Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00752505 | A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia. | PHASE2 | COMPLETED | 89 | — | — | Aug 1, 2008 | Jun 1, 2009 | Dec 4, 2018 | 7 | United States |
| NCT00809289 | Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers | PHASE1 | COMPLETED | 40 | — | — | Dec 1, 2008 | Jul 1, 2009 | Apr 7, 2011 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| One | EXPERIMENTAL | - |
| Two | PLACEBO_COMPARATOR | - |
| Three | ACTIVE_COMPARATOR | Administration of a single oral dse of 400mg moxifloxacin |
| Name | Type | Description |
|---|---|---|
| Esreboxetine | DRUG | Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing |
| placebo | DRUG | Once daily administration of placebo for 9 days. Placebo will be administered double blind |
| moxifloxacin | DRUG | Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9 |
Inclusion Criteria: * Subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. Control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender Exclusion Criteria: * Other confound...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 1 | PHASE3 | AXS-14 |
| Grace Therapeutics, Inc. | GRCE | 1 | — | Undisclosed |