Randomized controlled phase II trial of glatiramer acetate in ALS.
The authors conducted a randomized controlled trial to test the safety and immunology of glatiramer acetate in ALS. Twenty treated patients were randomly assigned to daily or biweekly injections. Ten control patients were selected from another trial and followed up concurrently. Injection reactions were the only common adverse event (p = 0.01). Treated patients showed enhanced lymphocyte proliferation (p = 0.02). The safety profile and immune effects support conducting larger trials of dose selection and efficacy.
Gordon
P H
PH
Department of Neurology, Columbia University, NY, USA. phg8@columbia.edu
Doorish
C
C
Montes
J
J
Mosley
R L
RL
Mosely
R L
RL
Diamond
B
B
Macarthur
R B
RB
Weimer
L H
LH
Kaufmann
P
P
Hays
A P
AP
Rowland
L P
LP
Gendelman
H E
HE
Przedborski
S
S
Mitsumoto
H
H
D004334:Drug Administration Schedule; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use* / Q000633:toxicity; D007267:Injections / Q000009:adverse effects; D008213:Lymphocyte Activation; D016472:Motor Neuron Disease / Q000188:drug therapy* / Q000276:immunology; D010455:Peptides / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D013601:T-Lymphocytes / Q000276:immunology
D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate