open label phase
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2022 ◽  
Vol 162 ◽  
pp. 161-169
Sophie Cousin ◽  
Coralie Cantarel ◽  
Jean-Philippe Guegan ◽  
Thibault Mazard ◽  
Carlos Gomez-Roca ◽  

Haematologica ◽  
2022 ◽  
Carol Moreno ◽  
Richard Greil ◽  
Fatih Demirkan ◽  
Alessandra Tedeschi ◽  
Bertrand Anz ◽  

iLLUMINATE is a randomized, open-label phase 3 study of ibrutinib plus obinutuzumab (n=113) versus chlorambucil plus obinutuzumab (n=116) as first-line therapy for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. Eligible patients were aged ≥65 years, or

2021 ◽  
Riccardo Bertolo ◽  
Chiara Cipriani ◽  
Matteo Vittori ◽  
Marco Carilli ◽  
Francesco Maiorino ◽  

Abstract Background: Several studies described post-operative irritative symptoms after laser enucleation of prostate, sometimes associated with urge incontinence, probably linked to laser-induced prostatic capsule irritation, and potential for lower urinary tract infections We aimed to evaluate the efficacy of a suppository based on Phenolmicin P3 and Bosexil (Mictalase®) in control of irritative symptoms in patients undergoing thulium laser enucleation of prostate (ThuLEP).Methods: In this single-center, prospective, randomized, open label, phase-III study, patients with indication to ThuLEP were enrolled (Dec2019-Feb2021 - Institutional ethics committee STS CE Lazio approval no.1/N-726 - NCT05130918). The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Mictalase® suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive Mictalase® (“controls”). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering IPSS+QoL questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.Results: 111 patients were randomized: 56 in Group A received Mictalase®. Baseline and perioperative data were comparable. At 15-days, no significant differences were found in terms of IPSS+QoL scores and urinalysis parameters. A significant difference in the rate of positive urine cultures favored Group A (p=0.04). At 30-days follow-up, significant differences were found in median IPSS score (6 [IQR 3–11] versus 10 [5–13], Group A vs B, respectively, p=0.02). Urinalysis parameters and rate of positive urine cultures were not significantly different.Conclusions: The present randomized trial investigated the efficacy of Mictalase® in control of irritative symptoms and prevention of lower urinary tract infections in patients undergoing ThuLEP. IPSS improvement 30-days postoperation was more pronounced in patients who received Mictalase®. Lower rate of positive urine culture favored Mictalase® group 15-days postoperatively. The clinical trial has been registered on on November 23rd, 2021 – Registration number NCT05130918.

Petr Kaňovský ◽  
Florian Heinen ◽  
A. Sebastian Schroeder ◽  
Henry G. Chambers ◽  
Edward Dabrowski ◽  

PURPOSE: The open-label phase 3 ‘Treatment with IncobotulinumtoxinA in Movement Open-Label’ (TIMO) study investigated longer-term safety and efficacy of incobotulinumtoxin A in children/adolescents with cerebral palsy (CP). METHODS: Patients on standard treatment, with unilateral or bilateral lower limb (LL) or combined upper limb (UL)/LL spasticity received four incobotulinumtoxinA injection cycles (16 or 20 Units/kg bodyweight total [maximum 400 or 500 Units] per cycle depending on ambulatory status/clinical pattern treated), each followed by 12–16 weeks’ observation. Treatment for pes equinus was mandatory; flexed knee or adducted thigh were options for unilateral treatment and/or ULs for unilateral/bilateral treatment. The primary endpoint was safety; changes in Ashworth Scale and Gross Motor Function Measure-66 scores, and Global Impression of Change Scale scores at week 4 of each injection cycle were also evaluated. RESULTS: IncobotulinumtoxinA (≤500 Units for ≤98 weeks) was safe, well-tolerated, and effective across all endpoints for multipattern treatment of LL and combined LL/UL spasticity in ambulant/nonambulant children/adolescents with CP. Treatment effects increased with each injection cycle. No new/unexpected safety concerns were identified. CONCLUSION: IncobotulinumtoxinA showed a good safety and tolerability profile, with efficacy over multiple clinical presentations. As an adjunct treatment, it offers an effective, individualized treatment option for pediatric CP-related spasticity.

Sherif M. Badawy ◽  
Antonis Kattamis ◽  
Hatoon Ezzat ◽  
Benoît Deschamps ◽  
Eric Sicard ◽  

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