Table 2.
Severe subgroup analyses of primary and secondary endpoints between TX and SOC arm in the mITT population*
|
| |||
|---|---|---|---|
| AGE (YEARS) | |||
|
| |||
| AGE < 65 | AGE ≥ 65 | ALL AGES | |
|
| |||
| Tremor power geometric mean, N, p-value | TX = 0.022 (N = 30) SOC = 0.082 (N = 25) p = 0.0047 |
TX = 0.021 (N = 82) SOC = 0.10 (N = 87) p < 0.0001 |
TX = 0.022 (N = 112) SOC = 0.097 (N = 112) p < 0.0001 |
|
| |||
| Improvement in BF-ADL score, N, p-value** | TX Δ = 2.18 (N = 11) SOC Δ = 1.21 (N = 19) p = 0.42 |
TX Δ = 2.21 (N = 28) SOC Δ = 0.025 (N = 47) p = 0.0096 |
TX Δ = 2.21 (N = 39) SOC Δ = 0.35 (N = 66) p = 0.0079 |
|
| |||
* Severe patients were classified as having at least one of 4 tasks which impacts eating, drinking, or writing BF-ADL task ≥3.
** Includes patients with complete BF-ADL scores from baseline and at one month.