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2.271 DEVELOPMENT OF INHALED APOMORPHINE FOR PATIENTS WITH FLUCTUATING PARKINSON'S DISEASE: DOSE-FINDING RESULTS

2.271 DEVELOPMENT OF INHALED APOMORPHINE FOR PATIENTS WITH FLUCTUATING PARKINSON'S DISEASE: DOSE-FINDING RESULTS Tuesday, 13 December 2011 / Parkinsonism and Related Disorders 18S2 (2012) S81–S159 S133 showed that safinamide 100 mg/day improved DRS scores in patients with more severe dyskinesia at baseline. Study supported by: Newron/Merck Serono S.A. – Geneva. 2.269 SAFINAMIDE AS ADD-ON TO LEVODOPA IN PARKINSON’S DISEASE WITH MOTOR FLUCTUATIONS MAY IMPROVE RESPONDER RATES VERSUS PLACEBO DURING LONG-TERM TREATMENT R. Anand1 , C. Meshram2 , J. Szasz3 , M. Bhatt4 , R. Guiliani5 , E. Forrest5 , V. Lucini5 , for the Study 018 Investigators. 1 APC AG, St Moritz, Switzerland; 2 Brain and Mind Institute, Nagpur, India; 3 Emergency County Hospital, Targu Mures, Romania; 4 Jaslok Hospital & Research Centre, Mumbai, India; 5 Newron Pharmaceuticals SpA, Bresso, Italy Objective: To determine the clinical relevance of the long-term benefits of safinamide, an a-aminoamide with dopaminergic and non-dopaminergic mechanisms, as add-on to levodopa. Methods: Previous analyses from Study 018 (n = 544), an 18-month, double-blind, placebo-controlled extension to Study 016 (6 months; n = 669), which evaluated safinamide (50 or 100 mg/day) added to levodopa in patients with Parkinson’s disease (PD) and motor fluctuations despite optimized therapy, showed that safinamide 100 mg/day had benefits on ON and OFF time, UPDRS Part II/III/IV, PDQ-39, and GRID HAM-D scores, but no significant effect on Dyskinesia Rating Scale (DRS) scores versus placebo. The present analysis was performed to determine the clinical relevance of these effects by evaluating responder rates. A hierarchical testing procedure was implemented: if the primary endpoint (change in DRS scores) was not met, key secondary endpoints were of exploratory nature only. Results: After 24 months, safinamide improved responder rates for a number of evaluations, including increase in ON time and decrease in OFF time with no worsening of troublesome dyskinesia (placebo [n = 222] 39.2%, 50 mg/day [n = 223] 45.3% [p = 0.1710] and 100 mg/day [n = 224] 49.6% [p = 0.0100]), and for ≥30% improvement in UPDRS Part III with no worsening in UPDRS Parts II or IV (placebo 21.6%, 50 mg/day 27.4% [p = 0.1002] and 100 mg/day 30.8% [p = 0.0059]). Discussion: Two-year treatment with safinamide in midlate PD patients with motor fluctuations despite optimized antiparkinsonian therapy was associated with improvements in responder rates that may be clinically important. Study supported by: Newron/Merck Serono S.A. – Geneva 2.270 BUPROPION ON FREEZING OF GAIT IN PARKINSON’S DISEASE Y.S. Park1 , W.C. Kim2 . 1 Dept.of Neurosurgery, 2 Dept.of Neurology, CHA Bundang Medical Center, CHA University, Seongnam-si, Republic of Korea Objective: To evaluate effects of bupropion on freezing of gait (FOG) in patients with idiopathic Parkinson’s disease (PD). Background: FOG is one of the most disabling problems in PD. The underlying pathophysiology of FOG is not understood completely yet. Because of poor responsiveness of FOG to dopamine replacement treatment, it is widely accepted that nondopaminergic neurotransmitters associated with pathophysiology of FOG in PD. Bupropion, a norepinephrine-dopamine reuptake inhibitor, seems to be a reasonable choice for the treatment of FOG from a theoretical point of view. Methods: PD patients who showed FOG on examination while best “on” phase were included. We performed an open-label 12-week trial. Treatment with bupropion was initiated with 150 mg/day, and increased up to 300 mg/day the next week. This was followed by a 10-week fixed-dose maintenance phase, during which all the patients were maintained on bupropion at 300 mg/day. Enrolled participants were evaluated with the Gait and Balance Scale (GABS) score before and after 12-week bupropion treatment. Results: Nine PD patients with FOG were enrolled prospectively. All patients showed disabling FOG in spite of appropriate dose of dopamine treatment. The mean GABS total score was reduced after the 12-week trial (30.4±3.5) compared with the baseline (34.5±5.0), but did not reach the statistical significance. Conclusions: Bupropion was not efficacious for the treatment of FOG in patients with PD. Large, double-blind, placebo-controlled, randomized trials may be helpful to show the efficacy of bupropion on FOG in PD. 2.271 DEVELOPMENT OF INHALED APOMORPHINE FOR PATIENTS WITH FLUCTUATING PARKINSON’S DISEASE: DOSE-FINDING RESULTS D. Grosset1 , K. Grosset1 , F. Morgan2 , Inhaled Apomorphine Study Group. 1 Neurology, Inst of Neurol Sciences, Glasgow, 2 Vectura Group plc, Chippenham, UK Background: Subcutaneous apomorphine injection is established as an intermittent treatment for OFF periods in Parkinson’s disease (PD). Clinical dose ranging of a rapidly acting and non-invasive inhaled apomorphine has been conducted. Methods: Inhaled apomorphine was tested in two separate randomised, double-blind, placebo-controlled, dose-ascending Phase 2 clinical studies until efficacy or adverse events occurred. Response to in-clinic doses of 1.5 to 4.0 mg (Study 1) and 1.5 to 4.5 mg (Study 2) was compared to a Levodopa challenge test. Outpatient testing was performed (Study 2) with changes in OFF and ON time measured. Results: 102 patients received study treatment, at an approximate 2.5:1 active: placebo ratio. Rapidly absorbed apomorphine (tmax of 2 minutes) resulted in therapeutic benefit 5–10 minutes post inhalation with some subjects converting to the ON state 1 minute post dose. In-clinic UPDRS 3 reduction was significantly greater for apomorphine than placebo in both studies: Study 1 treatment difference 11.6 points (95% confidence interval (CI) 2.3–20.9, p = 0.016; Study 2 treatment difference 8.4 points, CI 1.2–15.5, p = 0.023. Study 2 at-home OFF time reduction for apomorphine was greater than placebo (100.5 minutes, 95% CI −12.0–212.9) but was not statistically significant (p = 0.078). Tolerability was good; adverse events were consistent with dopaminergic stimulation (nausea, blood pressure change). Only 4 patients ascended to the 4.5 mg dose, at which additional benefit was minimal and adverse events were more frequent. Conclusion: Inhaled apomorphine showed promising efficacy, safety and tolerability at doses between 1.5 and 3.5 mg. 2.272 THE TREATMENT OF PAINFUL DIAPHRAGMATIC DYSTONIA IN IDIOPATHIC PARKINSON’S DISEASE WITH APOMORPHINE C.E. Pollock, A. Ross Russell, M. Silva. Neurology, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK Case report: A 46 year old male was diagnosed as having Idiopathic Parkinson’s Disease. He responded well initially to Pramipexole, Madopar, Stalevo and Selegiline with the emergence of dyskinesias and wearing off six years later. However, eight years after diagnosis he developed intermittent episodes of painful dyspnoea related to off phases. No other chest pathology was identified. The relationship to dopaminergic medication suggested a diagnosis of diaphragmatic dystonia. Manipulation of oral PD medication was ineffective but there was a clear and significant improvement following treatment with subcutaneous apomorphine. Quality of life was significantly improved. Conclusion: Apomorphine can be an effective way of treating painful diaphragmatic dystonia in PD. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Parkinsonism & Related Disorders Elsevier
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