scholarly journals Zonisamide improves axial symptoms in dementia with Lewy bodies with parkinsonism: Post hoc analysis of clinical trials

2021 ◽  
pp. 100384
Author(s):  
Yoshio Tsuboi ◽  
Kenji Kochi ◽  
Hidenori Maruyama ◽  
Yuji Matsumoto
Keyword(s):  
Clinical Trials ◽  
Dementia With Lewy Bodies ◽  
Lewy Bodies ◽  
Post Hoc Analysis ◽  
Axial Symptoms ◽  
Post Hoc

scholarly journals Efficacy and Safety of Zonisamide in Dementia with Lewy Bodies Patients with Parkinsonism: A Post Hoc Analysis of Two Randomized, Double-Blind, Placebo-Controlled Trials

2020 ◽  
pp. 1-11
Author(s):  
Kazuko Hasegawa ◽  
Kenji Kochi ◽  
Hidenori Maruyama ◽  
Osamu Konishi ◽  
Shunji Toya ◽  
...  
Keyword(s):  
Dementia With Lewy Bodies ◽  
Lewy Bodies ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Phase Ii And Iii ◽  
Previous Phase ◽  
Updrs Part

Background: Although previous phase II and III clinical trials conducted in Japan showed that zonisamide improved parkinsonism in patients with dementia with Lewy bodies (DLB), some differences in efficacy outcomes were observed between the trials. Objective: We aimed to further examine the efficacy and safety of zonisamide in DLB patients with parkinsonism in a post hoc analysis of pooled data from the previous phase II and III trials. Methods: Both trials featured a 4-week run-in period followed by a 12-week treatment period with a double-blind, placebo-controlled, parallel-group, randomized, multicenter trial design. In our pooled analysis, the primary outcome was the change in Unified Parkinson’s Disease Rating Scale (UPDRS) part III total score. Other outcomes included the changes in Neuropsychiatric Inventory-10 (NPI-10) and Mini-Mental State Examination (MMSE) scores, and the incidence of adverse events. Results: Zonisamide significantly decreased the UPDRS part III total and individual motor symptom scores but did not affect the NPI-10 or MMSE scores at week 12. There was no difference in the incidence of adverse events between the zonisamide and placebo groups except for decreased appetite, which had an increased frequency in the zonisamide 50 mg group compared with placebo. Conclusion: Our findings indicate that zonisamide improved parkinsonism with DLB without deterioration of cognitive function and BPSD.

Natural History of Patients Taking Rifaximin-α for Recurrent Hepatic Encephalopathy and Risk of Future Overt Episodes and Mortality: A Post-hoc Analysis of Clinical Trials Data

2016 ◽  
Vol 38 (5) ◽  
pp. 1081-1089.e4 ◽  
Author(s):  
Christian A. Bannister ◽  
James G. Orr ◽  
Alan V. Reynolds ◽  
Mark Hudson ◽  
Peter Conway ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hepatic Encephalopathy ◽  
Natural History ◽  
Post Hoc Analysis ◽  
History Of ◽  
Post Hoc

scholarly journals Estimation of the correlates of protection of the rVSVΔG-ZEBOV-GP Zaire ebolavirus vaccine: a post-hoc analysis of data from phase 2/3 clinical trials

2021 ◽  
Vol 2 (2) ◽  
pp. e70-e78 ◽  
Author(s):  
Rebecca F Grais ◽  
Stephen B Kennedy ◽  
Barbara E Mahon ◽  
Sheri A Dubey ◽  
Rebecca J Grant-Klein ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase 2 ◽  
Post Hoc Analysis ◽  
Correlates Of Protection ◽  
Zaire Ebolavirus ◽  
Post Hoc

25572 Impact of risankizumab on the duration of PASI90 achievement: A post hoc analysis of 4 phase III clinical trials

2021 ◽  
Vol 85 (3) ◽  
pp. AB62
Author(s):  
Mark G. Lebwohl ◽  
Ahmed M. Soliman ◽  
Hongbo Yang ◽  
Jessie Wang ◽  
Sarah H. Koenigsberg ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Post Hoc Analysis ◽  
Phase Iii Clinical Trials ◽  
Post Hoc

scholarly journals Advanced Intrahepatic Cholangiocarcinoma: Post Hoc Analysis of the ABC-01, -02, and -03 Clinical Trials

2019 ◽  
Author(s):  
Angela Lamarca ◽  
Paul Ross ◽  
Harpreet S Wasan ◽  
Richard A Hubner ◽  
Mairéad G McNamara ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Intrahepatic Cholangiocarcinoma ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials

2020 ◽  
Vol 08 (05) ◽  
pp. E628-E635
Author(s):  
Michael S. Epstein ◽  
Robert Benamouzig ◽  
Juha Halonen ◽  
Raf Bisschops
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Combined Treatment ◽  
Sulfate Solution ◽  
Lesion Detection ◽  
High Quality ◽  
Post Hoc Analysis ◽  
Colon Cleansing ◽  
Adenoma Detection ◽  
Post Hoc

Abstract Background and study aims Multiple neoplasia increase the risk of colorectal cancer. High-quality cleansing may improve adenoma detection. We assessed whether a new bowel preparation can improve colon cleansing and multiple lesion detection. Patients and methods This post hoc analysis of two randomized clinical trials in Europe and the US assessed the per study and combined cleansing efficacy of overnight split dosing with (preparation + clear fluids) 1 + 1 L polyethylene glycol (PEG) NER1006 versus 2 + 1 L PEG + ascorbate (2LPEG) or 1 + 2 L oral sulfate solution (OSS) combined. Treatment-blinded central readers assessed cleansing quality using the Harefield Cleansing Scale (HCS). Patients with full segmental scoring were included. HCS segmental scores 0–4 (high-quality = HCS 3–4) were analyzed for NER1006 versus 2LPEG/OSS. Mean number of polyps or adenomas per patient (MPP/MAP) was calculated for treatments in patients with at least one polyp or adenoma. Results In 1037 patients, NER1006 attained a greater rate of HCS 3 scores (29 % vs. 20 %; P < 0.001) and HCS 4 scores (20 % vs. 17 %; P = 0.007) versus 2LPEG/OSS. More polyps (678 versus 585) and adenomas (397 versus 331) were detected with NER1006 (N = 517) versus 2LPEG/OSS (N = 520). In all neoplasia-positive patients, with increasing minimal per-patient neoplasia multiplicity from 1 to 10, NER1006 numerically improved MPP (difference ± SE: 0.48 ± 0.24 to 3.89 ± 3.37) and MAP (0.47 ± 0.26 to 7.50 ± 9.00) versus 2LPEG/OSS. Conclusions Low-volume NER1006 enhances high-quality cleansing versus medium-volume 2LPEG or OSS, individually and when combined. NER1006 may consequently facilitate the detection of multiple neoplasia in patients.

Clinical Trials of Dementia With Lewy Bodies and Parkinson’s Disease Dementia

2012 ◽  
Vol 12 (5) ◽  
pp. 492-501 ◽  
Author(s):  
D. Aarsland ◽  
C. Ballard ◽  
A. Rongve ◽  
M. Broadstock ◽  
P. Svenningsson
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Dementia With Lewy Bodies ◽  
Lewy Bodies ◽  
Parkinson’S Disease Dementia
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