Trial Outcomes & Findings for Effects of Dalfampridine on Cognition in Multiple Sclerosis (NCT NCT02006160)
NCT ID: NCT02006160
Last Updated: 2020-10-01
Results Overview
The Symbol Digit Modalities Test is a measure of cognitive processing speed. The outcome is the total number of correct digit substitutions in 90 seconds, with a possible total range of 0-120. Higher values reflect a better score/outcome than lower scores.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
61 participants
Primary outcome timeframe
Week 0, Week 12
Results posted on
2020-10-01
Participant Flow
Participant milestones
| Measure |
Treatment
dalfampridine
dalfampridine: 10 mg bid
|
Control
placebo
placebo: 10 mg bid
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
16
|
|
Overall Study
COMPLETED
|
41
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Dalfampridine on Cognition in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Treatment
n=45 Participants
dalfampridine
dalfampridine: 10 mg bid
|
Control
n=16 Participants
placebo
placebo: 10 mg bid
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
53 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 12The Symbol Digit Modalities Test is a measure of cognitive processing speed. The outcome is the total number of correct digit substitutions in 90 seconds, with a possible total range of 0-120. Higher values reflect a better score/outcome than lower scores.
Outcome measures
| Measure |
Treatment
n=45 Participants
dalfampridine
dalfampridine: 10 mg bid
|
Control
n=16 Participants
placebo
placebo: 10 mg bid
|
|---|---|---|
|
Symbol Digit Modalities Test
Week 0
|
41.18 score on a scale
Standard Deviation 10.67
|
35.06 score on a scale
Standard Deviation 12.51
|
|
Symbol Digit Modalities Test
Week 12
|
45.05 score on a scale
Standard Deviation 11.09
|
38.63 score on a scale
Standard Deviation 10.82
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control
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 |
Treatment
n=45 participants at risk
dalfampridine
dalfampridine: 10 mg bid
|
Control
n=16 participants at risk
placebo
placebo: 10 mg bid
|
|---|---|---|
|
General disorders
Headache
|
2.2%
1/45 • Number of events 1 • From study Start to Study Completion (12 weeks per participant)
The definitions do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/16 • From study Start to Study Completion (12 weeks per participant)
The definitions do not differ from the clinicaltrials.gov definitions.
|
|
General disorders
Dizziness
|
4.4%
2/45 • Number of events 2 • From study Start to Study Completion (12 weeks per participant)
The definitions do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/16 • From study Start to Study Completion (12 weeks per participant)
The definitions do not differ from the clinicaltrials.gov definitions.
|
|
General disorders
Tremors
|
2.2%
1/45 • Number of events 1 • From study Start to Study Completion (12 weeks per participant)
The definitions do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/16 • From study Start to Study Completion (12 weeks per participant)
The definitions do not differ from the clinicaltrials.gov definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place