Trial Outcomes & Findings for Study of Fampridine-SR Tablets in Multiple Sclerosis Patients (NCT NCT00483652)
NCT ID: NCT00483652
Last Updated: 2016-02-04
Results Overview
A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Results posted on
2016-02-04
Participant Flow
Patients with Multiple Sclerosis, enrolled at medical and MS clinics in USA and Canada; enrollment started 22 May 2007; last patient completed on 27 Feb 2008
Two weeks of single-blind placebo run-in to establish baseline walking speeds
Participant milestones
| Measure |
Fampridine-SR 10 mg b.i.d. Treatment
Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
|
Placebo Treatment
Placebo b.i.d. dosing for 9 weeks
|
|---|---|---|
|
Double-blind Treatment Period
STARTED
|
120
|
119
|
|
Double-blind Treatment Period
COMPLETED
|
113
|
114
|
|
Double-blind Treatment Period
NOT COMPLETED
|
7
|
5
|
|
Post-study Follow-up
STARTED
|
113
|
114
|
|
Post-study Follow-up
COMPLETED
|
113
|
114
|
|
Post-study Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fampridine-SR 10 mg b.i.d. Treatment
Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
|
Placebo Treatment
Placebo b.i.d. dosing for 9 weeks
|
|---|---|---|
|
Double-blind Treatment Period
Protocol Violation
|
2
|
1
|
|
Double-blind Treatment Period
Adverse Event
|
3
|
4
|
|
Double-blind Treatment Period
Protocol inclusion deviation
|
1
|
0
|
|
Double-blind Treatment Period
Withdrawal due to AE before study began
|
1
|
0
|
Baseline Characteristics
Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
Baseline characteristics by cohort
| Measure |
Fampridine-SR 10 mg b.i.d. Treatment
n=120 Participants
Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
|
Placebo Treatment
n=119 Participants
Placebo b.i.d. dosing for 9 weeks
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 9.83 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77Population: Modified Intention-to-Treat \[ITT\] population
A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)
Outcome measures
| Measure |
Fampridine-SR 10 mg b.i.d. Treatment
n=119 Participants
Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
|
Placebo Treatment
n=118 Participants
Placebo b.i.d. dosing for 9 weeks
|
|---|---|---|
|
Responders Based Upon the Timed 25-Foot Walk [T25FW]
|
51 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.
Outcome measures
| Measure |
Fampridine-SR 10 mg b.i.d. Treatment
n=119 Participants
Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
|
Placebo Treatment
n=118 Participants
Placebo b.i.d. dosing for 9 weeks
|
|---|---|---|
|
Change in Lower Extremity Manual Muscle Test [LEMMT]
|
0.09 units on a scale
Standard Deviation 0.219
|
0.04 units on a scale
Standard Deviation 0.253
|
Adverse Events
Fampridine-SR 10 mg b.i.d. Treatment
Serious events: 5 serious events
Other events: 103 other events
Deaths: 0 deaths
Placebo Treatment
Serious events: 3 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fampridine-SR 10 mg b.i.d. Treatment
n=120 participants at risk
Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
|
Placebo Treatment
n=119 participants at risk
Placebo b.i.d. dosing for 9 weeks
|
|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.83%
1/120 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/120 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
General disorders
Chest discomfort
|
0.00%
0/120 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.83%
1/120 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Infections and infestations
Cellulitis
|
0.83%
1/120 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Infections and infestations
Urinary tract Infection
|
0.00%
0/120 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.83%
1/120 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Syncope
|
0.83%
1/120 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Complex partial seizure
|
0.00%
0/120 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
Other adverse events
| Measure |
Fampridine-SR 10 mg b.i.d. Treatment
n=120 participants at risk
Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
|
Placebo Treatment
n=119 participants at risk
Placebo b.i.d. dosing for 9 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/120 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
2.5%
3/119 • Number of events 5 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Gastrointestinal disorders
Nausea
|
8.3%
10/120 • Number of events 10 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.5%
3/120 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Gastrointestinal disorders
Constipation
|
2.5%
3/120 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
2.5%
3/119 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
General disorders
Asthenia
|
8.3%
10/120 • Number of events 10 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
4.2%
5/119 • Number of events 5 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
General disorders
Fatigue
|
3.3%
4/120 • Number of events 4 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
3.4%
4/119 • Number of events 5 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
General disorders
Difficulty in walking
|
2.5%
3/120 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.91%
1/110 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
General disorders
Pyrexia
|
2.5%
3/120 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
General disorders
Oedema peripheral
|
1.7%
2/120 • Number of events 2 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
4.2%
5/119 • Number of events 6 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Infections and infestations
Urinary tract infection
|
17.5%
21/120 • Number of events 24 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
8.4%
10/119 • Number of events 12 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
7/120 • Number of events 10 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
6.7%
8/119 • Number of events 8 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
6/120 • Number of events 6 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
4.2%
5/119 • Number of events 6 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Infections and infestations
Gastroenteritis viral
|
4.2%
5/120 • Number of events 6 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
1.7%
2/119 • Number of events 2 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Infections and infestations
Viral infection
|
3.3%
4/120 • Number of events 4 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Infections and infestations
Sinusitis
|
0.00%
0/120 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
2.5%
3/119 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Injury, poisoning and procedural complications
Fall
|
11.7%
14/120 • Number of events 32 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
16.8%
20/119 • Number of events 35 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Injury, poisoning and procedural complications
Contusion
|
3.3%
4/120 • Number of events 4 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
5.0%
6/119 • Number of events 7 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.7%
2/120 • Number of events 2 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
3.4%
4/119 • Number of events 5 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Investigations
White blood cell count decrease
|
2.5%
3/120 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.3%
4/120 • Number of events 4 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
7/120 • Number of events 8 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
2.5%
3/119 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
6/120 • Number of events 6 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
4.2%
5/119 • Number of events 5 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
4/120 • Number of events 5 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
4/120 • Number of events 4 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
1.7%
2/119 • Number of events 2 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Headache
|
9.2%
11/120 • Number of events 13 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Dizziness
|
8.3%
10/120 • Number of events 12 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Balance disorder
|
5.8%
7/120 • Number of events 8 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
1.7%
2/119 • Number of events 2 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Paresthesia
|
5.0%
6/120 • Number of events 6 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
1.7%
2/119 • Number of events 2 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Multiple Sclerosis relapse
|
4.2%
5/120 • Number of events 6 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
3.4%
4/119 • Number of events 4 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Muscle spasticity
|
2.5%
3/120 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Sciatica
|
2.5%
3/120 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Nervous system disorders
Tremor
|
2.5%
3/120 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.00%
0/119 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Psychiatric disorders
Insomnia
|
10.0%
12/120 • Number of events 13 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
1.7%
2/119 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Renal and urinary disorders
Pollakiuria
|
3.3%
4/120 • Number of events 4 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
0.84%
1/119 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Renal and urinary disorders
Haematuria
|
0.83%
1/120 • Number of events 1 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
2.5%
3/119 • Number of events 3 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
5/120 • Number of events 5 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
3.4%
4/119 • Number of events 4 • 14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
|
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