Trial Outcomes & Findings for Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis (NCT NCT00654927)
NCT ID: NCT00654927
Last Updated: 2012-03-02
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
177 participants
Primary outcome timeframe
over 7 years (2004-2011)
Results posted on
2012-03-02
Participant Flow
Participant milestones
| Measure |
Fampridine-SR b.i.d. (Twice Daily)
All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study.
|
|---|---|
|
Overall Study
STARTED
|
177
|
|
Overall Study
COMPLETED
|
70
|
|
Overall Study
NOT COMPLETED
|
107
|
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
Baseline characteristics by cohort
| Measure |
Fampridine-SR b.i.d. (Twice Daily)
n=177 Participants
All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
174 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Age Continuous
|
51.9 years
STANDARD_DEVIATION 7.67 • n=93 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: over 7 years (2004-2011)Population: 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 b.i.d.
n=177 Participants
All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study.
|
|---|---|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients with Any AE
|
176 participants
99.4
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients with Any Serious AE
|
65 participants
36.7
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients with Any Possibly/Probably Related AE
|
102 participants
41.8
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients withdrawn due to AE
|
34 participants
15.3
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients who Died
|
5 participants
2.3
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Maximum Severity/Patients with Any TEAE -Mild
|
10 participants
8.5
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Maximum Severity/Patients with Any TEAE -Moderate
|
66 participants
38.4
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Maximum Severity/Patients with Any TEAE -Severe
|
100 participants
47.5
|
SECONDARY outcome
Timeframe: Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination VisitPopulation: ITT Population. No imputation for missing data
Outcome measures
| Measure |
Fampridine-SR b.i.d.
n=177 Participants
All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study.
|
|---|---|
|
Timed 25 Foot Walk (T25FW)
(N=153) Baseline
|
1.87 feet/second
Standard Deviation 0.94
|
|
Timed 25 Foot Walk (T25FW)
(N=1) >0-8 Weeks
|
1.98 feet/second
Standard Deviation NA
1 patient analyzed at time point therefore standard deviation not applicable
|
|
Timed 25 Foot Walk (T25FW)
(N=134) >8-16 Weeks
|
2.09 feet/second
Standard Deviation 1.03
|
|
Timed 25 Foot Walk (T25FW)
(N=141) >16-42 Weeks
|
2.02 feet/second
Standard Deviation 1.04
|
|
Timed 25 Foot Walk (T25FW)
(N=127) >42-68 Weeks
|
1.82 feet/second
Standard Deviation 0.10
|
|
Timed 25 Foot Walk (T25FW)
(N=111) >68-94 Weeks
|
1.85 feet/second
Standard Deviation 1.05
|
|
Timed 25 Foot Walk (T25FW)
(N=103) >94-120 Weeks
|
1.77 feet/second
Standard Deviation 1.05
|
|
Timed 25 Foot Walk (T25FW)
(N=92) >120-146 Weeks
|
1.88 feet/second
Standard Deviation 0.10
|
|
Timed 25 Foot Walk (T25FW)
(N=86) >146-172 Weeks
|
1.84 feet/second
Standard Deviation 1.06
|
|
Timed 25 Foot Walk (T25FW)
(N=76) >172-198 Weeks
|
1.93 feet/second
Standard Deviation 1.34
|
|
Timed 25 Foot Walk (T25FW)
(N=66) >198-224 Weeks
|
1.82 feet/second
Standard Deviation 1.07
|
|
Timed 25 Foot Walk (T25FW)
(N=56) >224-250 Weeks
|
2.05 feet/second
Standard Deviation 1.16
|
|
Timed 25 Foot Walk (T25FW)
(N=52) >250-276 Weeks
|
2.03 feet/second
Standard Deviation 1.08
|
|
Timed 25 Foot Walk (T25FW)
(N=54) >276-302 Weeks
|
1.96 feet/second
Standard Deviation 1.09
|
|
Timed 25 Foot Walk (T25FW)
(N=50) >302-328 Weeks
|
1.98 feet/second
Standard Deviation 1.12
|
|
Timed 25 Foot Walk (T25FW)
(N=10) >328-354 Weeks
|
1.89 feet/second
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: visit 1 and every clinic visitPopulation: ITT Population. No imputation for missing data
The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 7 = delighted)
Outcome measures
| Measure |
Fampridine-SR b.i.d.
n=177 Participants
All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study.
|
|---|---|
|
Subject Global Impression (SGI)
(N=176) >0-8 Weeks
|
4.79 units on a scale
Standard Deviation 0.89
|
|
Subject Global Impression (SGI)
(N=168) >8-16 Weeks
|
4.70 units on a scale
Standard Deviation 1.31
|
|
Subject Global Impression (SGI)
(N=163) >16-42 Weeks
|
4.71 units on a scale
Standard Deviation 1.09
|
|
Subject Global Impression (SGI)
(N=148) >42-68 Weeks
|
4.42 units on a scale
Standard Deviation 1.09
|
|
Subject Global Impression (SGI)
(N=137)>68-94 Weeks
|
4.67 units on a scale
Standard Deviation 1.11
|
|
Subject Global Impression (SGI)
(N=128) >94-120 Weeks
|
4.70 units on a scale
Standard Deviation 1.17
|
|
Subject Global Impression (SGI)
(N=124) >120-146 Weeks
|
4.73 units on a scale
Standard Deviation 1.21
|
|
Subject Global Impression (SGI)
(N=114) >146-172 Weeks
|
4.76 units on a scale
Standard Deviation 1.29
|
|
Subject Global Impression (SGI)
(N=102) >172-198 Weeks
|
4.84 units on a scale
Standard Deviation 1.27
|
|
Subject Global Impression (SGI)
(N=91) >198-224 Weeks
|
5.15 units on a scale
Standard Deviation 1.15
|
|
Subject Global Impression (SGI)
(N=88) >224-250 Weeks
|
5.10 units on a scale
Standard Deviation 1.29
|
|
Subject Global Impression (SGI)
(N=84) >250-276 Weeks
|
5.04 units on a scale
Standard Deviation 1.16
|
|
Subject Global Impression (SGI)
(N=81) >276-302 Weeks
|
4.91 units on a scale
Standard Deviation 1.47
|
|
Subject Global Impression (SGI)
(N=74) >302-328 Weeks
|
5.28 units on a scale
Standard Deviation 1.21
|
|
Subject Global Impression (SGI)
(N=12) >328-354 Weeks
|
5.08 units on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: visit 1 and every clinic visitPopulation: ITT Population. No imputation for missing data
The CGIC was based on the Investigator's overall impression of the patient's neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 7 = very much worse)
Outcome measures
| Measure |
Fampridine-SR b.i.d.
n=177 Participants
All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study.
|
|---|---|
|
Clinician Global Impression of Change (CGIC)
(N=176) >0-8 Weeks
|
3.37 units on a scale
Standard Deviation 0.59
|
|
Clinician Global Impression of Change (CGIC)
(N=168) >8-16 Weeks
|
3.47 units on a scale
Standard Deviation 0.97
|
|
Clinician Global Impression of Change (CGIC)
(N=163) >16-42 Weeks
|
3.60 units on a scale
Standard Deviation 0.83
|
|
Clinician Global Impression of Change (CGIC)
(N=148) >42-68 Weeks
|
3.80 units on a scale
Standard Deviation 0.89
|
|
Clinician Global Impression of Change (CGIC)
(N=137) >68-94 Weeks
|
3.83 units on a scale
Standard Deviation 0.89
|
|
Clinician Global Impression of Change (CGIC)
(N=128) >94-120 Weeks
|
3.76 units on a scale
Standard Deviation 0.89
|
|
Clinician Global Impression of Change (CGIC)
(N=124) >120-146 Weeks
|
3.70 units on a scale
Standard Deviation 0.98
|
|
Clinician Global Impression of Change (CGIC)
(N=116) >146-172 Weeks
|
3.96 units on a scale
Standard Deviation 1.05
|
|
Clinician Global Impression of Change (CGIC)
(N=102) >172-198 Weeks
|
3.89 units on a scale
Standard Deviation 0.82
|
|
Clinician Global Impression of Change (CGIC)
(N=92) >198-224 Weeks
|
3.75 units on a scale
Standard Deviation 1.02
|
|
Clinician Global Impression of Change (CGIC)
(N=87) >224-250 Weeks
|
3.79 units on a scale
Standard Deviation 0.83
|
|
Clinician Global Impression of Change (CGIC)
(N=83) >250-276 Weeks
|
3.87 units on a scale
Standard Deviation 1.11
|
|
Clinician Global Impression of Change (CGIC)
(N=80) >276-302 Weeks
|
4.29 units on a scale
Standard Deviation 1.28
|
|
Clinician Global Impression of Change (CGIC)
(N=73) >302-328 Weeks
|
4.27 units on a scale
Standard Deviation 1.34
|
|
Clinician Global Impression of Change (CGIC)
(N=13) >328-354 Weeks
|
3.81 units on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Screening visit, visit 6 and every 24 months thereafterPopulation: ITT Population. No imputation for data missing
Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death) \*EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation
Outcome measures
| Measure |
Fampridine-SR b.i.d.
n=177 Participants
All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study.
|
|---|---|
|
Expanded Disability Status Scale (EDSS)
(N=166) Baseline
|
6.04 units on a scale
Standard Deviation 1.09
|
|
Expanded Disability Status Scale (EDSS)
(N=92) >8-16 Weeks
|
6.14 units on a scale
Standard Deviation 0.91
|
|
Expanded Disability Status Scale (EDSS)
(N=114) >42-68 Weeks
|
6.26 units on a scale
Standard Deviation 1.20
|
|
Expanded Disability Status Scale (EDSS)
(N=56) >146-172 Weeks
|
6.03 units on a scale
Standard Deviation 1.31
|
Adverse Events
Fampridine-SR b.i.d. (Twice Daily)
Serious events: 65 serious events
Other events: 176 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fampridine-SR b.i.d. (Twice Daily)
n=177 participants at risk
All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.56%
1/177 • Number of events 1
|
|
Cardiac disorders
Angina Unstable
|
0.56%
1/177 • Number of events 1
|
|
Vascular disorders
Aortic Rupture
|
0.56%
1/177 • Number of events 1
|
|
Gastrointestinal disorders
Appendicitis Perforated
|
0.56%
1/177 • Number of events 1
|
|
General disorders
Asthenia
|
1.1%
2/177 • Number of events 2
|
|
Cardiac disorders
Atrial Fibrillation
|
0.56%
1/177 • Number of events 1
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.56%
1/177 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.56%
1/177 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's Disease
|
0.56%
1/177 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.56%
1/177 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
1.1%
2/177 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar Carcinoma
|
0.56%
1/177 • Number of events 1
|
|
Renal and urinary disorders
Calculus Bladder
|
0.56%
1/177 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
1.7%
3/177 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.56%
1/177 • Number of events 1
|
|
General disorders
Chest Pain
|
0.56%
1/177 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.56%
1/177 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Complex Partial Seizures
|
0.56%
1/177 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
1.1%
2/177 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.56%
1/177 • Number of events 1
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.1%
2/177 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/177 • Number of events 2
|
|
Nervous system disorders
Depressed Level of Consciousness
|
0.56%
1/177 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device Malfunction
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.56%
1/177 • Number of events 1
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.56%
1/177 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.56%
1/177 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.56%
1/177 • Number of events 1
|
|
Reproductive system and breast disorders
Endometriosis
|
0.56%
1/177 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
3/177 • Number of events 3
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.1%
2/177 • Number of events 2
|
|
Vascular disorders
Haemorrhage
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.56%
1/177 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.56%
1/177 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.56%
1/177 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.7%
3/177 • Number of events 3
|
|
Vascular disorders
Hypertension
|
0.56%
1/177 • Number of events 1
|
|
Infections and infestations
Influenza
|
1.1%
2/177 • Number of events 2
|
|
General disorders
Influenza Like Illness
|
0.56%
1/177 • Number of events 1
|
|
Infections and infestations
Kidney Infection
|
0.56%
1/177 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.56%
1/177 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.56%
1/177 • Number of events 1
|
|
Psychiatric disorders
Mania
|
0.56%
1/177 • Number of events 1
|
|
Psychiatric disorders
Mental Status Changes
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Multiple Sclerosis
|
2.8%
5/177 • Number of events 5
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
6.8%
12/177 • Number of events 15
|
|
Nervous system disorders
Muscle Spasticity
|
1.7%
3/177 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.1%
2/177 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.56%
1/177 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
0.56%
1/177 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.56%
1/177 • Number of events 1
|
|
Gastrointestinal disorders
Neurogenic Bowel
|
0.56%
1/177 • Number of events 1
|
|
General disorders
Non-Cardiac Chest Pain
|
0.56%
1/177 • Number of events 1
|
|
General disorders
Oedema Peripheral
|
0.56%
1/177 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.56%
1/177 • Number of events 1
|
|
Vascular disorders
Orthostatic Hypotension
|
0.56%
1/177 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Paraparesis
|
0.56%
1/177 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.56%
1/177 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.3%
4/177 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.56%
1/177 • Number of events 3
|
|
Infections and infestations
Postoperative Wound Infection
|
0.56%
1/177 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.56%
1/177 • Number of events 1
|
|
Infections and infestations
Prostatic Abscess
|
0.56%
1/177 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.7%
3/177 • Number of events 4
|
|
General disorders
Pyrexia
|
1.1%
2/177 • Number of events 2
|
|
Gastrointestinal disorders
Rectocele
|
0.56%
1/177 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma Stage I
|
0.56%
1/177 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
0.56%
1/177 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.56%
1/177 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.56%
1/177 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.56%
1/177 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.56%
1/177 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.3%
4/177 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.56%
1/177 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat Cancer
|
0.56%
1/177 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.56%
1/177 • Number of events 1
|
|
Injury, poisoning and procedural complications
Urethral Injury
|
0.56%
1/177 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
4.0%
7/177 • Number of events 9
|
|
Infections and infestations
Urosepsis
|
1.7%
3/177 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.56%
1/177 • Number of events 1
|
|
Eye disorders
Visual Disturbance
|
0.56%
1/177 • Number of events 1
|
|
Infections and infestations
Wound Infection
|
0.56%
1/177 • Number of events 1
|
Other adverse events
| Measure |
Fampridine-SR b.i.d. (Twice Daily)
n=177 participants at risk
All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study.
|
|---|---|
|
General disorders
Adverse Drug Reaction
|
10.7%
19/177 • Number of events 26
|
|
Psychiatric disorders
Anxiety
|
7.3%
13/177 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.2%
34/177 • Number of events 49
|
|
General disorders
Asthenia
|
18.1%
32/177 • Number of events 44
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.9%
30/177 • Number of events 48
|
|
Nervous system disorders
Balance Disorder
|
9.6%
17/177 • Number of events 24
|
|
Investigations
Blood Cholesterol Increased
|
7.3%
13/177 • Number of events 15
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
6.2%
11/177 • Number of events 14
|
|
Investigations
Blood Triglycerides Increased
|
5.1%
9/177 • Number of events 9
|
|
Infections and infestations
Bronchitis
|
5.6%
10/177 • Number of events 14
|
|
Eye disorders
Cataract
|
5.6%
10/177 • Number of events 16
|
|
Infections and infestations
Cellulitis
|
5.1%
9/177 • Number of events 12
|
|
Gastrointestinal disorders
Constipation
|
12.4%
22/177 • Number of events 30
|
|
Injury, poisoning and procedural complications
Contusion
|
11.3%
20/177 • Number of events 33
|
|
Infections and infestations
Cystitis
|
5.1%
9/177 • Number of events 14
|
|
Psychiatric disorders
Depression
|
15.8%
28/177 • Number of events 29
|
|
Gastrointestinal disorders
Diarrhoea
|
10.2%
18/177 • Number of events 24
|
|
Nervous system disorders
Dizziness
|
16.4%
29/177 • Number of events 40
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
10/177 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.9%
14/177 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.1%
9/177 • Number of events 10
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.6%
10/177 • Number of events 13
|
|
Injury, poisoning and procedural complications
Fall
|
42.4%
75/177 • Number of events 157
|
|
General disorders
Fatigue
|
22.0%
39/177 • Number of events 53
|
|
Infections and infestations
Fungal Infection
|
10.2%
18/177 • Number of events 20
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
5.6%
10/177 • Number of events 11
|
|
Nervous system disorders
Headache
|
22.6%
40/177 • Number of events 58
|
|
Vascular disorders
Hypertension
|
11.3%
20/177 • Number of events 21
|
|
Nervous system disorders
Hypoaesthesia
|
8.5%
15/177 • Number of events 19
|
|
Infections and infestations
Influenza
|
7.9%
14/177 • Number of events 17
|
|
Psychiatric disorders
Insomnia
|
29.4%
52/177 • Number of events 64
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
5.6%
10/177 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
6.2%
11/177 • Number of events 15
|
|
Renal and urinary disorders
Micturition Urgency
|
7.9%
14/177 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
14.7%
26/177 • Number of events 32
|
|
Nervous system disorders
Multiple Sclerosis
|
11.3%
20/177 • Number of events 23
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
24.3%
43/177 • Number of events 68
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
17.5%
31/177 • Number of events 40
|
|
Nervous system disorders
Muscle Spasticity
|
23.2%
41/177 • Number of events 47
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
25.4%
45/177 • Number of events 79
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
9.0%
16/177 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
13/177 • Number of events 15
|
|
Infections and infestations
Nasopharyngitis
|
13.0%
23/177 • Number of events 32
|
|
Gastrointestinal disorders
Nausea
|
13.6%
24/177 • Number of events 25
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.6%
10/177 • Number of events 11
|
|
Psychiatric disorders
Nervousness
|
5.1%
9/177 • Number of events 10
|
|
General disorders
Oedema Peripheral
|
22.6%
40/177 • Number of events 52
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.6%
10/177 • Number of events 10
|
|
General disorders
Pain
|
9.0%
16/177 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
13.6%
24/177 • Number of events 37
|
|
Nervous system disorders
Paraesthesia
|
13.0%
23/177 • Number of events 31
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
6.2%
11/177 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
9/177 • Number of events 11
|
|
General disorders
Pyrexia
|
7.9%
14/177 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.2%
18/177 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
6.2%
11/177 • Number of events 12
|
|
Infections and infestations
Sinusitis
|
6.8%
12/177 • Number of events 14
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
8.5%
15/177 • Number of events 18
|
|
Nervous system disorders
Tremor
|
8.5%
15/177 • Number of events 17
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
18.6%
33/177 • Number of events 61
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.6%
10/177 • Number of events 10
|
|
Renal and urinary disorders
Urinary Retention
|
5.1%
9/177 • Number of events 9
|
|
Infections and infestations
Urinary Tract Infection
|
47.5%
84/177 • Number of events 280
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
10/177 • Number of events 12
|
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