Trial Outcomes & Findings for A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis (NCT NCT01356940)
NCT ID: NCT01356940
Last Updated: 2018-10-31
Results Overview
peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
10 weeks
Results posted on
2018-10-31
Participant Flow
Participant milestones
| Measure |
Dalfampridine ER 10mg Bid- Placebo
4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo
|
Placebo-dalfampridine ER 10mg Bid
placebo tablet administered bid for four weeks followed by 2 week washout and dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
|
|---|---|---|
|
First Intervention (28 Days)
STARTED
|
22
|
21
|
|
First Intervention (28 Days)
COMPLETED
|
21
|
21
|
|
First Intervention (28 Days)
NOT COMPLETED
|
1
|
0
|
|
Washout (14 Days)
STARTED
|
21
|
21
|
|
Washout (14 Days)
COMPLETED
|
21
|
21
|
|
Washout (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (28 Days)
STARTED
|
21
|
21
|
|
Second Intervention (28 Days)
COMPLETED
|
20
|
21
|
|
Second Intervention (28 Days)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Dalfampridine ER 10mg Bid- Placebo
4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo
|
Placebo-dalfampridine ER 10mg Bid
placebo tablet administered bid for four weeks followed by 2 week washout and dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
|
|---|---|---|
|
First Intervention (28 Days)
Adverse Event
|
1
|
0
|
|
Second Intervention (28 Days)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Dalfampridine ER 10mg Bid Followed by Placebo
n=22 Participants
• Age 18-75 inclusive, Male or Female 4 week administration of dalfampridine ER 10mg bid
Group A: dalfampridine ER 10mg bid for 4 weeks, 2 week washout, then matching placebo for 4 weeks
|
Placebo Followed by Dalfampridine ER 10mg Bid
n=21 Participants
• Age 18-75 inclusive, Male or Female identical placebo tablet administered bid for four weeks
Group B: identical placebo tablet administered bid for four weeks, 2 week washout, then dalfampridine ER 10mg bid for 4 weeks
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex/Gender, Customized
female patients
|
19 participants
n=5 Participants
|
11 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Sex/Gender, Customized
male patients
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weekspeak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention
Outcome measures
| Measure |
Dalfampridine ER 10mg Bid
n=43 Participants
4 week administration of dalfampridine ER 10mg bid
dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
|
Placebo
n=42 Participants
identical placebo tablet administered bid for four weeks
placebo: identical placebo tablet administered bid for four weeks
|
|---|---|---|
|
Peak Activity Index
|
0.6 change in strides per minute
Standard Deviation 0.54
|
0.3 change in strides per minute
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: total subject population
change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks
Outcome measures
| Measure |
Dalfampridine ER 10mg Bid
n=43 Participants
4 week administration of dalfampridine ER 10mg bid
dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
|
Placebo
n=42 Participants
identical placebo tablet administered bid for four weeks
placebo: identical placebo tablet administered bid for four weeks
|
|---|---|---|
|
Stepcount
|
148.7 steps per day
Standard Deviation 222
|
128 steps per day
Standard Deviation 225
|
Adverse Events
Dalfampridine ER 10mg Bid
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dalfampridine ER 10mg Bid
n=43 participants at risk
4 week administration of dalfampridine ER 10mg bid
dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
|
Placebo
n=42 participants at risk
identical placebo tablet administered bid for four weeks
placebo: identical placebo tablet administered bid for four weeks
|
|---|---|---|
|
Nervous system disorders
worsening balance
|
4.7%
2/43 • Number of events 2
|
0.00%
0/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place