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| Design | Patients included, MS type | Dosage and duration | Primary and secondary outcomes | Results | Evidence |
|
Hoffmann et al., 2003 [37] | Open-label, prospective, uncontrolled, unblinded, short follow up | 36 (SP, PP) | TCA 40 mg/6 times within 3 weeks; follow up with 40 mg every 6–12 weeks; 13.1 ± 6.22, 3–23 (mean ± SD., range) months | EDSS WD | initial phase: EDSS (initial 5.6 ± 0.93 (mean ± S.D.); end: 4.9 ± 1.0; ). WD: (initial: 294 ± 314 m; end: 604 ± 540 m; ) follow up: EDSS and WD remained stable | IV |
|
Hellwig et al., 2004 [38] | Open-label, prospective, uncontrolled, unblinded, short follow up | 161 (RR, SP, PP) | TCA 40 mg/6 times within 3 weeks | EDSS WD SSEP | EDSS: (initial: 6.44 ± 1.06; end: 5.47 ± 1.24): WD: (initial 158.03 ± 501.20, end: 439.38 ± 895.24). SSEP latencies: reduced for all variables () | IV |
|
Hoffmann et al., 2006 [39] | Open-label, prospective, uncontrolled, unblinded, short follow up | 27 (SP, PP) | TCA 40 mg/6 times within 3 weeks | EDSS WD WT 25-f-test CSF changes | EDSS: (initial: 5.4 ± 1.3; end: 4.9 ± 1.1; ). WD and WT increased: , 25 f-test increased: CSF changes n.s. | IV |
|
Hellwig et al., 2006 [40] | open-label over a 52-week long interval, prospective, randomized, unblinded | TCA: 34 (SP, PP) MIX: 30 (SP, PP) | TCA: 40 mg every 6–12 weeks, 52 weeks MIX: initial dose: 12 mg/m2 2nd dose: 8–10 mg/m2 6 weeks later/then quarterly: 52 weeks | EDSS WD | TCA: EDSS decreased () WD: increased () MIX: EDSS, WD n.s. | III |
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