Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oxybate · 5 trials · 6 indications
This rating scale generates a global sleep-quality score, as well as scores on 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 19 items are combined to form seven "component" scores, each of which has a range of O-3 points. The seven component scores are then added to yield one "global" score, with a range of O-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Designed to measure daytime sleepiness. 8 items rated 0-3, with higher scores associated with a greater daytime sleepiness. overall score rated 0-24, with scores greater than 10 indicating significant daytime sleepiness.
The modified FTM sum of all essential rating tremor scales including voice tremor includes: the tremor rating taken for the left \& right hands individually at rest, with posture (arms outstretched), with action (finger to nose). It also includes an evaluation of voice with scores for AAA \& EEE sounds, an action evaluation of left \& right hands pouring, bringing liquids to mouth, drawing large \& small spirals. Scores for indiviuals items range from 0 (no tremor) to 4 (severe tremor). The sum ranges from 0 (no tremor) to 72 points (higher amplitude/more tremors).
| 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) |
| Sodium oxybate | EXPERIMENTAL | Active treatment |
| 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 |
| Placebo | OTHER | Dose 3 |
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 |
Oxybate is an investigational small molecule being studied for Binge Eating Disorder, Fibromyalgia, Alternating Hemiplegia of Childhood, Schizophrenia, and Essential Tremor. It is developed by Jazz Pharmaceuticals plc. As of the latest data, it is in Phase 1 clinical development, though some studies for other indications have reached Phase 2 or Phase 3.
Oxybate is developed by Jazz Pharmaceuticals plc, a company traded on the NASDAQ under the ticker JAZZ. The drug is an investigational small molecule being evaluated for multiple conditions, including Binge Eating Disorder and Fibromyalgia.
Oxybate is currently in Phase 1 clinical development. However, clinical trials have been conducted in various phases: a Phase 1 study for Alternating Hemiplegia of Childhood, Phase 2 studies for Binge Eating Disorder and Essential Tremor, and a Phase 3 study for Fibromyalgia. All these trials are completed.
Oxybate has been studied in several completed clinical trials. These include NCT00514995 for Binge Eating Disorder, NCT00598078 for Essential Tremor, NCT00803023 for Fibromyalgia, and NCT00931164 for Alternating Hemiplegia of Childhood. The trials were conducted in the United States with a total enrollment of 129 participants.
Oxybate is also known as sodium oxybate. Clinical trials listed under the drug name Oxybate explicitly use sodium oxybate as the intervention, such as in studies for Binge Eating Disorder, Essential Tremor, Fibromyalgia, and Alternating Hemiplegia of Childhood.