Fibromyalgia
Conditions
Keywords
FMS, Fibro, Pain, Body Pain, Tenderness, Joint pain, Stiffness, Muscular Pain
Brief summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Detailed description
The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.
Interventions
DRUGXyrem®
flexible dosing
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137). * Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.
Exclusion criteria
* Subject terminated early from either study 06-009 or 06-008. * Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008. * Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Adverse Events | Treatment Period (38 weeks) | Number of subjects reporting adverse events. |
Countries
France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xyrem 4.5 g to 9.0 g Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses | 560 |
| Total | 560 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 129 |
| Overall Study | Lack of Efficacy | 38 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Not one of the pre-specified options | 5 |
| Overall Study | Physician Decision | 8 |
| Overall Study | Protocol Violation | 7 |
| Overall Study | Sponsor Decision | 3 |
| Overall Study | Withdrawal by Subject | 36 |
Baseline characteristics
| Characteristic | Xyrem 4.5 g to 9.0 g |
|---|---|
| Age Continuous | 46.9 years STANDARD_DEVIATION 10.84 |
| Age, Customized 18 - 39 years | 144 participants |
| Age, Customized 40 - 49 years | 181 participants |
| Age, Customized 50 - 64 years | 212 participants |
| Age, Customized >=65 years | 23 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 512 Participants |
| Region of Enrollment France | 13 participants |
| Region of Enrollment Germany | 34 participants |
| Region of Enrollment Italy | 3 participants |
| Region of Enrollment Netherlands | 2 participants |
| Region of Enrollment Spain | 35 participants |
| Region of Enrollment United Kingdom | 8 participants |
| Region of Enrollment United States | 465 participants |
| Sex: Female, Male Female | 510 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 498 / 560 |
| serious Total, serious adverse events | 19 / 560 |
Outcome results
Primary
Number of Subjects Reporting Adverse Events
Number of subjects reporting adverse events.
Time frame: Treatment Period (38 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xyrem 4.5 g to 9.0 g | Number of Subjects Reporting Adverse Events | 498 Participants |