A phase II study of i.v. methylprednisolone in secondary-progressive multiple sclerosis.
OBJECTIVE
To compare the tolerability and efficacy of two doses of i.v. methylprednisolone in patients with secondary-progressive MS.


METHODS
I.v. methylprednisolone administered in high or low dose every other month for up to 2 years to 108 patients with secondary-progressive MS.


RESULTS
No significant difference in efficacy with the primary outcome, a comparison of the proportions of patients in each treatment group who experienced sustained progression of disability. A relative treatment effect was detected with the high-dose regimen as measured by the preplanned secondary analysis, a comparison of time to onset of sustained progression of disability. Drug-related adverse events were observed more frequently in high-dose recipients but serious drug-related adverse events were uncommon, and cessation of study drug was only required in one patient.


CONCLUSIONS
The results of the secondary analysis of this study suggest that a phase III trial of corticosteroids for secondary-progressive MS is warranted.
UCSF/Mt. Zion Multiple Sclerosis Center, San Francisco, CA 94115, USA.
D E
DE
Goodkin
R P
RP
Kinkel
B
B
Weinstock-Guttman
S
S
VanderBrug-Medendorp
M
M
Secic
D
D
Gogol
J E
JE
Perryman
M M
MM
Uccelli
L
L
Neilley
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis; D017211:Treatment Failure
D000893:Anti-Inflammatory Agents; D008775:Methylprednisolone