| Methods |
Single‐blind cross‐over versus placebo: run‐in period of 15 days; each treatment period of 6 weeks; not known if a wash‐out period was performed. |
| Participants |
56 participants with narcolepsy.
Mean and range of age not known.
Place of the study: Canada and US (not specified ethnic composition of participants).
Inclusion criteria: history of EDS, presence of at least one of the REM sleep‐related symptoms (cataplexy, sleep paralysis, hypnagogic hallucinations), and two or more sleep‐onset REM periods at MSLT.
Exclusion criteria: not reported.
Recruitment procedures: not reported.
Mean duration of the disorder: not reported.
Pre‐trial treatment: not reported. |
| Interventions |
Viloxazine: other antidepressants class (N06AX09); dosage 100 mg per day.
Placebo. |
| Outcomes |
Considered in the review and present in the study:
(1) Reduction of EDS according to objective laboratory test (MSLT and MWT) at the long‐term follow‐up.
(2) Reduction of cataplexy measured with the comparison of mean values of a subjective ordinal scale between treatment groups at the long‐term follow up. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Unclear |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
High risk |
Procedures of generation and concealment sequences: unclear.
Procedures to make recipients unaware of the assigned therapy: unclear.
Procedures to make those providing care unaware of the assigned therapy: unblinding.
Procedures of blinding (unawareness of the assigned therapy in the group of those measuring outcomes): undeclared. |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Possible attrition bias: 20 participants lost to follow up. |
| Free of other bias? |
Unclear risk |
It is not known if a washout period was applied. |
