scholarly journals A pilot, open-label study of the effectiveness and tolerability of low-dose ZX008 (fenfluramine HCl) in Lennox-Gastaut syndrome

Epilepsia ◽  
2018 ◽  
Vol 59 (10) ◽  
pp. 1881-1888 ◽  
Author(s):  
Lieven Lagae ◽  
An-Sofie Schoonjans ◽  
Arnold R. Gammaitoni ◽  
Bradley S. Galer ◽  
Berten Ceulemans
Keyword(s):  
Low Dose ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals P129: A phase IV real world study on the use of low dose methoxyflurane (PENTHROX™) for the treatment of moderate to severe trauma pain in the Canadian emergency department (ADVANCE-ED): an interim report on secondary outcomes

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S111-S111
Author(s):  
S. Campbell ◽  
E. Simard ◽  
A. Arcand ◽  
L. Blagrove ◽  
P. Piraino ◽  
...  
Keyword(s):  
Pain Relief ◽  
Adverse Events ◽  
Acute Pain ◽  
Real World ◽  
Rescue Medication ◽  
Low Dose ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Phase Iv

Introduction: Inhaled low dose methoxyflurane (MEOF) was recently approved in Canada for the short-term relief of moderate to severe acute pain associated with trauma or interventional medical procedures in conscious adult patients. ADVANCE-ED is an ongoing phase IV, prospective open label study undertaken to generate real-world evidence to complement the global clinical development program through evaluation of the effectiveness of low dose MEOF in Canadian emergency departments (EDs). Methods: This multi-centre study is enrolling adult (≥18 yrs) patients with moderate to severe acute pain (NRS0-10 ≥ 4) associated with minor trauma. To address limitations from the pivotal study, this study allows patients who were excluded in the pivotal trials: namely, those with severe (≥7) pain, and those using OTC or stably dosed analgesics for other conditions, including chronic pain. Eligible patients receive a single treatment of up to 2 x 3 mL MEOF (2nd 3 mL to be provided only upon request), self-administered by the patient under medical supervision. Rescue medication is permitted at any time, if required. Results: Here we describe the patient demographics and treatment satisfaction (Global Medication Performance, GMP) at 50% enrolment (n = 49). Mean (SD) patient age is 48.0 (17.1) yrs and 55.1% are female. Mean pain (SD) reported at enrolment is 8.3 (1.5), with 73.4% of patients with NRS0-10 ≥ 8. Injuries are overwhelmingly limb trauma (87.8%). The most common type is sprain/strain (40.8%), followed by fracture (32.7%). At 5 minutes post-start of administration (STA) of MEOF, 80.4% of patients reported pain relief; this increased to 91.3% at 15 minutes, and 100% of patients reported pain relief by 30 minutes post-STA. GMP was assessed as “good”, “very good” or “excellent” by ≥80% of patients both 20 minutes post-start of administration (STA) of MEOF (83.3%) and at discharge (85.8%). When asked to what extent their expectation of pain relief had been met, 32.7% responded good, 26.5% responded “very good” and 22.4% responded “excellent”. Three quarters of enrolled patients (75.5%) did not require rescue medication. The most common (≥5%) treatment-related adverse events were dizziness (n = 14, 28.6%) and euphoric mood (n = 4, 8.2%). No serious adverse events have been reported. Conclusion: Based on 50% of the patients enrolled in this prospective, open label study, responses to inhaled low-dose MEOF are within expectation for both effectiveness and tolerability.

scholarly journals RBTT-01. RANDOMIZED PHASE 2 OPEN LABEL STUDY OF NIVOLUMAB PLUS STANDARD DOSE BEVACIZUMAB VERSUS NIVOLUMAB PLUS LOW DOSE BEVACIZUMAB IN RECURRENT GLIOBLASTOMA

2018 ◽  
Vol 20 (suppl_6) ◽  
pp. vi234-vi234 ◽  
Author(s):  
Manmeet Ahluwalia ◽  
David Peereboom ◽  
Cathy Schilero ◽  
Deborah Forst ◽  
Eric Wong ◽  
...  
Keyword(s):  
Low Dose ◽  
Standard Dose ◽  
Recurrent Glioblastoma ◽  
Phase 2 ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Randomized Phase 2

Low-dose levomepromazine in refractory emesis in advanced cancer patients: an open-label study

2005 ◽  
Vol 19 (1) ◽  
pp. 71-75 ◽  
Author(s):  
Jorge H Eisenchlas ◽  
Nicolás Garrigue ◽  
Marta Junin ◽  
Gustavo G De Simone
Keyword(s):  
Cancer Patients ◽  
Advanced Cancer ◽  
Low Dose ◽  
Advanced Cancer Patients ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Refractory Emesis

scholarly journals Phase Ib/II randomized, open-label study of doxorubicin and cyclophosphamide with or without low-dose, short-course sunitinib in the pre-operative treatment of breast cancer

Oncotarget ◽  
2016 ◽  
Vol 7 (39) ◽  
pp. 64089-64099 ◽  
Author(s):  
Andrea L.A. Wong ◽  
Raghav Sundar ◽  
Ting-Ting Wang ◽  
Thian-C Ng ◽  
Bo Zhang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Operative Treatment ◽  
Low Dose ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Phase Ib ◽  
Short Course

scholarly journals Inhaled Low-Dose Iloprost for Pulmonary Hypertension: A Prospective, Multicenter, Open-Label Study

2012 ◽  
Vol 35 (6) ◽  
pp. 365-370 ◽  
Author(s):  
Yun-Juan Sun ◽  
Chang-Ming Xiong ◽  
Guang-Liang Shan ◽  
Qing Gu ◽  
Wei-Jie Zeng ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Low Dose ◽  
Open Label ◽  
Open Label Study ◽  
Label Study
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