Clinical Trial Resource Center

Clinical Trial Resource Center

Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of April 20, 2015

Alkermes released positive results from a phase II study of ALKS 3831 for schizophrenia. The six-month, randomized, multicenter, dose-ranging study consisted of two three-month stages. The initial three-month stage was a double-blind, active-controlled study. A total of 309 patients were randomized in the study, and the 300 patients who had at least one post baseline Positive and Negative Syndrome Scale (PANSS) assessment were included in the full study population. In the study, following a one-week oral leadin of olanzapine, patients were randomly assigned to treatment with olanzapine or one of three different doses of ALKS 3831 (olanzapine + 5mg, 10mg or 20mg samidorphan). For patients who received ALKS 3831 throughout the entire six-month treatment period, efficacy, as evaluated by the reduction from baseline in PANSS total scores, was equivalent to olanzapine during the initial three-month stage and this efficacy was maintained throughout the second threemonth stage (change in PANSS total score from week 12 to week 24 was -1.7 points, 95% confidence interval (CI): (-2.7, -0.7)). The beneficial effect on weight gain observed during the initial three months also was maintained during the second three-month stage. Mean percent change in body weight, from week 12 to week 24, was 0.5%, 95% CI: (-0.2%, 1.2%), indicating a consistent and durable blockade of olanzapine-induced weight gain. Alkermes plans to meet with the FDA for an end-of-phase II meeting and advance ALKS 3831 into a pivotal development program in 2015

Kala Pharmaceuticals reported results of a phase III study of KPI-121 for the treatment of inflammation and pain in patients who had undergone cataract surgery. The multicenter, randomized, double-masked, vehicle-controlled, parallel-group trial in 380 patients was designed to evaluate two dosing regimens of KPI-121 ophthalmic suspension v. vehicle. Patients were randomized to receive either 0.25% KPI-121 four times daily, 1% KPI-121 two times daily or their corresponding vehicles administered for two weeks. At day eight, statistically significant differences favoring KPI-121 were achieved for the primary endpoint of complete resolution of inflammation with both 1% KPI-121 dosed twice a day (p=0.0024) and 0.25% KPI-121 dosed four times a day (p<0.0001). Complete resolution of ocular pain by day eight (also a primary endpoint) was achieved for 1% KPI-121 dosed twice a day (p=0.0019) and 0.25% KPI-121 dosed four times a day (p=0.0003). KPI-121 achieved all primary efficacy endpoints and was generally well-tolerated, with no significant treatment-related safety findings observed during the course of the trial.

Ocular Therapeutix issued results from the second of two phase III trials of OTX-DP (Sustained Release Dexamethasone, 0.4mg), for the treatment of ocular inflammation and pain following cataract surgery. The randomized, parallel-arm, double-masked, vehicle-controlled trials were completed with a total of 487 patients (247 patients in the first phase III trial and 240 patients in the second phase III trial) undergoing unilateral clear corneal cataract surgery. Patients were randomized 2:1 to receive either OTX-DP or a placebo vehicle control punctum plug without active drug. 77.5% of patients receiving OTX-DP reported an absence of pain in the study eye on day eight following insertion of the drug product, compared to 58.8% of those receiving placebo vehicle control punctum plug, a difference which was statistically significant (p=0.0025). 39.4% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 following drug product insertion, compared to 31.3% of those receiving placebo vehicle control punctum plug, a difference which was not statistically significant (p=0.2182). The company examined the aggregate result on a post-hoc basis of the absence and very minimal presence of inflammatory cells (defined as zero and 0.5 on a scale of zero to 4) and the difference between the treatment and placebo groups was found to be highly significant (66.3% in the treatment group and 42.5% in the placebo group, p=0.0004). There were no ocular or treatment-related serious adverse events in the OTX-DP treatment group in either trials.