Jha 2008.

Methods	Twelve week (first phase) single centre randomised placebo‐controlled cross‐over trial. Recruitment conducted from November 2002 to March 2005.
Participants	Fifty‐one males and females in the United States aged 16 to 65, at least one year post traumatic brain injury who required in‐patient rehabilitation. Experiencing fatigue or excessive daytime sleepiness, or both, which compromises optimal day time functioning.
Interventions	Treatment: Modafinil 100 mg daily for three days, then 100 mg twice daily for 11 days, followed by 200 mg twice daily for eight weeks. Followed by a four‐week washout period and then cross‐over. Dose reduction to 200 mg daily if non‐tolerance of 400 mg daily. Placebo: Placebo tablets with the same timings as for the treatment arm.
Outcomes	Medical Outcome Study 12‐Item Short Form Survey (SF‐12). Immediate Post Concussion Assessment Cognitive Testing (ImPACT): Computerised cognitive test battery assessing verbal memory, visual memory, visual motor speed and reaction time. Conners' Continuous Performance Test II (CPT‐II): Computerised test of vigilance developed for individuals with attention deficit hyperactivity disorder. Measures were administered at baseline, week four and week ten of treatment, repeated at week four and week ten following cross‐over. Attrition rates for each arm were reported. Number and type of adverse events for each arm were reported.
Funding	The study was supported by the US Department of Education, Office of Special Education and Rehabilitation Services, National Institute on Disability and Rehabilitation Research and Cephalon Inc.
Declarations of interest	None reported.
Notes	Adverse event data for phase 1 were provided by the study author.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated randomisation sequence.
Allocation concealment (selection bias)	Low risk	Pharmacy department responsible for maintaining study blinding, who administered modafinil or placebo according to the randomisation sequence.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and personnel blinded to allocation.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Investigators, study coordinator, data collectors, analysts blinded to allocation.
Incomplete outcome data (attrition bias) All outcomes	High risk	Fifty‐one participants randomised, with only 49 included in the analysis. No reference to intention‐to‐treat analysis.
Selective reporting (reporting bias)	Low risk	Outcomes were reported as planned in the study protocol.
Other bias	Unclear risk	The primary outcome of the study investigated treatment of fatigue and not cognitive functioning.