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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 in the double-blind phase and open-label extension, by treatment allocation and dalfampridine-ER responder status in the parent study. (a) Study MS-F203EXT; (b) study MS-F204EXT. Time 0 represents the ‘Screening visit’ of the parent study; after which the double-blind phases lasted 21 weeks and 14 weeks in the two parent studies, respectively. The off-treatment periods after 14 and 21 weeks in (a) and (b), respectively, reflect the safety follow-up to the parent trials, prior to initiation of the long-term extensions.DNR: dalfampridine-ER non-responder; DR: dalfampridine-ER responder; ER: extended release; EXT: extension study; MS: multiple sclerosis; PBO: placebo.
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fig2-1352458514563591: Percent change from baseline in walking speed at each scheduled visit in the double-blind phase and open-label extension, by treatment allocation and dalfampridine-ER responder status in the parent study. (a) Study MS-F203EXT; (b) study MS-F204EXT. Time 0 represents the ‘Screening visit’ of the parent study; after which the double-blind phases lasted 21 weeks and 14 weeks in the two parent studies, respectively. The off-treatment periods after 14 and 21 weeks in (a) and (b), respectively, reflect the safety follow-up to the parent trials, prior to initiation of the long-term extensions.DNR: dalfampridine-ER non-responder; DR: dalfampridine-ER responder; ER: extended release; EXT: extension study; MS: multiple sclerosis; PBO: placebo.

Mentions: Figure 2 shows the average percent change in walking speed for the double-blind and LTE phases of MS-F203/MS-F203EXT (Figure 2(a)) and MS-F204/MS-F204EXT (Figure 2(b)), stratified by placebo group and the dalfampridine-ER responder status in the parent trials. In general, the patterns of change in walking speed over time across the double-blind and LTE phases were similar between the two studies, at comparable scheduled assessment points.


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 in the double-blind phase and open-label extension, by treatment allocation and dalfampridine-ER responder status in the parent study. (a) Study MS-F203EXT; (b) study MS-F204EXT. Time 0 represents the ‘Screening visit’ of the parent study; after which the double-blind phases lasted 21 weeks and 14 weeks in the two parent studies, respectively. The off-treatment periods after 14 and 21 weeks in (a) and (b), respectively, reflect the safety follow-up to the parent trials, prior to initiation of the long-term extensions.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

fig2-1352458514563591: Percent change from baseline in walking speed at each scheduled visit in the double-blind phase and open-label extension, by treatment allocation and dalfampridine-ER responder status in the parent study. (a) Study MS-F203EXT; (b) study MS-F204EXT. Time 0 represents the ‘Screening visit’ of the parent study; after which the double-blind phases lasted 21 weeks and 14 weeks in the two parent studies, respectively. The off-treatment periods after 14 and 21 weeks in (a) and (b), respectively, reflect the safety follow-up to the parent trials, prior to initiation of the long-term extensions.DNR: dalfampridine-ER non-responder; DR: dalfampridine-ER responder; ER: extended release; EXT: extension study; MS: multiple sclerosis; PBO: placebo.
Mentions: Figure 2 shows the average percent change in walking speed for the double-blind and LTE phases of MS-F203/MS-F203EXT (Figure 2(a)) and MS-F204/MS-F204EXT (Figure 2(b)), stratified by placebo group and the dalfampridine-ER responder status in the parent trials. In general, the patterns of change in walking speed over time across the double-blind and LTE phases were similar between the two studies, at comparable scheduled assessment points.

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