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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00803023 | Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia | PHASE3 | COMPLETED | 129 | — | — | Mar 1, 2010 | - | Aug 19, 2011 | 32 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sodium Oxybate Oral Solution (4.5 grams) |
| 2 | EXPERIMENTAL | Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams) |
| 3 | EXPERIMENTAL | Sodium Oxybate Oral Solution (6 grams) |
| 4 | EXPERIMENTAL | Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams) |
| Name | Type | Description |
|---|---|---|
| Sodium Oxybate | DRUG | 4.5 grams per night taken in two equally divided doses |
| Sodium Oxybate & 6 Tablets | DRUG | 4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night |
| Sodium Oxybate & 8 Tablets | DRUG | 6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night |
| Sodium Oxybate Oral Solution (6 grams) | DRUG | 6 grams per night taken in two equally divided doses |
Inclusion Criteria: * Subject is able to understand the written informed consent * Subject is 18 years of age or older. * Subject meets the ACR criteria for fibromyalgia * Subject is willing to discontinue prohibited by the protocol * Subject agrees to use only non-sedating over-the-counter (OTC)me...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 1 | PHASE3 | AXS-14 |
| Grace Therapeutics, Inc. | GRCE | 1 | — | Undisclosed |