Trial Outcomes & Findings for Study of Oral Fampridine-SR in Multiple Sclerosis (NCT NCT00127530)
NCT ID: NCT00127530
Last Updated: 2018-09-11
Results Overview
Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Results posted on
2018-09-11
Participant Flow
Participant milestones
| Measure |
Placebo- Sugar Pill
Placebo control group
|
Fampridine-SR
10 milligram (mg) tablet twice a day (b.i.d.)
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
228
|
|
Overall Study
COMPLETED
|
71
|
207
|
|
Overall Study
NOT COMPLETED
|
1
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Oral Fampridine-SR in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo- Sugar Pill
n=72 Participants
Placebo control group
|
Fampridine-SR
n=228 Participants
10 milligram (mg) tablet twice a day (b.i.d.)
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 8.72 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
67 participants
n=5 Participants
|
211 participants
n=7 Participants
|
278 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.Population: ITT Population
Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.
Outcome measures
| Measure |
Placebo- Sugar Pill
n=72 Participants
Placebo control group
|
Fampridine-SR
n=224 Participants
10 milligram (mg) tablet twice a day (b.i.d.)
|
|---|---|---|
|
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
|
6 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Days 14, 42, 70, 98Outcome measures
Outcome data not reported
Adverse Events
Placebo- Sugar Pill
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Fampridine-SR
Serious events: 16 serious events
Other events: 191 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo- Sugar Pill
n=72 participants at risk
Placebo control group
|
Fampridine-SR
n=228 participants at risk
10 milligram (mg) tablet twice a day (b.i.d.)
|
|---|---|---|
|
Vascular disorders
Angina pectoris
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/72
|
0.88%
2/228 • Number of events 2
|
|
Infections and infestations
Viral infection
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound infection
|
0.00%
0/72
|
0.44%
1/228 • Number of events 1
|
Other adverse events
| Measure |
Placebo- Sugar Pill
n=72 participants at risk
Placebo control group
|
Fampridine-SR
n=228 participants at risk
10 milligram (mg) tablet twice a day (b.i.d.)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
asthenia
|
5.6%
4/72 • Number of events 5
|
5.7%
13/228 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/72
|
5.7%
13/228 • Number of events 14
|
|
Nervous system disorders
balance disorder
|
2.8%
2/72 • Number of events 2
|
5.7%
13/228 • Number of events 13
|
|
Nervous system disorders
dizziness
|
5.6%
4/72 • Number of events 4
|
8.3%
19/228 • Number of events 21
|
|
Injury, poisoning and procedural complications
fall
|
15.3%
11/72 • Number of events 14
|
15.8%
36/228 • Number of events 56
|
|
General disorders
fatigue
|
2.8%
2/72 • Number of events 2
|
6.1%
14/228 • Number of events 15
|
|
Nervous system disorders
headache
|
5.6%
4/72 • Number of events 4
|
5.7%
13/228 • Number of events 14
|
|
Nervous system disorders
insomnia
|
4.2%
3/72 • Number of events 3
|
8.3%
19/228 • Number of events 21
|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/72 • Number of events 3
|
6.1%
14/228 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract infection
|
9.7%
7/72 • Number of events 7
|
6.1%
14/228 • Number of events 17
|
|
Infections and infestations
Urinary Tract Infection
|
13.9%
10/72 • Number of events 11
|
13.6%
31/228 • Number of events 40
|
|
Vascular disorders
Multiple Sclerosis
|
2.8%
2/72
|
4.8%
11/228
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.6%
4/72
|
4.4%
10/228
|
|
Nervous system disorders
Paraesthesia
|
5.6%
4/72
|
4.4%
10/228
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
4/72
|
3.9%
9/228
|
Additional Information
Andrew Blight, Chief Scientific Officer
Acorda Therapeutics, Inc.
Phone: 914-347-4300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
- Publication restrictions are in place
Restriction type: OTHER