Experience in Neurology
| Indication | Phase | Sample Size | Study Design/Services |
|---|---|---|---|
| Acute Pain | 3 | 1000 | Open-label, multiple-dose, multiple-day, single arm study |
| Acute Pain | 3 | 250 | Multi-center, randomized, double-blind, three-arm, active-and placebo-controlled study |
| Acute Pain | 2 | 350 | Seven treatment arm, randomized, double-blind, single-dose, and placebo- and comparator controlled, parallel-group study |
| Acute Pain | NDA | 2500 | Provided remedial services for an NDA including statistical analysis plans for ISS and ISE, preparation of numerous ad hoc analyses and validation of analyses performed by other entities |
| Acute Pain | 3 | 300 | Randomized, double-blind, active- and placebo-controlled study |
| Acute Pain | 3 | 250 | Randomized, multi-center, double-blind, placebo-controlled study |
| Dementia | 4 | 700 | Open-label extension study |
| Healthy Subjects (Acute Pain) | 1 | 15 | Open-label, single-dose study |
| Healthy Subjects (Acute Pain) | 1 | 70 | Single-center,
randomized, positive and placebo controlled, four–way, four
period, crossover study |
| Healthy Subjects (Parkinson's Disease) | 1 | 15 | Open-label, single-dose, four-period study with a randomized two-way crossover during periods 2 and 3 |
| Multiple Sclerosis | 4 | Provided study design, protocol development, and statistical analysis for several studies; completed numerous post-hoc exploratory statistical analyses for publication purposes on data from several clinical trials conducted for the marketing application | |
| Multiple Sclerosis | 3b | 100 | Randomized, multi-center, two arm, open label study followed by a safety extension/ Provided statistical consulting services including review and editing of a SAP; Prepared several presentations and lecture material describing in detail results for varied audiences including company upper management and key opinion leaders; completed a 135-slide deck depicting analyses and outcomes for multiple presentations |
| Multiple Sclerosis | 3b | 250 | Multi-center, randomized, two-arm study |
| Multiple Sclerosis | 3 | 200 | Open-label extension study |
| Multiple Sclerosis | 3 | 200 | Double-blind, placebo-controlled, parallel group study |
| Multiple Sclerosis | 3 | 200 | Multi-center, open-label extension study |
| Multiple Sclerosis | 3 | 300 | Double-blind, placebo-controlled, parallel group study |
| Multiple Sclerosis | 3 | 300 | Open-label extension study |
| Restless Legs Syndrome | 4 | 400 | Randomized, double-blind, placebo- and active-controlled study |
| Tourette's Syndrome | 2/3 | 60 | 3 studies: a phase 2, double-blind proof of concept study, a phase 2, open-label extension study and a phase 3, double-blind, proof of efficacy study |