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Randomized, Placebo-controlled Crossover Study of Dalfampridine Extended-release in Transverse Myelitis
Kateryna Schwartz1, Nicholas F Wymbs1, Hwa Huang1
1Johns Hopkins University, USA.
Background:
Dalfampridine has the potential to be effective in patients with transverse myelitis (TM) as this rare disorder shares some clinical and pathogenic similarities with multiple sclerosis.
Methods:
This is a randomized, double-blind, placebo-controlled crossover study of dalfampridine extended-release (D-ER, Ampyra®). Sixteen adult study participants with monophasic TM confirmed by MRI were enrolled if their baseline timed 25-foot walking speed was between 5 and 60 seconds. Participants were randomized to receive 10 mg twice-daily doses of either D-ER or placebo control for eight weeks, then crossed over to the second arm of placebo or dalfampridine for eight weeks. The primary outcome measure was the timed 25-foot walk.
Results:
Of 16 enrolled participants, three withdrew and 13 completed the trial. Among the 13 completers, nine individuals showed an average timed walk that was faster in the D-ER arm compared to the placebo arm, but only four participants met the stricter statistical threshold to be classified as a responder. Analyses of secondary clinical outcome measures including strength, balance assessments, spasticity, and Expanded Disability Status Scale (EDSS) score showed trends toward improvement with D-ER.
Conclusions:
D-ER may be beneficial in TM to improve walking speed and other neurological functions.
Insights
Dalfampridine extended-release (D-ER) showed potential benefits for walking speed in transverse myelitis (TM) patients. While not all participants responded, trends suggested improvements in other neurological functions.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Transverse myelitis (TM) shares similarities with multiple sclerosis, suggesting potential therapeutic targets.
- Dalfampridine, a potassium channel blocker, is approved for multiple sclerosis and explored for other neurological conditions.
Purpose of the Study:
- To evaluate the efficacy of dalfampridine extended-release (D-ER) in improving walking speed in patients with transverse myelitis (TM).
Main Methods:
- A randomized, double-blind, placebo-controlled crossover study.
- Sixteen adult participants with MRI-confirmed monophasic TM and baseline walking speed limitations were enrolled.
- Participants received D-ER (10 mg twice daily) or placebo for eight weeks, followed by a crossover period.
Main Results:
- Of 13 completers, nine showed faster average walking times with D-ER versus placebo.
- Four participants met the responder criteria for statistically significant improvement in walking speed.
- Secondary outcomes indicated trends toward improvement in strength, balance, spasticity, and EDSS scores with D-ER.
Conclusions:
- Dalfampridine extended-release (D-ER) may offer benefits for improving walking speed in transverse myelitis (TM).
- Further research is warranted to confirm D-ER's efficacy and explore its impact on broader neurological functions in TM patients.
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