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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jazz Pharmaceuticals
• Treatments: Pharmaceutical Solutions; Sodium Oxybate

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.