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Also known as Sodium Oxybate
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...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 2 | PHASE3 | AXS-14 |
Sodium oxybate is a small molecule drug that Jazz Pharmaceuticals plc develops under the ticker JAZZ. It is being studied across several conditions, including alternating hemiplegia of childhood, binge eating disorder, essential tremor, fibromyalgia, and schizophrenia. The program is at Phase 1 development overall.
Sodium oxybate targets GABBR1 and GABBR2, the two subunits of the GABA-B receptor. It acts as an agonist at these receptors, meaning it activates GABA-B receptor signaling. This receptor activity is the basis for its study across neurological and psychiatric conditions.
Sodium oxybate is developed by Jazz Pharmaceuticals plc, which trades under the ticker JAZZ. Jazz Pharmaceuticals is the sponsor behind the clinical program evaluating the drug in alternating hemiplegia of childhood, fibromyalgia, essential tremor, and schizophrenia with insomnia.
Sodium oxybate is in Phase 1 development overall and is investigational. Its clinical program includes completed studies at Phase 1, Phase 2, and Phase 3, but the drug has not been established as approved for the conditions under study. No trials are currently active.
Sodium oxybate has been studied in completed trials including NCT00931164 in alternating hemiplegia of childhood, NCT00803023 in fibromyalgia, NCT00598078 in essential tremor, and NCT00594256 in schizophrenia with insomnia. All four trials are completed, and none are currently active.