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

Phase 3

Completed

Interventions: Drug: Sodium Oxybate
Drug: Sodium Oxybate & 6 Tablets
Drug: Sodium Oxybate Oral Solution (6 grams)
Drug: Sodium Oxybate & 8 Tablets

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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
1	Sodium Oxybate	Sodium Oxybate Oral Solution (4.5 grams)
2	Sodium Oxybate & 6 Tablets	Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams)
3	Sodium Oxybate Oral Solution (6 grams)	Sodium Oxybate Oral Solution (6 grams)
4	Sodium Oxybate & 8 Tablets	Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)

Primary Outcome Measures

Name	Time	Method
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects	4 weeks

Secondary Outcome Measures

Name	Time	Method
Tolerability Assessed by Adverse Events	4 weeks

Locations (32): Dba 21st Century Neurology
🇺🇸
Phoenix, Arizona, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Advanced Clinical Research Institute
🇺🇸
Anaheim, California, United States
Orange County Clinical Trials
🇺🇸
Anaheim, California, United States
Med Investigations, Inc.
🇺🇸
Fair Oaks, California, United States
Northridge Neurological Center
🇺🇸
Northridge, California, United States
Arroyo Medical Group, Inc.
🇺🇸
Pismo Beach, California, United States
Northern California Research
🇺🇸
Sacramento, California, United States
Superior Research, LLC
🇺🇸
Sacramento, California, United States
Apex Research Institute
🇺🇸
Santa Ana, California, United States
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Dba 21st Century Neurology
🇺🇸Phoenix, Arizona, United States