Innovations In Clinical Neuroscience

CNS Summit 2016

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 4 , N U M B E R 1 – 2 , J A N U A R Y – F E B R U A R Y 2 0 1 7 , S U P P L E M E N T ] S10 Optimizing the mobile clinical trial: data collection through a web-based platform in telemedicine protocol P resenters: Shaw M 1 , Song G 2 , Charvet L 1 , Beringer J 3 , Waibel U 3 Affiliations: 1 NYU School of Medicine, New York, New York; 2 Stony Brook Medicine, Stony Brook, New York; 3 B erisoft Corp., Redwood City, California Objective: A web-based platform was employed to administer cognitive testing and self-reported mood in a clinical trial where the intervention was administered remotely to participants at home through telerehabilitation. Design: Using a remotely supervised telemedicine protocol, our study tested the benefit of transcranial direct current stimulation (tDCS) for participants with multiple sclerosis (MS). Participants completed daily assessments along with their treatments through a study- provided laptop. To avoid paperwork and to access data in real-time, we utilized the ERTSLab online platform, administrable from any computer with an internet connection. Cognitive functioning was measured by the Attention Networks Test-Interaction (ANT-I), and self-reported mood was measured using the Positive and Negative Affect Schedule (PANAS) taken from the Cognition Library of ERTSLab. Results: For the ANT-I, excellent form reliability was found between ERTSLab and the PC-installed ePrime version. Form reliability was excellent (r=0.90). Using the ERTSLab version, in our MS sample we found significant improvement in alerting scores for the treatment (n=6) versus control (n=4) conditions (p=0.031). For the PANAS self-reported mood measure, online versus standard forms were similarly validated (r=0.90). For the study, 13 participants completed a daily PANAS assessment along with their treatment sessions, and we found a trend toward statistically significant improvement in positive (p=0.001) and negative (p=0.70) affects for those in the treatment versus control condition. Conclusion: Online platforms, such as ERTSLab ,provide a mobile platform to administer cognitive assessment and self-reported symptom inventories in study designs where participants are assessed in remote locations including the use of telerehabilitation. Disclosures/funding: None reported. INVESTIGATIVE DRUG COMPOUNDS AND THERAPIES The AtEase study: treatment of military- r elated PTSD Presenters: Peters P 1 , Gendreau R 2 , Gendreau J 1 , Sullivan G 1 , Peters A 1 , Engels J 3 , Schaberg A 4 , Jividen H 1 , Lederman S 1 Affiliations: 1 Tonix Pharmaceuticals, Inc., New York, New York; 2 Gendreau Consulting, Poway, California; 3 Engels Statistical Consulting LLC, Minneapolis, Minnesota; 4 Schaberg Consulting, Cary, North Carolina Objective: Our objective was to perform a post-hoc analysis of the safety and efficacy of TNX-102 SL 5.6mg compared to placebo in posttraumatic stress disorder (PTSD) patients, as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score. Design: 'AtEase' was a Phase 2, multicenter, 12-week, randomized, controlled trial in adults meeting a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of PTSD as assessed by CAPS- 5. Patients were randomized to TNX-102 SL 2.8mg, 5.6mg, or placebo in a 2:1:2 ratio. Eligible participants had PTSD criterion "A" qualifying trauma(s) during military service since 2001 with a baseline CAPS-5 severity score of 29 or greater. The primary efficacy endpoint was mean change from baseline (MCFB) in total CAPS-5 score at Week 12. Results: Compared to placebo (n=92), patients who received TNX-102 SL 5.6mg (n=49) experienced a substantially greater MCFB in CAPS-5 at Week 12 (p=0.053; effect size (ES)=0.36). A post-hoc analysis of the subset with a baseline CAPS-5 score of 33 or higher which was shown to be a closer estimate to prior CAPS version entry scores of 50 or higher (used in previous studies), demonstrated larger separation from placebo. Treatment differences between placebo (n=77) and TNX-102 SL 5.6mg (n=38) were significant for the primary endpoint of CAPS-5 (p=0.013; ES=0.53) as well as on multiple secondary endpoints. The most commonly reported adverse events in this subset were oral hypoaesthesia, somnolence, and dry mouth, similar to the original study population. C onclusion: TNX-102 SL 5.6mg was superior to placebo with a substantial ES when adjusting the CAPS-5 minimum entrance criteria to match previous PTSD studies. D isclosures/funding: TNX-102 SL is an investigational new drug and has not been approved for any indications. The clinical development of ITI-007 for the treatment of schizophrenia Presenters: Vanover K, Glass S, O'Gorman C, Saillar J, Weingart M, Correll C, Mates S, Davis R Affiliations: Intra-Cellular Therapies, Inc., New York, New York Objective: ITI-007, an investigational agent acting through serotonergic, dopaminergic, and glutamatergic systems, is in development for schizophrenia, bipolar depression, and agitation associated with dementia. Here we report on the schizophrenia program. Design: ITI-007-005 was a four-week Phase 2 trial, wherein 335 patients were randomized to receive orally once-daily: ITI-007 (60mg or 120mg), risperidone (positive control), or placebo. ITI-007-301 was the first of two Phase 3 trials, wherein 450 patients were randomized to receive either ITI-007 (60mg or 40mg) or placebo for four weeks. ITI-007-302 was the second Phase 3 trial, and 696 patients were randomized to receive ITI-007 (60mg or 20mg), risperidone (positive control), or placebo for six weeks. The primary efficacy endpoint is Positive and Negative Symptom Scale (PANSS) total score change from baseline versus placebo. Results: In ITI-007-005 and ITI-007- 301, ITI-007 60mg met the primary endpoint. In ITI-007-301, ITI-007 60mg, with no dose titration, showed early and sustained efficacy on both the PANSS total and Positive Symptom Subscale and met the key secondary endpoint with significant improvement on CGI-S. In ITI- 007-301, ITI-007 40mg separated significantly from placebo on the PANSS Positive Symptom subscale as well as CGI-S. Pro-social benefits were also observed. ITI-007 was safe and well- tolerated with a motor and cardio- metabolic safety profile similar to placebo.

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