 mg, in comparison with those in “later” stages.Conclusion: OPC 50 mg was efficacious over the whole trajectory of motor fluctuation evolution in PD patients. There was also a signal for enhanced efficacy in patients who were earlier vs. later in their disease course and levodopa treatment pathway.

scholarly journals Efficacy of Istradefylline, an Adenosine A2A Receptor Antagonist, as Adjunctive Therapy to Levodopa in Parkinson’s Disease: A Pooled Analysis of 8 Phase 2b/3 Trials

2021 ◽  
pp. 1-13
Author(s):  
Robert A. Hauser ◽  
Nobutaka Hattori ◽  
Hubert Fernandez ◽  
Stuart H. Isaacson ◽  
Hideki Mochizuki ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Receptor Antagonist ◽  
Repeated Measures ◽  
Pooled Analysis ◽  
Adenosine A2a Receptor ◽  
A2a Receptor ◽  
Adenosine A2a Receptor Antagonist ◽  
Adenosine A2a ◽  
Off Time

Background: Istradefylline is a selective adenosine A2A receptor antagonist for the treatment of patients with Parkinson’s disease (PD) experiencing OFF episodes while on levodopa/decarboxylase inhibitor. Objective: This pooled analysis of eight randomized, placebo-controlled, double-blind phase 2b/3 studies evaluated the efficacy and safety of istradefylline. Methods: Istradefylline was evaluated in PD patients receiving levodopa with carbidopa/benserazide and experiencing motor fluctuations. Eight 12- or 16-week trials were conducted (n = 3,245); four of these studies were the basis for istradefylline’s FDA approval. Change in OFF time as assessed in patient-completed 24-h PD diaries at Week 12 was the primary endpoint. All studies were designed with common methodology, thereby permitting pooling of data. Pooled analysis results from once-daily oral istradefylline (20 and 40 mg/day) and placebo were evaluated using a mixed-model repeated-measures approach including study as a factor. Results: Among 2,719 patients (placebo, n = 992; 20 mg/day, n = 848; 40 mg/day, n = 879), OFF hours/day were reduced at Week 12 at istradefylline dosages of 20 mg/day (least-squares mean difference [LSMD] from placebo in reduction from baseline [95%CI], –0.38 h [–0.61, –0.15]) and 40 mg/day (–0.45 h [–0.68, –0.22], p <  0.0001); ON time without troublesome dyskinesia (ON-WoTD) significantly increased. Similar results were found in the four-study pool (OFF hours/day, 20 mg/day, –0.75 h [–1.10, –0.40]; 40 mg/day, –0.82 h [–1.17, –0.47]). Istradefylline was generally well-tolerated; the average study completion rate among istradefylline-treated patients across all studies was 89.2%. Dyskinesia was the most frequent adverse event (placebo, 9.6%; 20 mg/day, 16.1%; 40 mg/day, 17.7%). Conclusion: In this pooled analysis, istradefylline significantly improved OFF time and ON-WoTD relative to placebo and was well-tolerated.

scholarly journals PARKINSON'S DISEASE AND SPIRITUALITY

2015 ◽  
Vol 86 (11) ◽  
pp. e4.190-e4
Author(s):  
Alasdair Coles ◽  
Clare Redfern
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Quantitative Analysis ◽  
Chronic Respiratory Disease ◽  
Religious Community ◽  
Religious Support ◽  
Healthy Controls ◽  
Spiritual Experiences ◽  
Multidimensional Measure ◽  
Reduced Mobility

A limited literature suggests that people with Parkinson's disease have reduced religious beliefs, practices and experiences, compared to normal healthy controls. But we reasoned these results may be confounded by reduced mobility and social isolation associated with Parkinson's disease. So, we recruited a cohort of 42 Parkinson's patients and 39 controls with chronic respiratory disease, non-neurological autoimmune disease or rheumatological problems. Each subject was examined twice, 12 months apart and assessed on validated scales of handicap and impairment, with spirituality measured by the modified Brief Multidimensional Measure of Religiousness/Spirituality (BMMRS), an abbreviated Hood Mysticism Scale, and the Cloninger Transcendance Inventory.As expected, the Parkinson's group showed a greater decline in mobility and cognitive function over 12 months, compared to controls yet their religiosity scores were undiminished. Quantitative analysis showed significantly increased positive spiritual experiences in the Parkinson's group (p=0.04) relative to controls. “Religious support”, a proxy for involvement in a religious community, was maintained despite decreasing mobility. Qualitative accounts indicated that faith and spirituality were maintained in those patients with PD for whom it was important at baseline. We identified no aspect of faith that was reduced by degeneration of basal ganglia pathways.

scholarly journals Continuous Subcutaneous Levodopa Delivery for Parkinson’s Disease: A Randomized Study

2020 ◽  
pp. 1-10
Author(s):  
C. Warren Olanow ◽  
Alberto J. Espay ◽  
Fabrizio Stocchi ◽  
Aaron L. Ellenbogen ◽  
Mika Leinonen ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Randomized Study ◽  
Preliminary Evidence ◽  
Common Adverse Event ◽  
Open Label ◽  
Open Label Study ◽  
Dosing Regimens ◽  
Optimized Treatment ◽  
Off Time

Background: ND0612 is a continuous, subcutaneous levodopa/carbidopa delivery system in development for patients with Parkinson’s disease (PD) experiencing motor fluctuations Objective: Evaluate the efficacy and safety of two ND0612 dosing regimens in patients with PD. Methods: This was a 28-day open-label study (NCT02577523) in PD patients with ≥2.5 hours/day of OFF time despite optimized treatment. Patients were randomized to treatment with either a 24-hour infusion (levodopa/carbidopa dose of 720/90 mg) or a 14-hour ‘waking-day’ infusion (levodopa/carbidopa dose of 538/68 mg plus a morning oral dose of 150/15 mg). In-clinic assessments of OFF time (primary endpoint) and ON time with or without dyskinesia were determined by a blinded rater over 8 hours (normalized to 16 hours). Results: A total of 38 patients were randomized and 33 (87% ) completed the study. Compared to baseline, OFF time for the overall population was reduced by a least squares (LS) mean[95% CI] of 2.0[– 3.3, – 0.7] hours (p = 0.003). ON time with no/mild dyskinesia was increased from baseline by a LS mean of 3.3[2.0, 4.6] hours (p <  0.0001), and ON time with moderate/severe dyskinesia was reduced by a LS mean of 1.2[– 1.8, – 0.5] hours (p≤0.001). Reduction in OFF time was larger in the 24-hour group (– 2.8[– 4.6, – 0.9] hours; p = 0.004) than in the 14-hour group (– 1.3[– 3.1, 0.5] hours; p = 0.16). Complete resolution of OFF time was observed in 42% (n = 8) of patients in the 24-hour group. Infusion site reactions were the most common adverse event. Conclusion: This study demonstrates the feasibility and safety of continuous subcutaneous delivery of levodopa as a treatment for PD and provides preliminary evidence of efficacy.

scholarly journals Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Cindy Zadikoff ◽  
Werner Poewe ◽  
James T. Boyd ◽  
Lars Bergmann ◽  
Horia Ijacu ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Rating Scale ◽  
Phase Iii ◽  
High Dose ◽  
Double Blind Study ◽  
Dosage Group ◽  
Continuous Administration ◽  
Advanced Parkinson’S Disease ◽  
Off Time

Background. Levodopa-carbidopa intestinal gel (LCIG) provides continuous levodopa administration and clinical benefits to patients with advanced Parkinson’s disease (PD). This report evaluates long-term safety and efficacy of high-dose LCIG in PD patients. Methods. Data were collected from several prospective, phase III clinical studies and an observational registry. The phase III program (N = 412) included four multicenter studies: a 12-week, randomized, double-blind study and three open-label studies extending ≥12 months. GLORIA (N = 375) was a 24-month, multicountry, observational registry. LCIG safety (adverse effects (AEs)/adverse drug reactions (ADRs)) and efficacy (modified Unified Parkinson’s Disease Rating Scale (UPDRS) part IV item 32 and 39 scores for “On” time with dyskinesia and “Off” time) were assessed in patients who received ≥2000 mg/day vs <2000 mg/day LCIG. Results. A total of 72 of 412 (17.5%) patients required dosages ≥2000 mg/day LCIG in the phase III program and 47 of 375 (12.5%) patients in GLORIA. Baseline demographics and disease severity were similar between dosage groups with more men in the high-dosage group. Compared with the <2000 mg/day dosage group, patients requiring ≥2000 mg/day LCIG had higher rates of AEs/ADRs including polyneuropathy; improvements in “Off” time and discontinuations due to AEs were similar between dosage groups and lower for discontinuations due to ADRs reported in GLORIA. Conclusions. Patients who require ≥2000 mg/day LCIG exhibited a safety profile comparable to the established safety/tolerability of LCIG with similar clinical improvements. Higher AEs were noted but within what is accepted for LCIG. Continuous administration of LCIG is beneficial to advanced PD patients who require very high doses of levodopa.

Sign in / Sign up

Export Citation Format

Share Document