Characteristics | Total number of patients | Patients treated with cannabinoid oromucosal spray | Patientsnottreated with cannabinoid oromucosal spray |
---|---|---|---|
n = 87 | n = 36 | n = 51 | |
Socio-demographic data | |||
Age M ± SD (range) | 50.2 ± 10.4 (27-73) | 51.1 ± 11.3 (27-73) | 49.5 ± 9.8 (28-71) |
Gender (female) n (%) | 54 (62.1) | 20 (55.6) | 34 (66.7) |
Employed* n (%) | 26 (30.2)* | 10 (27.8) | 16 (32.0)* |
Living situation* | Â | Â | Â |
 Alone n (%) | 16 (18.6) | 7 (19.4) | 9 (18.0) |
 with family/ partner n (%) | 67 (77.9) | 27 (75.0) | 40 (80.0) |
 Nursing home n (%) | 1 (1.2) | 0 (0.0) | 1 (2.0) |
 Other n (%) | 2 (2.3) | 2 (5.6) | 0 (0.0) |
Clinical data | |||
Parameters physician report | |||
Duration of multiple sclerosis in years since onset M ± SD (range) | 13.6 ± 8.4* (0.2-36) | 14.3 ± 8.9 (3-36) | 13.1 ± 8.1* (0.2-34) |
Type of multiple sclerosis | Â | Â | Â |
 Primary progressive n (%) | 16 (18.4) | 7 (19.4) | 9 (17.7) |
 Secondary progressive n (%) | 44 (50.6) | 15 (41.7) | 29 (56.9) |
 Relapsing remitting n (%) | 27 (31.0) | 14 (38.9) | 13 (25.5) |
Mean number of MS relapses in the last 12 months M ± SD (range) | 1.4 ± 0.7 (1-4) | 1.9 ± 1.1 (2-4) | 1.1 ± 0.3 (1-2) |
Duration of spasticity in years since onset M ± SD (range) | 8.0 ± 6.6** (0.2-27) | 8.2 ± 5.6 (1.0-21) | 7.9 ± 7.4** (0.2-27) |
EDSS M ± SD (range) | 5.7 ± 1.6 (1.5-8.5) | 5.8 ± 1.7 (2.0-8.5) | 5.6 ± 1.5 (1.5-8.5) |
Type of spasticity (physician report) | Â | Â | Â |
 Persistent n (%) | 46 (52.9) | 17 (47.2) | 29 (56.9) |
 Paroxysmal n (%) | 31 (35.6) | 12 (33.3) | 19 (37.2) |
 Both n (%) | 10 (11.5) | 7 (19.5) | 3 (5.9) |
Severity of spasticity (physician report) | Â | Â | Â |
 mild n (%) | 37 (42.5) | 0 (0.0) | 37 (72.5) |
 moderate n (%) | 27 (31.0) | 21 (58.3) | 6 (11.8) |
 severe n (%) | 23 (26.5) | 15 (41.7) | 8 (15.7) |
Modified Ashworth Score M ± SD (range) | 2.3 ± 1.1*** (0-4) | 3.0 ± 0.8* (1-4) | 1.7 ± 1.0* (0-4) |
Barthel index M ± SD (range) | 71.2 ± 27.5 (0-100)**** | 71.0 ± 29.5 (0-100) | 71.7 ± 21.6 (25-95)**** |
Concomitant symptoms | Â | Â | Â |
 Fatigue n (%) | 67 (77.0) | 30 (83.3) | 37 (72.6) |
 Cognitive disorder n (%) | 21 (24.1) | 13 (36.1) | 8 (15.7) |
 Depressive mood n (%) | 18 (20.7) | 9 (25.0) | 9 (17.7) |
Mobility | Â | Â | Â |
 unaided n (%) | 29 (33.3) | 9 (25.0) | 20 (39.2) |
 crutches n (%) | 16 (18.4) | 8 (22.2) | 8 (15.7) |
 walking frame n (%) | 14 (16.1) | 3 (8.3) | 11 (21.6) |
 wheelchair n (%) | 28 (32.2) | 16 (44.5) | 12 (23.5) |
Treatment with immunomodulators in the past 12Â months n (%) | 18 (20.7) | 20 (55.6) | 43 (84.3) |
Drug treatment of MS-spasticity at inclusion n (%) | 57 (65.5) | 27 (75.0) | 30 (58.8) |
Parameters patient report | Â | Â | Â |
Level of spasticity (NRS) M ± SD (range) | 5.1 ± 2.4 (0-10) | 6.5 ± 1.7 (4-10) | 4.0 ± 2.3* (0-9) |
Level of sleep disturbances (NRS) M ± SD (range) | 3.2 ± 2.9* (0-10) | 4.3 ± 3.4 (0-10) | 2.4 ± 2.2 (0-8) |