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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

Percent change from baseline in walking speed at each scheduled visit, among patients with continuous participation at approximately 2 years, by treatment allocation and dalfampridine-ER responder status in the parent study. (a) Study MS-F203EXT and (b) study MS-F204EXT. Time 0 is the ‘Screening visit’ of the parent study; the double-blind phases lasted 21 weeks and 14 weeks in these two parent studies, respectively.DNR: dalfampridine-ER non-responder; DR: dalfampridine-ER responder; ER: extended release; EXT: extension study; MS: multiple sclerosis; PBO: placebo
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fig3-1352458514563591: Percent change from baseline in walking speed at each scheduled visit, among patients with continuous participation at approximately 2 years, by treatment allocation and dalfampridine-ER responder status in the parent study. (a) Study MS-F203EXT and (b) study MS-F204EXT. Time 0 is the ‘Screening visit’ of the parent study; the double-blind phases lasted 21 weeks and 14 weeks in these two parent studies, respectively.DNR: dalfampridine-ER non-responder; DR: dalfampridine-ER responder; ER: extended release; EXT: extension study; MS: multiple sclerosis; PBO: placebo

Mentions: Changes over time in group mean data could be significantly influenced by missing data from patients whom discontinued the study. Therefore, Figure 3 presents walking speed data only for those patients with continuous participation, i.e. whom had a walking speed assessment at approximately 2 years after initiation of the parent study. In both MS-F203EXT (Figure 3(a)) and MS-F204EXT (Figure 3(b)), walking speed remained higher among the patients classified as dalfampridine-ER responders, compared with non-responders. The placebo group in the double-blind studies, consisting of both responders and non-responders, showed mean improvements in walking speed during the LTE that consistently remained greater than those in the non-responders whom were in the dalfampridine-ER group in the parent studies.


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)

Percent change from baseline in walking speed at each scheduled visit, among patients with continuous participation at approximately 2 years, by treatment allocation and dalfampridine-ER responder status in the parent study. (a) Study MS-F203EXT and (b) study MS-F204EXT. Time 0 is the ‘Screening visit’ of the parent study; the double-blind phases lasted 21 weeks and 14 weeks in these two parent studies, respectively.DNR: dalfampridine-ER non-responder; DR: dalfampridine-ER responder; ER: extended release; EXT: extension study; MS: multiple sclerosis; PBO: placebo
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig3-1352458514563591: Percent change from baseline in walking speed at each scheduled visit, among patients with continuous participation at approximately 2 years, by treatment allocation and dalfampridine-ER responder status in the parent study. (a) Study MS-F203EXT and (b) study MS-F204EXT. Time 0 is the ‘Screening visit’ of the parent study; the double-blind phases lasted 21 weeks and 14 weeks in these two parent studies, respectively.DNR: dalfampridine-ER non-responder; DR: dalfampridine-ER responder; ER: extended release; EXT: extension study; MS: multiple sclerosis; PBO: placebo
Mentions: Changes over time in group mean data could be significantly influenced by missing data from patients whom discontinued the study. Therefore, Figure 3 presents walking speed data only for those patients with continuous participation, i.e. whom had a walking speed assessment at approximately 2 years after initiation of the parent study. In both MS-F203EXT (Figure 3(a)) and MS-F204EXT (Figure 3(b)), walking speed remained higher among the patients classified as dalfampridine-ER responders, compared with non-responders. The placebo group in the double-blind studies, consisting of both responders and non-responders, showed mean improvements in walking speed during the LTE that consistently remained greater than those in the non-responders whom were in the dalfampridine-ER group in the parent studies.

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