One patient was misidentified with cerebral palsy but was replaced by one patient who was omitted from the list. Four patients fell outside the study parameters and were excluded from the 120 identified cases. This resulted in 116 patients, of whom 59 were noted to have received Provigil at some time between January 1, 2000, and December 31, 2003. Fifty-seven patients never received Provigil during the review period.
In the Provigil-treated group, 29 of 59 patients (49%) were noted to have gait improvements. Six patients (10%) began walking or taking independent steps after starting Provigil. An additional two patients (3%) independently began standing up and walking during aqua therapy. Otherwise, they only used walkers to walk.
In the preProvigil treatment period, 19 of 59 (32%) of the Provigil-treated patients and 14 of 57 (25%) of the non-Provigil-treated patients walked independently and 18 of 59 (30%) Provigil-treated patients and 6 of 57 (11%) non-Provigil-treated patients had assisted ambulation.
In the non-Provigil-treated group, no patients began walking during the study period. Only 3 of the 57 (5%) non-Provigil-treated patients had any improvement in gait; these patients were already ambulatory at the beginning of the study, and all suffered from mild hemiplegic cerebral palsy.
In the Provigil-treated group, 29 patients (49%) had improved gait compared with 3 patients (5%) in the non-Provigil-treated group. In those patients with previous assisted or unassisted ambulation, 27 (73%) of the Provigil-treated patients showed improvement in gait. Of the remaining nonambulatory patients, 2 (9%) of the Provigil-treated patients became ambulatory compared with none in the non-Provigil-treated group. Four (22%) of 18 of the Provigil-treated patients began taking independent steps with assistance or walking without assistance during the review period compared with none in the non-Provigil-treated group. An additional 2 patients (11%) began walking independently with aqua therapy compared with none in the non-Provigil-treated group. During the review period, an improvement in every category of ambulation was noted in favor of the Provigil-treated group.