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Table 7.5 Modafinil for the Management of Fatigue Post ABI

by | Dec 12, 2018

Table 7.5 Modafinil for the Management of Fatigue Post ABI

Author Year

Country

Study Design

Sample Size

 Methods Outcome

Kaiser et al. (2010)

Switzerland

RCT

PEDro=9

N=20

Population: TBI=20; Gender: Male=17, Female=3. Treatment Group (n=10): Mean Age=37yr; Mean GCS=7. Control Group (n=10): Mean Age=43yr; Mean GCS=8.

Intervention: Patients received either 100-200mg modafinil or placebo every morning for 6wk.

Outcome Measure: Excessive Daytime Sleepiness (EDS), Fatigue Severity Scale (FSS), Maintenance of Wakefulness Test (MWT).

1.        At 6 weeks, the decrease in FSS scores was greater in the modafinil group compared to the control group (-0.8± 1.0 versus 0.0± 0.6) but this was not significant (p=0.07).

2.        The modafinil group had greater decreases in EDS scores versus placebo (p<0.005).

3.        On the MWT, a significantly greater improvement was shown for the modafinil group when compared to placebo (8.4± 9.6 versus 0.4± 6.2 min, p=0.04).

4.        Of those patients with fatigue at baseline (FSS≥4), decreases in FSS scores were not greater in the treatment group.

Jha et al. (2008)

USA

RCT

PEDro=8

NInitial=51, NFinal=46

Population: TBI=51; Mean Age=38.25yr; Gender: Male=35, Female=16; Mean Time Post Injury=5.77yr.

Intervention: The treatment group (n=27) received modafinil (100 mg/d for 3d, then 200 mg/d for 11d, then a maintenance dose of 400 mg/d for 8wk). The control group (n=24) received a placebo. At the end of phase 1 (8wk) both groups crossed-over.

Outcome Measure: Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFI), Epworth Sleepiness Scale (ESS).

 1.        No significant between-group differences were found at week 4 or week 10 on the FSS (p=0.80 and p=0.61, respectively) or the MFI (p=0.67 and p=0.73, respectively). 2.        The change in ESS scores was significantly greater in the modafinil group versus placebo at 4wk (p=0.02) but not at 10wk (p=0.56). 3.        Adverse events for the treatment group included: headaches (29.5%), insomnia (19.6%), fatigue (9.8%), dizziness (7.8%), and tremors (5.9%). 4.        Adverse events for placebo: headaches (19.6%) and nasoppharyngitis (5.9%).