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Table 1 Comparison of baseline characteristics in First-HD versus TETRA-HD

From: Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease

  Before Matching Before Matchinga After Matching After Matchinga
  First-HD TETRA-HD First-HD TETRA-HD
Baseline Characteristics, Mean (SD) DTB
(n = 45)
PBO
(n = 45)
TBZ
(n = 54)
PBO
(n = 30)
p-value
Active
p-value
PBO
DTB
(n = 45)
PBO
(n = 45)
TBZ
(n = 54)
PBO
(n = 30)
p-value
Active
p-value
PBO
Age 55.4 (10.3) 52.1 (13.4) 49.4 (12.4) 48.8 (10.5) 0.009 0.231 49.4 (14.3) 48.8 (12.3) 49.4 (12.4) 48.8 (10.5) 1.000 1.000
CAG repeat length 43.4 (2.7) 44.3 (4.4) 44.9 (3.4) 44.3 (3.7) 0.013 0.972 44.9 (4.1) 45.6 (4.6) 44.9 (3.4) 44.3 (3.7) 0.997 0.219
Gender, %
 Female 51.1 37.8 61.1 63.3 0.318 0.030 45.7 43.6 61.1 63.3 0.318 0.123
 Male 48.9 62.2 38.9 36.7 0.318 0.030 54.3 56.4 38.9 36.7 0.318 0.123
Caucasian, % 100.0 84.4 92.6 96.7 0.062 0.093 100.0 80.0 92.6 96.7 0.040 0.035
UHDRS TMCb
(lower score indicates lower severity)
12.1 (2.7) 13.2 (3.5) 14.7 (3.8) 15.2 (4.4) <0.001 0.041 14.7 (2.9) 15.2 (3.7) 14.7 (3.8) 15.2 (4.4) 1.000 1.000
UHDRS TMSb
(lower score indicates lower severity)
34.1 (13.2) 38.8 (15.2) 47.0 (16.7) 44.8 (15.5) <0.001 0.099 41.4 (13.4) 46.7 (16.8) 47.0 (16.7) 44.8 (15.5) 0.201 0.677
Parkinsonism
(lower score indicates lower severity)
9.3 (4.7) 11.7 (5.6) 13.8 (5.7) 12.8 (5.1) <0.001 0.367 12.1 (5.3) 14.3 (6.0) 13.8 (5.7) 12.8 (5.1) 0.338 0.334
Gait
(lower score indicates lower severity)
1.0 (0.7) 1.3 (0.7) 1.2 (0.6) 1.0 (0.5) 0.176 0.058 1.5 (0.6) 1.5 (0.7) 1.2 (0.6) 1.0 (0.5) 0.060 0.003
Verbal fluency
(higher score reflects better cognitive ability)
25.2 (11.4) 23.3 (9.9) 18.9 (9.1) 18.7 (10.8) 0.003 0.064 20.9 (8.3) 21.6 (8.0) 18.9 (9.1) 18.7 (10.8) 0.312 0.209
Symbol digit
(higher score reflects better cognitive ability)
23.3 (8.7) 23.4 (8.1) 18.1 (11.5) 24.4 (11.3) 0.011 0.689 23.2 (9.8) 20.8 (7.8) 18.1 (11.5) 24.4 (11.3) 0.097 0.140
Stroop testc
(higher score reflects better cognitive ability)
 Color naming 48.0 (16.9) 44.5 (13.9) 42.4 (14.3) 46.7 (16.4) 0.077 0.540 43.9 (15.2) 41.8 (11.7) 42.4 (14.3) 46.7 (16.4) 0.735 0.169
 Word reading 65.9 (22.4) 55.7 (17.5) 53.8 (21.0) 56.3 (20.2) 0.006 0.896 63.1 (23.2) 52.7 (15.7) 53.8 (21.0) 56.3 (20.2) 0.224 0.419
Behavioral assessment
(lower score indicates less impairment)
12.1 (12.4) 9.6 (10.1) 7.4 (7.3) 6.6 (6.2) 0.025 0.106 9.3 (10.5) 7.8 (9.5) 7.4 (7.3) 6.6 (6.2) 0.475 0.517
Functional checklist 21.6 (3.0) 20.8 (3.0) 18.8 (4.4) 19.6 (3.8) <0.001 0.130 19.8 (3.4) 19.9 (3.0) 18.8 (4.4) 19.6 (3.8) 0.378 0.707
Independence scale
(higher score indicates greater independence)
85.0 (9.4) 82.0 (9.3) 76.9 (11.6) 80.2 (9.4) <0.001 0.414 80.3 (8.2) 79.3 (7.7) 76.9 (11.6) 80.2 (9.4) 0.172 0.670
Total functional capacity
(higher scores indicate better capacity)
9.8 (2.3) 9.2 (2.0) 8.3 (2.4) 8.6 (2.3) 0.001 0.280 8.3 (2.0) 8.6 (1.8) 8.3 (2.4) 8.6 (2.3) 1.000 1.000
Epworth Sleepiness Scale
(lower score indicates less daytime sleepiness)
4.6 (3.1) 5.4 (3.8) 3.4 (3.3) 4.4 (3.5) 0.073 0.220 6.2 (3.1) 4.8 (3.1) 3.4 (3.3) 4.4 (3.5) 0.001 0.614
Barnes Akathisia Rating Scale
(higher scores indicate more akathisia and restlessness)
1.4 (1.6) 1.2 (1.9) 0.3 (0.7) 0.2 (0.6) <0.001 0.001 0.8 (1.4) 1.0 (1.8) 0.3 (0.7) 0.2 (0.6) 0.079 0.020
UPDRS speech
(lower score indicates less impairment)
0.7 (0.8) 1.0 (0.8) 1.3 (0.6) 1.1 (0.7) <0.001 0.653 1.1 (0.7) 1.2 (0.7) 1.3 (0.6) 1.1 (0.7) 0.294 0.538
  1. DTB, deutetrabenazine, PBO placebo, SD standard deviation, TBZ tetrabenazine, TMC total maximal chorea, TMS total motor score, UHDRS Unified Huntington’s Disease Rating Scale, UPDRS Unified Parkinson's Disease Rating Scale. Bolded values indicate significant differences between the active arms (p < 0.05)
  2. a p-values are for the comparison between the respective arms (i.e. active vs active and placebo vs placebo) of the First-HD and TETRA-HD trials
  3. bIn First-HD, baseline was defined as Day 0 visit; the definition was not available in TETRA-HD
  4. cIn First-HD, the Stroop interference score was reported as the difference between the predicted and raw color–word score; however, TETRA-HD did not provide a definition of the reported Stroop interference score. It is possible that either the raw or the predicted color–word score was reported in TETRA-HD; therefore, the Stroop interference score was not included in this table