Trial Outcomes & Findings for Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis (NCT NCT00053417)
NCT ID: NCT00053417
Last Updated: 2011-08-04
Results Overview
The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
206 participants
Primary outcome timeframe
Baseline (placebo run-in period); 12-week stable dose period
Results posted on
2011-08-04
Participant Flow
Patients with clinically definite MS were recruited at clinics within the US and Canada
2-week placebo run-in
Participant milestones
| Measure |
Placebo
Placebo control
|
10 mg Fampridine Twice a Day (b.i.d.)
fampridine, oral, 10 mg administered twice daily
|
15 mg Fampridine b.i.d.
fampridine, oral, 15 mg administered twice daily
|
20 mg Fampridine b.i.d.
fampridine, oral, 20 mg administered twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
52
|
50
|
57
|
|
Overall Study
COMPLETED
|
45
|
50
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo control
|
10 mg Fampridine Twice a Day (b.i.d.)
fampridine, oral, 10 mg administered twice daily
|
15 mg Fampridine b.i.d.
fampridine, oral, 15 mg administered twice daily
|
20 mg Fampridine b.i.d.
fampridine, oral, 20 mg administered twice daily
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
5
|
|
Overall Study
Non-Compliance
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo
n=47 Participants
Placebo control
|
10 mg Fampridine Twice a Day (b.i.d.)
n=52 Participants
fampridine, oral, 10 mg administered twice daily
|
15 mg Fampridine b.i.d.
n=50 Participants
fampridine, oral, 15 mg administered twice daily
|
20 mg Fampridine b.i.d.
n=57 Participants
fampridine, oral, 20 mg administered twice daily
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
199 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Age Continuous
|
49.0 years
STANDARD_DEVIATION 8.99 • n=93 Participants
|
49.8 years
STANDARD_DEVIATION 8.34 • n=4 Participants
|
47.7 years
STANDARD_DEVIATION 8.93 • n=27 Participants
|
52.2 years
STANDARD_DEVIATION 8.33 • n=483 Participants
|
49.8 years
STANDARD_DEVIATION 8.73 • n=36 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
131 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=93 Participants
|
47 participants
n=4 Participants
|
45 participants
n=27 Participants
|
51 participants
n=483 Participants
|
185 participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
6 participants
n=483 Participants
|
21 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline (placebo run-in period); 12-week stable dose periodThe primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo control
|
10 mg Fampridine Twice a Day (b.i.d.)
n=52 Participants
fampridine, oral, 10 mg administered twice daily
|
15 mg Fampridine b.i.d.
n=50 Participants
fampridine, oral, 15 mg administered twice daily
|
20 mg Fampridine b.i.d.
n=57 Participants
fampridine, oral, 20 mg administered twice daily
|
|---|---|---|---|---|
|
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
|
1.2 percent change
Full Range 18.9 • Interval -37.6 to 60.4
|
7.5 percent change
Full Range 22.1 • Interval -38.9 to 103.0
|
9.7 percent change
Full Range 23.7 • Interval -55.5 to 97.6
|
6.9 percent change
Full Range 18.5 • Interval -40.0 to 81.4
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
10 mg Fampridine Twice a Day (b.i.d.)
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
15 mg Fampridine b.i.d.
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
20 mg Fampridine b.i.d.
Serious events: 7 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo control
|
10 mg Fampridine Twice a Day (b.i.d.)
n=52 participants at risk
fampridine, oral, 10 mg administered twice daily
|
15 mg Fampridine b.i.d.
n=50 participants at risk
fampridine, oral, 15 mg administered twice daily
|
20 mg Fampridine b.i.d.
n=57 participants at risk
fampridine, oral, 20 mg administered twice daily
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
2.1%
1/47 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/57
|
|
Nervous system disorders
Complex Partial Seizures
|
0.00%
0/47
|
0.00%
0/52
|
0.00%
0/50
|
1.8%
1/57 • Number of events 2
|
|
Nervous system disorders
Convulsion
|
0.00%
0/47
|
0.00%
0/52
|
0.00%
0/50
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/47
|
0.00%
0/52
|
0.00%
0/50
|
1.8%
1/57 • Number of events 1
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/47
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/57
|
|
Nervous system disorders
Multiple Sclerosis
|
0.00%
0/47
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
7.0%
4/57 • Number of events 4
|
|
Cardiac disorders
Myocardial Infarction
|
2.1%
1/47 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/57
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/57
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/57
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo control
|
10 mg Fampridine Twice a Day (b.i.d.)
n=52 participants at risk
fampridine, oral, 10 mg administered twice daily
|
15 mg Fampridine b.i.d.
n=50 participants at risk
fampridine, oral, 15 mg administered twice daily
|
20 mg Fampridine b.i.d.
n=57 participants at risk
fampridine, oral, 20 mg administered twice daily
|
|---|---|---|---|---|
|
General disorders
Asthenia
|
2.1%
1/47 • Number of events 1
|
19.2%
10/52 • Number of events 11
|
18.0%
9/50 • Number of events 13
|
5.3%
3/57 • Number of events 4
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/47
|
5.8%
3/52 • Number of events 3
|
8.0%
4/50 • Number of events 4
|
8.8%
5/57 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
10.6%
5/47 • Number of events 5
|
3.8%
2/52 • Number of events 4
|
20.0%
10/50 • Number of events 14
|
12.3%
7/57 • Number of events 12
|
|
Injury, poisoning and procedural complications
Fall
|
10.6%
5/47 • Number of events 7
|
19.2%
10/52 • Number of events 12
|
20.0%
10/50 • Number of events 23
|
8.8%
5/57 • Number of events 6
|
|
General disorders
Fatigue
|
10.6%
5/47 • Number of events 5
|
15.4%
8/52 • Number of events 9
|
14.0%
7/50 • Number of events 10
|
8.8%
5/57 • Number of events 10
|
|
Nervous system disorders
Headache
|
8.5%
4/47 • Number of events 4
|
11.5%
6/52 • Number of events 6
|
14.0%
7/50 • Number of events 12
|
14.0%
8/57 • Number of events 11
|
|
Psychiatric disorders
Insomnia
|
8.5%
4/47 • Number of events 4
|
9.6%
5/52 • Number of events 5
|
20.0%
10/50 • Number of events 10
|
12.3%
7/57 • Number of events 7
|
|
Nervous system disorders
Multiple Sclerosis
|
4.3%
2/47 • Number of events 3
|
1.9%
1/52 • Number of events 1
|
10.0%
5/50 • Number of events 5
|
8.8%
5/57 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.4%
3/47 • Number of events 4
|
5.8%
3/52 • Number of events 3
|
6.0%
3/50 • Number of events 3
|
5.3%
3/57 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/47 • Number of events 2
|
9.6%
5/52 • Number of events 5
|
8.0%
4/50 • Number of events 5
|
10.5%
6/57 • Number of events 7
|
|
General disorders
Oedema Peripheral
|
6.4%
3/47 • Number of events 4
|
7.7%
4/52 • Number of events 4
|
12.0%
6/50 • Number of events 8
|
5.3%
3/57 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.4%
3/47 • Number of events 3
|
1.9%
1/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
12.3%
7/57 • Number of events 13
|
|
Nervous system disorders
Paraesthesia
|
6.4%
3/47 • Number of events 4
|
7.7%
4/52 • Number of events 4
|
6.0%
3/50 • Number of events 6
|
14.0%
8/57 • Number of events 14
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.1%
1/47 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
10.5%
6/57 • Number of events 7
|
|
Infections and infestations
Urinary Tract Infection
|
4.3%
2/47 • Number of events 2
|
11.5%
6/52 • Number of events 8
|
10.0%
5/50 • Number of events 5
|
15.8%
9/57 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The INSTITUTION shall submit any such manuscript or release to the SPONSOR for comment prior to publication or release at least forty-five (45) days in advance of submission for publication. If the parties disagree concerning appropriateness of the data analysis and presentation, INSTITUTION agrees to meet with SPONSOR's representatives for the purpose of making good faith efforts to discuss and resolve any issues or disagreement.
- Publication restrictions are in place
Restriction type: OTHER