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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Sodium Oxybate
* Drug: Sodium Oxybate & 6 Tablets
* Drug: Sodium Oxybate & 8 Tablets
* Drug: Sodium Oxybate Oral Solution (6 grams)


Participation Criteria
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Eligibility Criteria
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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)medication Subject is willing to abstain from the ingestion of alcohol for the duration of the trial. Exclusion Criteria: Subject has protocol prohibited medical & psychiatric conditions that would exclude subject Subject has a current or past history of a substance use disorder including alcohol abuse Subject has a clinically significant history of seizure disorder either past or present Female subject who is pregnant, nursing or lactating. Subject is diagnosed with sleep apnea Subject is unable to discontinue protocol prohibited medications Subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications. Subject has taken any investigational drug within 5 half-lives of the investigational drug prior to signing the informed consent form. Subject has an allergic reaction to GHB or sodium oxybate or any of its constituents (e.g. malic acid). Subject is on a sodium-restricted diet. Subject has abnormal liver function test or other abnormal lab values Subject has an occupation that requires variable shift work or routine night shifts or cannot routinely spend at least 6 hours per night in bed. Subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms. Subject has been randomized into a previous Xyrem (sodium oxybate) clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sodium Oxybate Oral Solution (4.5 grams) | Drug: Sodium Oxybate<br>* 4.5 grams per night taken in two equally divided doses<br>|
| Experimental: 2<br>Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams) | Drug: Sodium Oxybate & 6 Tablets<br>* 4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night<br>|
| Experimental: 3<br>Sodium Oxybate Oral Solution (6 grams) | Drug: Sodium Oxybate Oral Solution (6 grams)<br>* 6 grams per night taken in two equally divided doses<br>|
| Experimental: 4<br>Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams) | Drug: Sodium Oxybate & 8 Tablets<br>* 6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability Assessed by Adverse Events |  | 4 weeks |