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Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: Results of open-label extensions of two Phase 3 clinical trials.

Goodman AD, Bethoux F, Brown TR, Schapiro RT, Cohen R, Marinucci LN, Henney HR, Blight AR, MS-F203, MS-F204, and Extension Study Investigato - Mult. Scler. (2015)

Bottom Line: Patients received dalfampridine-ER 10 mg twice daily; and had Timed 25-Foot Walk (T25FW) assessments at 2, 14 and 26 weeks, and then every 6 months.We had 214 patients enter MS-F204EXT and 146 complete it; for a maximum exposure of 3.3 years.No new safety signals emerged and dalfampridine-ER tolerability was consistent with the double-blind phase.

View Article: PubMed Central - PubMed

Affiliation: University of Rochester Medical Center, Rochester, NY, USA.

No MeSH data available.


Related in: MedlinePlus

Patient disposition in long-term extension studies of MS-F203 (MS-F203EXT) and MS-F204 (MS-F204EXT) participants.MS: multiple sclerosis; T25FW: Timed 25-Foot Walk.
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fig1-1352458514563591: Patient disposition in long-term extension studies of MS-F203 (MS-F203EXT) and MS-F204 (MS-F204EXT) participants.MS: multiple sclerosis; T25FW: Timed 25-Foot Walk.

Mentions: Figure 1 shows the enrollment and disposition of patients in the extension phase of the two studies. Of the 269 patients who enrolled in MS-F203EXT, 154 (57.2%) were considered study completers; and 146 (68.2%) of the 214 enrolled patients were study completers in MS-F204EXT. Completers are defined as patients whom were still on therapy at the time of study termination; withdrawal of consent was the main reason for discontinuation in both LTEs, and was 14.1% and 10.7%, respectively. Mean (± SD) treatment exposure in MS-F203EXT was 39.0 (± 18.73) months, with a median of 49.3 months and a range of 0.3–59.9 months. In MS-F204EXT, the mean treatment exposure was 26.3 (± 10.1) months, with a median of 30 months and a range of 0.3–40 months.


Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: Results of open-label extensions of two Phase 3 clinical trials.

Goodman AD, Bethoux F, Brown TR, Schapiro RT, Cohen R, Marinucci LN, Henney HR, Blight AR, MS-F203, MS-F204, and Extension Study Investigato - Mult. Scler. (2015)

Patient disposition in long-term extension studies of MS-F203 (MS-F203EXT) and MS-F204 (MS-F204EXT) participants.MS: multiple sclerosis; T25FW: Timed 25-Foot Walk.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2 - License 3
Show All Figures
getmorefigures.php?uid=PMC4561451&req=5

fig1-1352458514563591: Patient disposition in long-term extension studies of MS-F203 (MS-F203EXT) and MS-F204 (MS-F204EXT) participants.MS: multiple sclerosis; T25FW: Timed 25-Foot Walk.
Mentions: Figure 1 shows the enrollment and disposition of patients in the extension phase of the two studies. Of the 269 patients who enrolled in MS-F203EXT, 154 (57.2%) were considered study completers; and 146 (68.2%) of the 214 enrolled patients were study completers in MS-F204EXT. Completers are defined as patients whom were still on therapy at the time of study termination; withdrawal of consent was the main reason for discontinuation in both LTEs, and was 14.1% and 10.7%, respectively. Mean (± SD) treatment exposure in MS-F203EXT was 39.0 (± 18.73) months, with a median of 49.3 months and a range of 0.3–59.9 months. In MS-F204EXT, the mean treatment exposure was 26.3 (± 10.1) months, with a median of 30 months and a range of 0.3–40 months.

Bottom Line: Patients received dalfampridine-ER 10 mg twice daily; and had Timed 25-Foot Walk (T25FW) assessments at 2, 14 and 26 weeks, and then every 6 months.We had 214 patients enter MS-F204EXT and 146 complete it; for a maximum exposure of 3.3 years.No new safety signals emerged and dalfampridine-ER tolerability was consistent with the double-blind phase.

View Article: PubMed Central - PubMed

Affiliation: University of Rochester Medical Center, Rochester, NY, USA.

No MeSH data available.


Related in: MedlinePlus