The 350-patient study will assess the dose-response of the drug at four dose levels compared to placebo after 24 weeks, using the change in glycosylated hemoglobin as the primary endpoint...The primary endpoint of the trial is safety and tolerability of intravenous PRTX-100 over five weeks and secondary objectives include effects of the drug on measures of disease activity, immunogenicity, pharmacokinetic parameters and various safety and efficacy parameters

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data demonstrating that the first of two pivotal Phase III studies testing its sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint, which evaluated pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery

UCB SA, of Brussels, Belgium, reported results from a Phase III study showing that lacosamide monotherapy met the primary endpoint, with a significantly lower exit rate in adults with partial-onset seizures with or without secondary generalization compared with historical controls

The study met its primary endpoint, and showed a statistically significant decrease in the amount of virus in nasal secretions (viral shedding) over the seven-day study period

The primary endpoint of the study is progression-free survival, and results are expected in early 2014...The primary endpoint of the trial is progression-free survival, while secondary endpoints include response rate, overall survival and RAR beta expression, a potential biomarker for responders

The primary endpoint is objective response to the combination treatment compared to the chemotherapy alone, with overall survival as the main secondary endpoint

The primary endpoint is improvement in visual acuity (VA), defined by responder status, compared to placebo...A total of 1,000 patients will be enrolled, and the primary endpoint of both studies is the relative improvement in lung function through 24 weeks vs

The study will follow patients for 42 days, with a primary endpoint of pain with walking...The primary endpoint is the average improvement in psoriasis area and severity index from baseline at week 16

The randomized, double-blind, parallel-group, multicenter, comparative, flexible-dose study met its primary endpoint, demonstrating that a comparable proportion of patients on Lyrica achieved at least a 50 percent reduction in the 28-day seizure rate during the maintenance phase relative to levetiracetam

Up to 74 patients will be involved, and the primary endpoint is median time of progression-free survival...The study is being conducted in two parts – a single-arm study expected to enroll 240 patients, with a primary endpoint of change in serum potassium from baseline to week four, and a withdrawal phase for subjects who responded to treatment in the first part of the trial – and is being conducted under a special protocol assessment with the FDA

The 12-month trial will measure improvement in visual function as the primary endpoint, with secondary outcome measurements assessing neurologic and neuromuscular function, glutathione biomarkers, quality of life and safety...The primary endpoint is mean change in visual acuity from baseline to week 52 as measured by the Early Treatment Diabetic Retinopathy Study eye chart

Initial top-line Stage 1 results previously reported in December 2012 for the primary endpoint in Stage 1 did not meet statistical significance...The pre-specified primary and secondary analyses of the primary endpoint numerically favored migalastat HCl over placebo

Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75

The prospective, open-label study is designed to determine the safety and tolerability of hESC-derived RPE cells following subretinal transplantation into patients with myopia at 12 months, the study's primary endpoint

Primary endpoints will estimate the maximum tolerated dose and safety, while secondary endpoints include pharmacokinetics, progression-free survival and overall survival

The open-label, single-arm study will enroll about 37 patients after failure of second-line therapy, with a primary endpoint of overall response rate and secondary endpoints including progression-free survival, overall survival, median duration of response and safety

In IMPRESS I and IMPRESS II, both Xiaflex co-primary endpoints met statistical significance at 52 weeks compared to placebo, and Xiaflex was generally well tolerated...Gilead Sciences Inc., of Foster City, Calif., said top-line results showed that two Phase III trials, one testing a 12-week course of once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and the other testing the drug in combination with ribavirin and pegylated interferon (NEUTRINO), in treatment-naïve patients

The randomized, double-blind, placebo-controlled trial will enroll about 300 previously treated patients with MET-high inoperable HCC to receive tivantinib or placebo, with a primary endpoint of overall survival and a secondary endpoint of progression-free survival. (See BioWorld Today, Oct. 3, 2012, and Jan. 13, 2013...The study will compare CRXL101 to topotecan as second-line therapy, with co-primary endpoints of progression-free survival (PFS) and three-month PFS rate

The primary endpoint will be the combination endpoint of recurrent symptomatic AF and all-cause mortality over 24 weeks post-electrical cardioversion for persistent AF...Safety and effectiveness will be assessed at multiple time points, with the primary endpoints defined as three months