Dalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials
| City: |
|
Portland |
| State: |
|
Oregon |
| Zip Code: |
|
97239 |
| Conditions: |
|
Multiple Sclerosis - Fatigue |
| Purpose: |
|
Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in
people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages
the myelin insulation around nerves which slows conduction of messages from the brain to the
leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin.
Recent research indicates that imbalance in MS is in large part caused by poor conduction by
the nerves that transmit information about the position of the legs to the brain. It is
therefore likely that, by improving nerve conduction, dalfampridine will also improve
imbalance in people with MS. Dalfampridine will be administered in this study by the same
route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve
walking speed in people with MS. The proposed pilot study will examine the effects of
dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This
small pilot study will help to show if dalfampridine improves imbalance in MS and will guide
the design and implementation of a larger full scale study to definitively determine if
dalfampridine improves balance and prevents falls in people with MS.
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Age 20- 59 years,
- Able to walk at least 100m without an aide or with unilateral assistance
- Prolonged APR latencies (≥ 1SD > mean for healthy people in this age range) OR,
- Reduced balance-related activity (ABC scores ≤ 85%),
- Abnormal trunk range of motion (horizontal), trunk range of motion (frontal), turning
duration, cadence, double support time, stride length or gait cycle time (outside 1SD
of the average for healthy people in this age range)
Exclusion Criteria:
- Currently taking dalfampridine (any within the last 2 weeks),
- Cause(s) of imbalance other than MS,
- Impaired renal function (creatinine clearance ≤50mL/min),
- Seizure disorder
- Pregnancy or breast feeding
|
| NCT ID: |
|
NCT01444300 |
| Primary Contact: |
|
N/A |
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Portland, Oregon 97239
United States
Joshua Y Adams, BS
Phone: 503-220-8262
Email: Joshua.Adams2@va.gov
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 24, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|