N/A
Completed N=20
An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)
Source: ClinicalTrials.gov NCT01535664 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg — 46.01; 51.40 units on a scale — p=0.015
Summary
The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg |
46.01; 51.40 | 0.015 sig |
| PRIMARY Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg |
55.10; 54.98 | 0.434 |
| SECONDARY Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg |
45.7; 47.3 | 0.003 sig |
| SECONDARY Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg |
119.381; 129.044 | 0.006 sig |
| SECONDARY Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg |
3.42; 3.78 | <.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of multiple sclerosis
- Receiving Ampyra® consistently for at least 2 weeks prior to the screening visit
- No history of seizures except simple febrile seizures
Exclusion Criteria
- Sexually active woman of childbearing potential who is not surgically sterile, <two years post-menopause or is not using effective birth control methods
- Subject who is pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01535664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.