Narcolepsy
Conditions
Keywords
Narcolepsy, Cataplexy
Brief summary
This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.
Detailed description
This trial will be conducted as a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.
Interventions
Xyrem (sodium oxybate) oral solution
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial * Signed and dated an informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Experiences | continuous | Number of Subjects with treatment-emergent adverse events. |
| Vital Signs | At 1 year | Average Respiratory Rate at 1 year. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xyrem (Sodium Oxybate) | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Planned Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Xyrem (Sodium Oxybate) |
|---|---|
| Age Continuous | 47.6 years STANDARD_DEVIATION 15.37 |
| Gender Female | 41 participants |
| Gender Male | 17 participants |
| Region of Enrollment Canada | 59 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 54 / 58 |
| serious Total, serious adverse events | 11 / 58 |
Outcome results
Primary
Adverse Experiences
Number of Subjects with treatment-emergent adverse events.
Time frame: continuous
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xyrem (Sodium Oxybate) | Adverse Experiences | 54 participants |
Primary
Vital Signs
Average Respiratory Rate at 1 year.
Time frame: At 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xyrem (Sodium Oxybate) | Vital Signs | 14.0 Breaths per minute | Standard Deviation 2.4 |