Introduction
Methods
Study design
Patients
MRI/MTR methods
Quality assurance
Statistical analysis
Results
Patients
Characteristic | Placebo (n = 147) | Delayed-release DMF BID (n = 152) | Delayed-release DMF TID (n = 149) |
---|---|---|---|
Mean (SD) MTR of whole brain | 37.1 (5.7) | 37.1 (6.1) | 37.3 (6.1) |
Median (min, max) MTR of whole brain | 34.5 (29, 51) | 34.0 (28, 51) | 36.4 (28, 50) |
Mean (SD) MTR of normal-appearing brain tissue | 38.1 (5.6) | 38.1 (6.0) | 38.3 (6.0) |
Median (min, max) MTR of normal-appearing brain tissue | 35.3 (29, 52) | 35.1 (29, 52) | 37.5 (28, 51) |
MTR in whole brain and NABT
Placebo (n = 135) | Delayed-release DMF BID (n = 131) | Delayed-release DMF TID (n = 126) | |
---|---|---|---|
Whole brain | |||
Week 24 | |||
Mean (SD) | −0.349 (1.5455) | 0.023 (1.3518) | 0.203 (1.4156) |
Median (min, max) | −0.320 (−5.03, 3.70) | 0.040 (−4.61, 4.94) | 0.345 (−4.38, 5.59) |
p value | 0.0481 | 0.0031 | |
1 year (week 48) | |||
Mean (SD) | −0.440 (1.4960) | 0.149 (1.4519) | 0.228 (1.4753) |
Median (min, max) | −0.440 (−5.21, 2.94) | 0.149 (−3.88, 4.43) | 0.228 (−4.36, 4.51) |
p value | 0.0015 | 0.0003 | |
2 years (week 96) | |||
Mean (SD) | −0.386 (1.2596) | 0.129 (1.4681) | 0.096 (1.4151) |
Median (min, max) | −0.386 (−4.72, 3.89) | 0.129 (−4.47, 4.91) | 0.096 (−4.53, 3.58) |
p value | 0.0027 | 0.0051 | |
Normal-appearing brain tissue | |||
Week 24 | |||
Mean (SD) | −0.318 (1.5401) | 0.066 (1.2718) | 0.227 (1.3849) |
Median (min, max) | −0.300 (−5.49, 3.44) | 0.050 (−4.55, 4.09) | 0.227 (−3.44, 5.13) |
p value | 0.0352 | 0.0027 | |
1 year (week 48) | |||
Mean (SD) | −0.395 (1.4719) | 0.165 (1.4297) | 0.158 (1.4540) |
Median (min, max) | −0.395 (−4.91, 3.09) | 0.140 (−3.73, 4.26) | 0.158 (−4.21, 4.67) |
p value | 0.0022 | 0.0027 | |
2 years (week 96) | |||
Mean (SD) | −0.392 (1.2582) | 0.190 (1.4465) | 0.115 (1.4153) |
Median (min, max) | −0.392 (−4.29, 3.75) | 0.190 (−4.34, 4.73) | 0.115 (−4.54, 3.88) |
p value | 0.0006 | 0.0029 |
Placebo (n = 38) | Delayed-release DMF BID (n = 58) | Delayed-release DMF TID (n = 51) | |
---|---|---|---|
Whole brain | |||
Week 24 | |||
Mean (SD) | −0.414 (1.7323) | 0.280 (1.3531) | 0.401 (1.4342) |
Median (min, max) | −0.245 (−5.03, 3.14) | 0.145 (−2.15, 4.94) | 0.490 (−2.49, 5.59) |
p value | 0.0397 | 0.0134 | |
1 year (week 48) | |||
Mean (SD) | −0.506 (1.6290) | 0.454 (1.4477) | 0.010 (1.2762) |
Median (min, max) | −0.415 (−5.21, 1.85) | 0.305 (−2.28, 4.43) | 0.228 (−4.36, 2.98) |
p value | 0.0019 | 0.0956 | |
2 years (week 96) | |||
Mean (SD) | −0.379 (1.5542) | 0.286 (1.4307) | 0.170 (1.2885) |
Median (min, max) | −0.386 (−4.72, 2.37) | 0.129 (−2.86, 4.91) | 0.150 (−3.92, 2.91) |
p value | 0.0293 | 0.0538 | |
Normal-appearing brain tissue | |||
Week 24 | |||
Mean (SD) | −0.299 (1.8041) | 0.294 (1.1928) | 0.390 (1.3765) |
Median (min, max) | −0.015 (−5.49, 3.29) | 0.175 (−1.78, 4.09) | 0.460 (−2.69. 5.13) |
p value | 0.0561 | 0.0247 | |
1 year (week 48) | |||
Mean (SD) | −0.413 (1.6068) | 0.434 (1.4000) | −0.017 (1.2119) |
Median (min, max) | −0.332 (−4.91, 2.09) | 0.165 (−2.45, 4.26) | 0.158 (−3.65, 2.46) |
p value | 0.0042 | 0.1768 | |
2 years (week 96) | |||
Mean (SD) | −0.312 (1.5918) | 0.314 (1.3814) | 0.171 (1.2528) |
Median (min, max) | −0.392 (−4.29, 2.52) | 0.190 (−3.03, 4.73) | 0.115 (−3.92, 2.47) |
p value | 0.0285 | 0.0644 |
Placebo (n = 62) | Delayed-release DMF BID (n = 94) | Delayed-release DMF TID (n = 82) | |
---|---|---|---|
Whole brain | |||
Week 24 | |||
Mean (SD) | −0.311 (1.7363) | 0.002 (1.2743) | 0.216 (1.4217) |
Median (min, max) | −0.329 (−5.03, 3.70) | −0.040 (−2.82, 4.94) | 0.345 (−3.80, 5.59) |
p value | 0.2298 | 0.0480 | |
1 year (week 48) | |||
Mean (SD) | −0.589 (1.7264) | 0.193 (1.4426) | 0.291 (1.5354) |
Median (min, max) | −0.440 (−5.21, 2.46) | 0.135 (−3.35, 4.40) | 0.228 (−4.36, 4.51) |
p value | 0.0028 | 0.0010 | |
2 years (week 96) | |||
Mean (SD) | −0.347 (1.5420) | 0.232 (1.4074) | 0.096 (1.4336) |
Median (min, max) | −0.386 (−4.72, 3.89) | 0.129 (−2.85, 4.91) | 0.096 (−4.53, 3.58) |
p value | 0.0187 | 0.0869 | |
Normal-appearing brain tissue | |||
Week 24 | |||
Mean (SD) | −0.323 (1.7329) | 0.079 (1.2199) | 0.213 (1.3607) |
Median (min, max) | −0.254 (−5.49, 3.44) | 0.025 (−2.69, 4.09) | 0.227 (−3.24, 5.13) |
p value | 0.1054 | 0.0380 | |
1 year (week 48) | |||
Mean (SD) | −0.577 (1.6634) | 0.194 (1.4615) | 0.224 (1.5007) |
Median (min, max) | −0.395 (−4.91, 3.09) | 0.075 (−3.04, 4.26) | 0.158 (−4.21, 4.67) |
p value | 0.0026 | 0.0023 | |
2 years (week 96) | |||
Mean (SD) | −0.303 (1.4566) | 0.286 (1.3860) | 0.096 (1.4318) |
Median (min, max) | −0.392 (−4.29, 3.75) | 0.190 (−2.84, 4.73) | 0.115 (−4.54, 3.88) |
p value | 0.0129 | 0.1057 |