TABLE 1.
Demographic and essential tremor characteristics at baseline (ITT population)
| Parameter | CX‐8998 (n = 48) | Placebo (n = 47) | Total (n = 95) |
|---|---|---|---|
| Sex | |||
| Male | 25 (52%) | 25 (53%) | 50 (53%) |
| Female | 23 (48%) | 22 (47%) | 45 (47%) |
| Age at informed consent, y | |||
| Mean (SD) | 64 (9.6) | 63 (10.8) | 63 (10.2) |
| Median | 66 | 66 | 66 |
| Minimum, maximum | 28, 75 | 21, 75 | 21, 75 |
| Age group | |||
| ≤65 y | 22 (46%) | 22 (47%) | 44 (46%) |
| >65 y | 26 (54%) | 25 (53%) | 51 (54%) |
| Race | |||
| White | 45 (94%) | 46 (98%) | 91 (96%) |
| Black or African American | 3 (6%) | 1 (2%) | 4 (4%) |
| Ethnicity | |||
| Not Hispanic or Latino | 48 (100%) | 45 (96%) | 93 (98%) |
| Hispanic or Latino | 0 (0%) | 1 (2%) | 1 (1%) |
| Not reported | 0 (0%) | 1 (2%) | 1 (1%) |
| Time since onset of essential tremor, ya | |||
| Mean (SD) | 24 (16.3) | 21 (15.7) | 23 (16.0) |
| Median | 20 | 18 | 19 |
| Minimum, maximum | 3, 63 | 1, 62 | 1, 63 |
| Essential tremor improves with alcohol | |||
| Yes | 23 (48%) | 16 (34%) | 39 (41%) |
| No | 11 (23%) | 13 (28%) | 24 (25%) |
| Unknown | 14 (29%) | 18 (38%) | 32 (34%) |
| Baseline TETRAS‐PS total score (independent video rated)b | |||
| Mean (SD) | 23.1 (6.3) | 22.8 (5.7) | 22.9 (6.0) |
| Median | 22.3 | 22.5 | 22.5 |
| Minimum, maximum | 11.5, 46.5 | 12.5, 43.5 | 11.5, 46.5 |
| Baseline TETRAS‐PS total score (investigator‐rated)b | |||
| Mean (SD) | 28.4 (5.9) | 28.6 (6.4) | 28.5 (6.1) |
| Median | 27.3 | 27.5 | 27.5 |
| Minimum, maximum | 20.0, 42.5 | 19.5, 45.0 | 19.5, 45.0 |
| Baseline TETRAS‐ADL subscale scoreb | |||
| Mean (SD) | 26 (6.0) | 26 (7.0) | 26 (6.5) |
| Median | 26 | 26 | 26 |
| Minimum, maximum | 13, 38 | 9, 42 | 9, 42 |
| Baseline TETRAS total scoreb , c | |||
| Mean (SD) | 49.2 (10.6) | 48.9 (10.5) | 49.1 (10.5) |
| Median | 47.0 | 48.5 | 47.5 |
| Minimum, maximum | 28.0, 81.5 | 28.5, 85.5 | 28.0, 85.5 |
| Using primidone at screeningd | 5 (10%) | 6 (13%) | 11 (12%) |
| Antitremor medication at study entrye | 22 (46%) | 21 (45%) | 43 (45%) |
ADL, activities of daily living; ITT, intention to treat; SD, standard deviation; TETRAS, The Essential Tremor Rating Assessment Scale; TETRAS‐PS, TETRAS performance subscale (independent video rated unless otherwise noted).
Time since onset of essential tremor was estimated by subtracting age at onset of essential tremor from age at informed consent.
Baseline was defined as the last nonmissing value that was obtained before or ≤15 minutes after initiation of study drug.
TETRAS total score is sum of TETRAS‐PS subscale total score (independent video rated) and TETRAS‐ADL subscale score.
Use of primidone at screening was permitted; however, the screening period was to be extended by 2 weeks, for a total of 6 weeks, and primidone was to be discontinued.
Screening until baseline.