Table 2.
Patient disposition, n | AD/dementia | MS | Stroke/CBVD | TBI | ALS/MND | PD/movement disorders | Other PBA | Total |
---|---|---|---|---|---|---|---|---|
Enrolled | n = 17 | n = 223 | n = 51 | n = 23 | n = 199 | n = 23 | n = 17 | N = 553 |
Treated ≥6 months | 10 | 176 | 30 | 15 | 126 | 12 | 13 | 382 |
Treated ≥12 monthsa | 5 | 149 | 27 | 10 | 86 | 11 | 12 | 300 |
Completed treatment phase | 4 | 149 | 27 | 9 | 85 | 10 | 12 | 296 |
Remaining at study termination | 2 | 8 | 4 | 2 | 4 | 0 | 0 | 20 |
Did not complete due to: | 11 | 66 | 20 | 12 | 110 | 13 | 5 | 257 |
AE | 4 | 27 | 7 | 1 | 62 | 5 | 1 | 107 |
Medication refusal due to AE | 2 | 10 | 4 | 2 | 18 | 4 | 1 | 41 |
Medication refusal for other than AE | 0 | 7 | 1 | 2 | 3 | 0 | 1 | 14 |
Withdrew consent | 3 | 15 | 3 | 3 | 9 | 1 | 0 | 34 |
Lost to follow-up | 0 | 4 | 4 | 2 | 7 | 0 | 1 | 18 |
Protocol violation | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 3 |
Other | 4 | 9 | 5 | 4 | 14 | 3 | 1 | 40 |
Entered extension phase | 4 | 132 | 22 | 8 | 77 | 8 | 11 | 262 |
AD: Alzheimer’s disease; AE: adverse event; ALS: amyotrophic lateral sclerosis; CBVD: cerebrovascular disorders; MND: motor neuron disease; MS: multiple sclerosis; PBA: pseudobulbar affect; PD: Parkinson’s disease; TBI: traumatic brain injury.
aIncludes all patients who completed the treatment phase or received at least 365 days of dosing.