Table 2.
Characteristics of the participants at month 12 of follow-up in the different treatment arms.
| Group 1 | Group 2 | p-Value * | |||||
|---|---|---|---|---|---|---|---|
| Ivermectin x1 | Ivermectin x3 | Total | Ivermectin x2 | Ivermectin x3 | Total | ||
| Status of participants at 12 months: | |||||||
| Intent-to-treat set, n (%) | 45 (23) | 49 (51) | 94 (100) | 52 (26) | 51 (26) | 103 (100) | |
| As-treated set, n (%) | 41 (91) | 39 (79.6) | 80 (85) | 49 (94.2) | 37 (72.5) | 86 (83.5) | |
| Attended last follow-up visit, n (%) | 36 (91) | 39 (79.6) | 75 (79.7) | 45 (86.5) | 43 (84.3) | 88 (85.4) | 0.139 |
| Lost to follow up, n (%) | 4 (8.8) | 5 (10.2) | 9 (9.6) | 2 (3.8) | 7 (13.7) | 9 (8.7) | 0.838 |
| Consent withdrew, n (%) | 1 (2.2) | 1 (2) | 2 (4.1) | 2 (3.8) | 0 (0) | 2 (2.0) | 0.117 |
| Death, n (%) | 4 (8.9) | 4 (8.2) | 8 (8.5) | 3 (5.8) | 1 (1.9) | 4 (3.9) | 0.235 |
| Pregnant, n (%) | 1 (2) | 0 (0) | 1 (1) | 2 (3.8) | 5 (10) | 7 (6.8) | 0.035 |
| Seizure-free during last four months, n (%) | 12 (27) | 21 (43) | 33 (35) | 31 (59) | 21 (41) | 52 (50) | 0.034 |
| Seizure frequency during last four months, median (IQR) | 2 (0–5) | 1 (0–3) | 2 (0–5) | 0 (0–2) | 0 (0–2) | 0 (0–2) | 0.016 |
| >50% seizure reduction during last four months, n (%) | 18 (40) | 27 (55.1) | 45 (47.9) | 34 (65.4) | 28 (54.9) | 62 (60.2) | 0.227 |
| Optimal adherence to AED during last four months, n (%) | 28/45 (62) | 29/49 (59) | 57 (61) | 31/51 (57) | 36/52 (77) | 67 (65) | 0.562 |
| Increased AED dose >30 mg between M0 and M12 | 21/45 (47) | 18/49 (37) | 39/94 (41) | 14/52 (27) | 12/51 (23) | 26 (24) | 0.022 |
| Switch to a different AED, n (%) | 2/45 (4) | 4/49 (8) | 6 (6) | 0/52 (0) | 3/51 (6) | 3 (3) | 0.308 |
| Physical examination: | |||||||
| Altered general state, n (%) | 5 (14) | 7 (14) | 12 (17) | 5 (10) | 8 (17) | 13 (14) | 0.582 |
| Itching, n (%) | 3 (8) | 5 (5) | 8 (9) | 0 (0) | 0 (0) | 0 | 0.003 |
| Burn scars, n (%) | 1 (3) | 2 (5) | 3 (3) | 0 (0) | 2 (4) | 2 (2) | 0.669 |
| Skin snip positivity, n (%) | 16 (44) | 7 (15) | 23 (31) | 13 (32) | 5 (11) | 18 (19) | 0.065 |
| Microfilarial density per skin snip, median (IQR) | 0 (0–3) | 0 (0–0) | 0 (0–2) | 0 (0–1) | 0 (0–0) | 0 (0–1) | 0.126 |
Group 1: OIPWE meeting the OAE criteria with ≥2 seizures/month at baseline, Group 2: OIPWE not meeting the OAE criteria or <2 seizures/month at baseline; * Fisher exact test for counts and median test for continuous variables comparing the characteristics of group 1 (Total) and 2 (Total) participants at month 12 of follow-up; IQR: Interquartile range; AED: Anti-epileptic drug.