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
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Sodium Oxybate; Sodium Oxybate & 6 Tablets; Sodium Oxybate & 8 Tablets; Sodium Oxybate Oral Solution (6 grams)
Intervention description: 4.5 grams per night taken in two equally divided doses; 4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night; 6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night; 6 grams per night taken in two equally divided doses
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        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.