Trial Outcomes & Findings for Dalfampridine for Imbalance in Multiple Sclerosis (NCT NCT01444300)
NCT ID: NCT01444300
Last Updated: 2014-06-16
Results Overview
Automatic Postural Response (APR) latencies will be measured by Computerized Dynamic Posturography (CDP). The restoration of balance after an unexpected movement by Computerized Dynamic Posturography relies on automated postural responses in the upper and lower legs, trunk, shoulders, and neck muscles. APR latency is the reaction- time response to movements of the support surface on which the subject stands. These responses typically occur at onset latencies of \~100 milliseconds. In response to a change, both feet-in-place and stepping strategies can be used to recover balance, with the incidence of stepping responses becoming larger as the change magnitude increases voluntary movements in human subjects.
COMPLETED
PHASE2
24 participants
Baseline to 12 weeks
2014-06-16
Participant Flow
People with MS were recruited from several MS clinics in the Portland, OR metro area from September 2011 to August 2013. 24 subjects signed the consent and were enrolled in the study.
Participant milestones
| Measure |
Dalfampridine
Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
|
Placebo
Placebo: placebo pill, twice daily, for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Dalfampridine
Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
|
Placebo
Placebo: placebo pill, twice daily, for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
Baseline Characteristics
Dalfampridine for Imbalance in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Dalfampridine
n=12 Participants
Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
|
Placebo
n=12 Participants
Placebo: placebo pill, twice daily (bid), for 12 weeks
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 8.9 • n=93 Participants
|
47.8 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
47.5 years
STANDARD_DEVIATION 9.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
MS Subtype
Relapsing Remitting MS (RRMS)
|
12 participants
n=93 Participants
|
8 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
MS Subtype
Secondary Progressive MS (SPMS)
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
MS Subtype
Primary Progressive MS (PPMS)
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksAutomatic Postural Response (APR) latencies will be measured by Computerized Dynamic Posturography (CDP). The restoration of balance after an unexpected movement by Computerized Dynamic Posturography relies on automated postural responses in the upper and lower legs, trunk, shoulders, and neck muscles. APR latency is the reaction- time response to movements of the support surface on which the subject stands. These responses typically occur at onset latencies of \~100 milliseconds. In response to a change, both feet-in-place and stepping strategies can be used to recover balance, with the incidence of stepping responses becoming larger as the change magnitude increases voluntary movements in human subjects.
Outcome measures
| Measure |
Dalfampridine
n=8 Participants
Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
|
Placebo
n=12 Participants
Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
|
|---|---|---|
|
Change in Automatic Postural Response (APR )Latency
|
5.71 milliseconds
Standard Deviation 16.2
|
4.58 milliseconds
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksThe ABC is an 11-point scale and subjects are asked to indicate personal level of confidence in doing specific activities without losing balance or becoming unsteady on a scale from 0% to 100%. The ratings are added (possible range =0 -1600) and divide by 16 to get each subject's ABC score. A high ABC score indicates a high degree of confidence and a low ABC score indicates a low degree of confidence.
Outcome measures
| Measure |
Dalfampridine
n=8 Participants
Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
|
Placebo
n=12 Participants
Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
|
|---|---|---|
|
Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores
|
1.30 Scores on a scale
Standard Deviation 9.02
|
0.41 Scores on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksOutcome measures
| Measure |
Dalfampridine
n=8 Participants
Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
|
Placebo
n=12 Participants
Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
|
|---|---|---|
|
Change in Timed 25 Foot Walking Speed
|
0.26 seconds
Standard Deviation 0.78
|
0.39 seconds
Standard Deviation 1.45
|
Adverse Events
Dalfampridine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dalfampridine
n=12 participants at risk
Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
|
Placebo
n=12 participants at risk
Placebo: placebo pill, twice daily, for 12 weeks
|
|---|---|---|
|
Nervous system disorders
Insomnia
|
33.3%
4/12 • Number of events 4
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • Number of events 5
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
16.7%
2/12 • Number of events 2
|
50.0%
6/12 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Balance problems
|
16.7%
2/12 • Number of events 2
|
33.3%
4/12 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • Number of events 3
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Itching/skin reactions
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
Additional Information
Dr. Michelle Cameron
Oregon Health & Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60