| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00423605 | Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia. | PHASE3 | COMPLETED | 560 | — | — | Dec 1, 2006 | Jan 1, 2010 | Mar 30, 2012 | 91 | United States, France +5 |
| NCT00423813 | A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia. | PHASE3 | COMPLETED | 573 | — | — | Dec 1, 2006 | Jun 1, 2009 | Jan 24, 2012 | 116 | United States, France +6 |
| NCT00371137 | A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia | PHASE3 | COMPLETED | 548 | — | — | Aug 1, 2006 | Dec 1, 2008 | Dec 29, 2011 | 70 | United States |
| NCT00087555 | Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia | PHASE2 | COMPLETED | 195 | — | — | Jul 1, 2004 | Jan 1, 2006 | Jan 24, 2012 | 20 | United States |
Number of subjects reporting adverse events.
Percentage of pain VAS responders. Subjects with a \>= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.
The percentage of participants who met all 3 of the following criteria: Reduction of \>=20% from baseline to week 8 in both PVAS \& FIQ total score and PGI-C response of "very much better" or "much better". Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from "very much worse" to "very much better"
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | Placebo (one of two doses matching active treatment by volume). |
| Name | Type | Description |
|---|---|---|
| Xyrem® | DRUG | flexible dosing |
| placebo | DRUG | Oral Solution |
| Xyrem (sodium oxybate) oral solution | DRUG | Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks. |
Inclusion Criteria: * Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137). * Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months. Exclusion Criteria: * Subject terminated early from either study 06-009 or...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 1 | PHASE3 | AXS-14 |
| Grace Therapeutics, Inc. | GRCE | 1 | — | Undisclosed |