Post-hoc analysis of DWN12088: Comparative analysis between fasting period and adverse event incidences in Healthy subjects

Author(s):  
Min Young Park ◽  
Junga Heo ◽  
Yukyung Kim ◽  
Jumi Han
2008 ◽  
Vol 66 (2b) ◽  
pp. 336-340 ◽  
Author(s):  
Clayton Amaral Domingues ◽  
Sergio Machado ◽  
Emerson Garcia Cavaleiro ◽  
Vernon Furtado ◽  
Mauricio Cagy ◽  
...  

The present study aimed at investigating changes in behavior (shooting precision) and electrophysiological variables (absolute alpha power) during the motor learning of practical pistol shooting. The sample was composed of 23 healthy subjects, right-handed, male, between 18 and 20 years of age. The task consisted of four learning blocks. A One-way ANOVA with repeated measures and a post hoc analysis were employed to observe modifications on behavioral and electrophysiological measures (p<0.05). The results showed significative differences between blocks according to motor learning, and a significant improvement in shooting's accuracy from both blocks. It was observed a decrease in alpha power in all electrodes examined during task execution when compared with baseline and learning control blocks. The findings suggest that alpha power decreases as the function of the motor learning task when subjects are engaged in the motor execution.


2020 ◽  
Vol 79 (4) ◽  
pp. 525-528 ◽  
Author(s):  
Felix Eckstein ◽  
Jeffrey L Kraines ◽  
Aida Aydemir ◽  
Wolfgang Wirth ◽  
Susanne Maschek ◽  
...  

ObjectivesIn the phase II FGF-18 Osteoarthritis Randomized Trial with Administration of Repeated Doses (FORWARD) study, sprifermin demonstrated cartilage modification in the total femorotibial joint and in both femorotibial compartments by MRI in patients with knee osteoarthritis. Here, we evaluate whether sprifermin reduces cartilage loss and increases cartilage thickness, independent of location.MethodsPatients were randomised 1:1:1:1:1 to three once-weekly intra-articular injections of 30 µg sprifermin every 6 months (q6mo); 30 µg sprifermin every 12 months (q12mo); 100 µg sprifermin q6mo; 100 µg sprifermin q12mo; or placebo. Post-hoc analysis using thinning/thickening scores and ordered values evaluated femorotibial cartilage thickness change from baseline to 24 months independent of location. Changes were indirectly compared with those of Osteoarthritis Initiative healthy subjects.ResultsThinning scores were significantly lower for sprifermin 100 µg q6mo versus placebo (mean (95% CI) difference: 334 µm (114 to 554)), with a cartilage thinning score similar to healthy subjects. Thickening scores were significantly greater for sprifermin 100 µg q6mo, 100 µg q12mo and 30 µg q6mo versus placebo (mean (95% CI) difference: 425 µm (267 to 584); 450 µm (305 to 594) and 139 µm (19 to 259), respectively) and more than doubled versus healthy subjects.ConclusionsSprifermin increases cartilage thickness, and substantially reduces cartilage loss, expanding FORWARD primary results.Trial registration numberNCT01919164.


2018 ◽  
Vol 89 (6) ◽  
pp. A23.1-A23 ◽  
Author(s):  
Terence J O’Brien ◽  
Francesco Bibbiani ◽  
Anna Patten ◽  
Antonio Laurenza ◽  
Betsy Williams

IntroductionPerampanel is approved for adjunctive treatment of partial seizures, with or without secondarily generalised seizures, and primary generalised tonic-clonic (PGTC) seizures in epilepsy patients aged ≥12 years. Perampanel is also approved for monotherapy use for partial seizures in the US. This post hoc analysis assessed the effects of the most common concomitant Baseline antiepileptic drugs (AEDs) on discontinuation rates and treatment-emergent adverse event (TEAE) incidence during adjunctive treatment with perampanel in patients (aged ≥12 years) with idiopathic generalised epilepsy (IGE) and PGTC seizures in the open-label extension (OLEx) Phase of Study 332 (NCT02307578).MethodsPatients completing the double-blind study could receive perampanel (≤12 mg/day) during the OLEx (6 week blinded Conversion Period;≤136 weeks’ Maintenance). Here, we report results for perampanel >4–8 mg/day and >8–12 mg/day.ResultsMost common concomitant Baseline AEDs were valproic acid (n=55), lamotrigine (n=53), levetiracetam (n=37), topiramate (n=21) and zonisamide (n=12); patients may have received >1 of these Baseline AEDs. The most common reasons for discontinuing were adverse event(s) (AE), ‘other’ and patient choice. Lamotrigine: patient choice, n=6/34 (>4–8 mg/day); AE/‘other’, both n=3/19 (>8–12 mg/day). Levetiracetam: patient choice, n=5/27 (>4–8 mg/day); AE, n=2/10 (>8–12 mg/day). Topiramate: ‘other’, n=3/15 (>4–8 mg/day); AE/‘other’, both n=1/6 (>8–12 mg/day). Valproic acid: patient choice, n=6/38 (>4–8 mg/day); ‘other’, n=4/17 (>8–12 mg/day). Zonisamide: patient choice/‘other’, both n=2/10 (>4–8 mg/day); no discontinuations (>8–12 mg/day). Patient-reported TEAEs ranged from: 88.2% (lamotrigine) to 93.3% (topiramate) for perampanel >4–8 mg/day, and 70.6% (valproic acid) to 100.0% (topiramate and zonisamide) for perampanel >8–12 mg/day. The most common TEAE was dizziness.ConclusionIn this post hoc analysis, primary reasons for discontinuation and TEAE incidence differed between the most common Baseline AED subgroups and perampanel dose range, although TEAE types were similar. These data provide additional information on the safety of adjunctive perampanel in patients with IGE.Study supportEisai Inc.


2018 ◽  
Vol 24 ◽  
pp. 80-81
Author(s):  
Konstantinos Toulis ◽  
Krishna Gokhale ◽  
G. Neil Thomas ◽  
Wasim Hanif ◽  
Krishnarajah Nirantharakumar ◽  
...  

2018 ◽  
Vol 24 ◽  
pp. 51-52
Author(s):  
Vanita Aroda ◽  
Danny Sugimoto ◽  
David Trachtenbarg ◽  
Mark Warren ◽  
Gurudutt Nayak ◽  
...  

2004 ◽  
Vol 18 (1) ◽  
pp. 13-26 ◽  
Author(s):  
Antoinette R. Miller ◽  
J. Peter Rosenfeld

Abstract University students were screened using items from the Psychopathic Personality Inventory and divided into high (n = 13) and low (n = 11) Psychopathic Personality Trait (PPT) groups. The P300 component of the event-related potential (ERP) was recorded as each group completed a two-block autobiographical oddball task, responding honestly during the first (Phone) block, in which oddball items were participants' home phone numbers, and then feigning amnesia in response to approximately 50% of items in the second (Birthday) block in which oddball items were participants' birthdates. Bootstrapping of peak-to-peak amplitudes correctly identified 100% of low PPT and 92% of high PPT participants as having intact recognition. Both groups demonstrated malingering-related P300 amplitude reduction. For the first time, P300 amplitude and topography differences were observed between honest and deceptive responses to Birthday items. No main between-group P300 effects resulted. Post-hoc analysis revealed between-group differences in a frontally located post-P300 component. Honest responses were associated with late frontal amplitudes larger than deceptive responses at frontal sites in the low PPT group only.


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