Conditions: Fibromyalgia
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 129
Healthy volunteers: no

Brief summary:
To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).

Detailed description:

Arms:
arm 1: Sodium Oxybate Oral Solution (4.5 grams) arm 2: Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams) arm 3: Sodium Oxybate Oral Solution (6 grams) arm 4: Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)

Interventions: intervention 1: Sodium Oxybate intervention 2: Sodium Oxybate & 6 Tablets intervention 3: Sodium Oxybate & 8 Tablets intervention 4: Sodium Oxybate Oral Solution (6 grams)
Intervention descriptions: intervention 1: 4.5 grams per night taken in two equally divided doses intervention 2: 4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night intervention 3: 6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night intervention 4: 6 grams per night taken in two equally divided doses

Protocol document: