Trial Outcomes & Findings for Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial (NCT NCT00649792)
NCT ID: NCT00649792
Last Updated: 2012-02-28
Results Overview
All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
up to 40 months
Results posted on
2012-02-28
Participant Flow
Participant milestones
| Measure |
Fampridine-SR
Tablets, 10 mg, BID
|
|---|---|
|
Overall Study
STARTED
|
214
|
|
Overall Study
COMPLETED
|
146
|
|
Overall Study
NOT COMPLETED
|
68
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
Baseline characteristics by cohort
| Measure |
Fampridine-SR
n=214 Participants
Tablets, 10 mg, BID
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
201 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age Continuous
|
52.0 years
STANDARD_DEVIATION 9.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
201 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 40 monthsPopulation: Safety Population. No imputation for missing data
All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.
Outcome measures
| Measure |
Fampridine-SR
n=214 Participants
Tablets, 10 mg, BID
|
|---|---|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients with Any TEAE
|
205 participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients with Any Serious TEAE
|
39 participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients with Any Treatment-Related AE
|
46 participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients Withdrawn due to AE
|
7 participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients who Died
|
1 participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Maximum Severity/Paitents with Any TEAE - Mild
|
29 participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Maximum Severity/Patients with Any TEAE - Moderate
|
120 participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Maximum Severity/Patients with Any TEAE - Severe
|
56 participants
|
SECONDARY outcome
Timeframe: Week 2, 14, 26, continuing every 26 weeks until the Final VisitPopulation: ITT Population. No imputation for missing data
Outcome measures
| Measure |
Fampridine-SR
n=211 Participants
Tablets, 10 mg, BID
|
|---|---|
|
Timed 25-Foot Walk (T25FW)
(N=209) >0-8 Weeks
|
2.60 feet/seconds
Standard Deviation 0.86
|
|
Timed 25-Foot Walk (T25FW)
(N=197) >8-16 Weeks
|
2.53 feet/seconds
Standard Deviation 0.93
|
|
Timed 25-Foot Walk (T25FW)
(N=201) >16-42 Weeks
|
2.52 feet/seconds
Standard Deviation 0.96
|
|
Timed 25-Foot Walk (T25FW)
(N=172) >42-68 Weeks
|
2.46 feet/seconds
Standard Deviation 1.02
|
|
Timed 25-Foot Walk (T25FW)
(N=160) >68-94 Weeks
|
2.37 feet/seconds
Standard Deviation 1.04
|
|
Timed 25-Foot Walk (T25FW)
(N=151) >94-120 Weeks
|
2.35 feet/seconds
Standard Deviation 1.10
|
|
Timed 25-Foot Walk (T25FW)
(N=143) >120-146 Weeks
|
2.27 feet/seconds
Standard Deviation 1.06
|
|
Timed 25-Foot Walk (T25FW)
(N=33) >146-172 Weeks
|
2.17 feet/seconds
Standard Deviation 1.07
|
|
Timed 25-Foot Walk (T25FW)
(N=2) >172-198 Weeks
|
1.85 feet/seconds
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Visit 1 and every clinic visit thereafter (other than the follow-up visit)Population: ITT Population. No imputation for missing data
For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.
Outcome measures
| Measure |
Fampridine-SR
n=214 Participants
Tablets, 10 mg, BID
|
|---|---|
|
Subject Global Impression (SGI)
(N=214) >0-8 Weeks
|
4.67 1-7 scale rating
Standard Deviation 1.15
|
|
Subject Global Impression (SGI)
(N=200) >8-16 Weeks
|
4.70 1-7 scale rating
Standard Deviation 1.28
|
|
Subject Global Impression (SGI)
(N=199) >16-42 Weeks
|
4.77 1-7 scale rating
Standard Deviation 1.29
|
|
Subject Global Impression (SGI)
(N=183) >42-68 Weeks
|
5.04 1-7 scale rating
Standard Deviation 1.19
|
|
Subject Global Impression (SGI)
(N=173) >68-94 Weeks
|
4.95 1-7 scale rating
Standard Deviation 1.20
|
|
Subject Global Impression (SGI)
(N=167) >94-120 Weeks
|
4.97 1-7 scale rating
Standard Deviation 1.27
|
|
Subject Global Impression (SGI)
(N=153) >120-146 Weeks
|
5.15 1-7 scale rating
Standard Deviation 1.11
|
|
Subject Global Impression (SGI)
(N=35) >146-172 Weeks
|
4.94 1-7 scale rating
Standard Deviation 1.39
|
|
Subject Global Impression (SGI)
(N=2) >172-198 Weeks
|
5.50 1-7 scale rating
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Visit 1 and every clinic visit thereafterPopulation: ITT Population. No imputation for missing data
The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.
Outcome measures
| Measure |
Fampridine-SR
n=213 Participants
Tablets, 10 mg, BID
|
|---|---|
|
Clinician's Global Impression (CGI)
(N=213) >0-8 Weeks
|
3.38 1-7 scale rating
Standard Deviation 0.84
|
|
Clinician's Global Impression (CGI)
(N=202) >8-16 Weeks
|
3.27 1-7 scale rating
Standard Deviation 0.90
|
|
Clinician's Global Impression (CGI)
(N=208) >16-42 Weeks
|
3.48 1-7 scale rating
Standard Deviation 0.98
|
|
Clinician's Global Impression (CGI)
(N=181) >42-68 Weeks
|
3.42 1-7 scale rating
Standard Deviation 0.92
|
|
Clinician's Global Impression (CGI)
(N=172) >68-94 Weeks
|
3.58 1-7 scale rating
Standard Deviation 1.14
|
|
Clinician's Global Impression (CGI)
(N=168) >94-120 Weeks
|
3.66 1-7 scale rating
Standard Deviation 1.19
|
|
Clinician's Global Impression (CGI)
(N=154) >120-146 Weeks
|
3.65 1-7 scale rating
Standard Deviation 1.16
|
|
Clinician's Global Impression (CGI)
(N=35) >146-172 Weeks
|
3.96 1-7 scale rating
Standard Deviation 1.17
|
|
Clinician's Global Impression (CGI)
(N=2) >172-198 Weeks
|
2.50 1-7 scale rating
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)Population: ITT Population. No imputation for missing data
The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)
Outcome measures
| Measure |
Fampridine-SR
n=213 Participants
Tablets, 10 mg, BID
|
|---|---|
|
Expanded Disability Status Scale (EDSS)
(N=213) Baseline
|
5.64 0-10 rating scale
Standard Deviation 1.11
|
|
Expanded Disability Status Scale (EDSS)
(N=163) >94-120 Weeks
|
5.86 0-10 rating scale
Standard Deviation 1.05
|
Adverse Events
Fampridine-SR
Serious events: 39 serious events
Other events: 205 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fampridine-SR
n=214 participants at risk
Tablets, 10 mg, BID
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Neoplasm
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Arthritis Infective
|
0.47%
1/214 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.47%
1/214 • Number of events 1
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.93%
2/214 • Number of events 2
|
|
Hepatobiliary disorders
Cholecystitis
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Clostridium Colitis
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.47%
1/214 • Number of events 1
|
|
Psychiatric disorders
Completed Suicide
|
0.47%
1/214 • Number of events 1
|
|
Cardiac disorders
Coronary Artery Disease
|
0.47%
1/214 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device Related Infection
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.47%
1/214 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
2/214 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lumbar Puncture Headache
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
2.3%
5/214 • Number of events 6
|
|
Nervous system disorders
Muscle Spasticity
|
0.93%
2/214 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Orbital Infection
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Otitis Externa
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.47%
1/214 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.93%
2/214 • Number of events 2
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.47%
1/214 • Number of events 1
|
|
Psychiatric disorders
Suicide Attempt
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Tuberculosis
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
4/214 • Number of events 4
|
|
Infections and infestations
Urosepsis
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.47%
1/214 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.47%
1/214 • Number of events 1
|
Other adverse events
| Measure |
Fampridine-SR
n=214 participants at risk
Tablets, 10 mg, BID
|
|---|---|
|
General disorders
Adverse Drug Reaction
|
8.4%
18/214 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
33/214 • Number of events 43
|
|
General disorders
Asthenia
|
5.6%
12/214 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.7%
23/214 • Number of events 30
|
|
Nervous system disorders
Balance Disorder
|
10.7%
23/214 • Number of events 29
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
6.1%
13/214 • Number of events 15
|
|
Injury, poisoning and procedural complications
Contusion
|
14.0%
30/214 • Number of events 40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
11/214 • Number of events 11
|
|
Psychiatric disorders
Depression
|
6.5%
14/214 • Number of events 19
|
|
Nervous system disorders
Dizziness
|
11.2%
24/214 • Number of events 30
|
|
Injury, poisoning and procedural complications
Fall
|
41.1%
88/214 • Number of events 182
|
|
General disorders
Fatique
|
17.3%
37/214 • Number of events 39
|
|
Nervous system disorders
Headache
|
7.0%
15/214 • Number of events 21
|
|
Nervous system disorders
Hypoaesthesia
|
6.1%
13/214 • Number of events 13
|
|
Infections and infestations
Influenza
|
7.0%
15/214 • Number of events 17
|
|
Psychiatric disorders
Insomnia
|
7.5%
16/214 • Number of events 18
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
28.5%
61/214 • Number of events 102
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.5%
14/214 • Number of events 14
|
|
Nervous system disorders
Muscle Spasticity
|
13.6%
29/214 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
17.8%
38/214 • Number of events 48
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
21/214 • Number of events 25
|
|
Gastrointestinal disorders
Nausea
|
12.6%
27/214 • Number of events 33
|
|
General disorders
Oedema Peripheral
|
17.3%
37/214 • Number of events 43
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
13.6%
29/214 • Number of events 37
|
|
General disorders
Pyrexia
|
5.6%
12/214 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
12/214 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
6.1%
13/214 • Number of events 14
|
|
Infections and infestations
Sinusitis
|
5.1%
11/214 • Number of events 12
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
5.6%
12/214 • Number of events 13
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
14.5%
31/214 • Number of events 39
|
|
Infections and infestations
Urinary Tract Infection
|
35.0%
75/214 • Number of events 148
|
Additional Information
Andrew Blight, PhD 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