Relypsa also completed a 104-patient multicenter, randomized, double-blind, placebo-controlled Phase IIb study, PEARL-HF, which showed that patiromer reduced the incidence of hyperkalemia in patients with heart failure, compared with placebo

The randomized, double-blind, placebo-controlled 11-week trial is expected to enroll about 180 treatment-seeking cocaine-dependent subjects at approximately 12 U.S

Marketing authorization application (MAA) filings for both vintafolide and etarfolatide have been accepted for review by the European Medicines Agency (EMA), and they are are currently being evaluated in a Phase III randomized, double-blind trial for platinum-resistant ovarian cancer (PROCEED trial) and a Phase IIb trial in patients with non-small-cell lung cancer (NSCLC

The randomized, double-blind studies, Echo 1 and Echo 2, will be conducted at nearly 200 sites worldwide and will enroll approximately 1,700 patients, aiming to demonstrate the efficacy and safety of repeated daily doses of elobixibat against placebo over a period of up to 26 weeks

The relationship with AstraZeneca goes all the way back to 2003. (See BioWorld Today, Dec. 19, 2003.) At last year's ASCO meeting, researchers from the Dana-Farber Cancer Institute presented the results of a double-blind randomized Phase II trial that showed selumetinib plus chemo improved the overall response rate in NSCLC and more than doubled progression-free survival compared to chemo alone as second-line treatment. (See BioWorld Today, June 5, 2012.) Wells Fargo analyst Matthew Andrews

N30 has moved its lead GSNOR inhibitor, N6022, into a multicenter, double-blind, randomized, placebo-controlled Phase Ib/IIa trial in CF, testing ascending doses in patients who have two copies of the F508del-CFTR mutation

The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson's disease patient complaining of sialorrhea

The double-blind, randomized, placebo-controlled study will enroll 21 participants with burn scars that restrict range of motion of jointed areas such as elbows, shoulders and fingers...The randomized, double-blind, placebo-controlled study (209AS208) evaluated the safety, tolerability and efficacy of arbaclofen in 150 ASD subjects, ages 5 to 21 years, with a particular focus on social function

The randomized, double-blind studies, Echo 1 and Echo 2, will be conducted at nearly 200 sites worldwide and will enroll approximately 1,700 patients, aiming to demonstrate the efficacy and safety of repeated daily doses of elobixibat against placebo over a period of up to 26 weeks

The benign side-effect profile was demonstrated in data published last month from a Phase I placebo-controlled, double-blind trial designed to specifically evaluate the anti-inflammatory properties of RPL554 in healthy subjects challenged with an inhaled irritant

The primary endpoint of the randomized, double-blind, placebo-controlled trial is the effect of repeat oral dosing of the Cav2.2 selective blocker on the pain experienced in PHN after three weeks, compared with baseline

The randomized, double-blind, parallel group trial is evaluating TC-1734 against donepezil (Aricept, Pfizer Inc.) in approximately 300 patients at sites predominantly in Eastern Europe and the U.S. The Alzheimer's Disease Assessment Scale-cognitive subscale and the Clinician Interview-Based Impression of Change Plus Caregiver Input, or CIBIC-(+), are co-primary endpoints, with the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory replacing CIBIC-(+) as a co-primary

Anterios has previously completed multicenter, double-blind, randomized, controlled, dose-escalation studies for each indication and demonstrated that ANT-1207 was well tolerated and demonstrated clinically and statistically significant efficacy vs

The primary objective of the double-blind, randomized, single ascending dose study is to evaluate the safety and tolerability of rHIgM22 in subjects with MS...The primary endpoint of the randomized, double-blind, placebo-controlled trial is the effect of repeat oral dosing of the Cav2.2 selective blocker on the pain experienced in PHN after three weeks, compared with baseline

Addex Therapeutics SA, of Geneva, reported preclinical data showing that its mGlu5 negative allosteric modulator oral small molecule, dipraglurant, dose-dependently prevented the abnormal excitatory effect observed on brain slices of transgenic primary generalized torsion dystonia 1 (DYT1) mice overexpressing the human mutant TOR1A gene by decreasing the paradoxical neuronal activity induced by the dopamine D2 receptor agonist quinpirole. DYT1 is a common and severe genetic form of dystonia

Ceregene Inc., of San Diego, reported top-line data from its double-blind, randomized, controlled Phase IIb study of CERE-120 (AAV-neurturin), a gene therapy designed to deliver the neurotrophic factor neurturin, for Parkinson's disease...The double-blind study enrolled 34 patients who received placebo or one of three different doses of LL-37

The 26-week, double-blind, randomized, parallel group, placebo-controlled trial will evaluate change in percent atheroma volume after 26 weeks of treatment, with safety and tolerability as secondary endpoints, as well as changes in ApoA-I, HDL-, HDL-subclasses and non-HDL lipid parameters...The company expects to report top-line results of the multicenter, randomized, double-blind, placebo-controlled, parallel group trial by year-end

MRI assessments were performed as a quantifiable and objective measure of SMF volume and thickness in the multicenter, randomized, double-blind, placebo-controlled Phase IIb study (ATX-101-09-15), which also demonstrated positive results based on validated clinician- and patient-reported outcome measures

double-blind treatment period 3/28/13 Lightlake Therapeutics Inc. (London) Intranasal naloxone Opioid antagonist nasal spray Binge eating Phase II data showed a statistically significant 75.2% reduction in binge eating 3/28/13 Navidea Biopharma-ceuticals Inc. (Dublin, Ohio) NAV4694 Fluorine-18-labeled radiopharmaceutical Mild cognitive impairment Started enrolling patients in its Phase IIb trial 3/28/13 DIABETES Biodel Inc. (Danbury, Conn.) BIOD-123 Ultra-rapid-acting prandial insulin candidate