Trial Outcomes & Findings for Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial (NCT NCT00648908)
NCT ID: NCT00648908
Last Updated: 2012-02-27
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
269 participants
Primary outcome timeframe
up to 5 years
Results posted on
2012-02-27
Participant Flow
Participant milestones
| Measure |
Fampridine-SR
Tablets, 10mg twice daily
|
|---|---|
|
Overall Study
STARTED
|
269
|
|
Overall Study
COMPLETED
|
154
|
|
Overall Study
NOT COMPLETED
|
115
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial
Baseline characteristics by cohort
| Measure |
Fampridine-SR
n=269 Participants
Tablets, 10mg twice daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
256 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age Continuous
Age (years)
|
52.1 Years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
251 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsPopulation: 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 10mg (Twice a Day)
n=269 Participants
|
|---|---|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients with Any TEAE
|
264 Participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients with Any Serious AE
|
94 Participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients with Any Possibly/Probably Related AE
|
77 Participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients Withdrawn due to AE
|
37 Participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Patients who Died
|
4 Participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Maximum Severity /Patients with Any Mild TEAE
|
16 Participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Maximum Severity /Patients with Any Moderate TEAE
|
137 Participants
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
Maximum Severity /Patients with Any Severe TEAE
|
111 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 10mg (Twice a Day)
n=267 Participants
|
|---|---|
|
Timed 25 Foot Walk (T25FW)
(N=265) >0-8 Weeks
|
2.35 feet/second
Standard Deviation 0.96
|
|
Timed 25 Foot Walk (T25FW)
(N=242) >8-16 Weeks
|
2.27 feet/second
Standard Deviation 0.95
|
|
Timed 25 Foot Walk (T25FW)
(N=249) >16-42 Weeks
|
2.28 feet/second
Standard Deviation 1.02
|
|
Timed 25 Foot Walk (T25FW)
(N=222) >42-68 Weeks
|
2.23 feet/second
Standard Deviation 1.10
|
|
Timed 25 Foot Walk (T25FW)
(N=204) >68-94 Weeks
|
2.18 feet/second
Standard Deviation 1.05
|
|
Timed 25 Foot Walk (T25FW)
(N=190) >94-120 Weeks
|
2.15 feet/second
Standard Deviation 1.00
|
|
Timed 25 Foot Walk (T25FW)
(N=177) >120-146 Weeks
|
2.14 feet/second
Standard Deviation 1.03
|
|
Timed 25 Foot Walk (T25FW)
(N=156) >146-172 Weeks
|
2.14 feet/second
Standard Deviation 0.99
|
|
Timed 25 Foot Walk (T25FW)
(N=143) >172-198 Weeks
|
2.14 feet/second
Standard Deviation 1.06
|
|
Timed 25 Foot Walk (T25FW)
(N=137) >198-224 Weeks
|
2.15 feet/second
Standard Deviation 1.05
|
|
Timed 25 Foot Walk (T25FW)
(N=58) >224-250 Weeks
|
1.98 feet/second
Standard Deviation 1.09
|
|
Timed 25 Foot Walk (T25FW)
(N=7) >250-276 Weeks
|
1.56 feet/second
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: visit 1 and every clinic visitPopulation: ITT Population. No imputation for missing data
Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS). 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 10mg (Twice a Day)
n=268 Participants
|
|---|---|
|
Subject Global Impression (SGI)
(N=268) >0-8 Weeks
|
4.85 units on a scale
Standard Deviation 1.10
|
|
Subject Global Impression (SGI)
(N=247) >8-16 Weeks
|
4.79 units on a scale
Standard Deviation 1.12
|
|
Subject Global Impression (SGI)
(N=247) >16-42 Weeks
|
4.86 units on a scale
Standard Deviation 1.19
|
|
Subject Global Impression (SGI)
(N=230) >42-68 Weeks
|
4.80 units on a scale
Standard Deviation 1.28
|
|
Subject Global Impression (SGI)
(N=214) >68-94 Weeks
|
4.95 units on a scale
Standard Deviation 1.20
|
|
Subject Global Impression (SGI)
(N=203) >94-120 Weeks
|
5.03 units on a scale
Standard Deviation 1.18
|
|
Subject Global Impression (SGI)
(N=191) >120-146 Weeks
|
5.14 units on a scale
Standard Deviation 1.14
|
|
Subject Global Impression (SGI)
(N=182) >146-172 Weeks
|
5.09 units on a scale
Standard Deviation 1.05
|
|
Subject Global Impression (SGI)
(N=168) >172-198 Weeks
|
5.13 units on a scale
Standard Deviation 1.11
|
|
Subject Global Impression (SGI)
(N=159) >198-224 Weeks
|
5.16 units on a scale
Standard Deviation 1.07
|
|
Subject Global Impression (SGI)
(N=77) >224-250 Weeks
|
5.20 units on a scale
Standard Deviation 1.01
|
|
Subject Global Impression (SGI)
(N=13) >250-276 Weeks
|
5.46 units on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: visit 1 and every clinic visitPopulation: ITT Population. No imputation for missing data
Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS. 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 10mg (Twice a Day)
n=267 Participants
|
|---|---|
|
Clinician Global Impression of Change (CGIC)
(N=267) >0-8 Weeks
|
3.38 units on a scale
Standard Deviation 0.88
|
|
Clinician Global Impression of Change (CGIC)
(N=248) >8-16 Weeks
|
3.56 units on a scale
Standard Deviation 0.98
|
|
Clinician Global Impression of Change (CGIC)
(N=256) >16-42 Weeks
|
3.55 units on a scale
Standard Deviation 0.87
|
|
Clinician Global Impression of Change (CGIC)
(N=233) >42-68 Weeks
|
3.63 units on a scale
Standard Deviation 0.99
|
|
Clinician Global Impression of Change (CGIC)
(N=215) >68-94 Weeks
|
3.66 units on a scale
Standard Deviation 0.98
|
|
Clinician Global Impression of Change (CGIC)
(N=203) >94-120 Weeks
|
3.59 units on a scale
Standard Deviation 0.99
|
|
Clinician Global Impression of Change (CGIC)
(N=194) >120-146 Weeks
|
3.69 units on a scale
Standard Deviation 1.01
|
|
Clinician Global Impression of Change (CGIC)
(N=179) >146-172 Weeks
|
3.85 units on a scale
Standard Deviation 1.02
|
|
Clinician Global Impression of Change (CGIC)
(N=167) >172-198 Weeks
|
3.75 units on a scale
Standard Deviation 1.08
|
|
Clinician Global Impression of Change (CGIC)
(N=160) >198-224 Weeks
|
3.93 units on a scale
Standard Deviation 1.13
|
|
Clinician Global Impression of Change (CGIC)
(N=76) >224-250 Weeks
|
3.97 units on a scale
Standard Deviation 1.34
|
|
Clinician Global Impression of Change (CGIC)
(N=13) >250-276 Weeks
|
3.39 units on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Screening visit, visit 6 and every 24 months thereafterPopulation: ITT Population. No imputation for missing data
Each patient, based on their baseline neurological exam, are scored according to the EDSS The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable.
Outcome measures
| Measure |
Fampridine-SR 10mg (Twice a Day)
n=268 Participants
|
|---|---|
|
Expanded Disability Status Scale (EDSS)
(N=268) Baseline
|
5.78 units on a scale
Standard Deviation 1.07
|
|
Expanded Disability Status Scale (EDSS)
(N=192) >94-120 Weeks
|
5.95 units on a scale
Standard Deviation 1.13
|
|
Expanded Disability Status Scale (EDSS)
(N= 148) >198-224 Weeks
|
6.16 units on a scale
Standard Deviation 0.94
|
Adverse Events
Fampridine-SR
Serious events: 94 serious events
Other events: 264 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fampridine-SR
n=269 participants at risk
Tablets, 10mg twice daily
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.37%
1/269 • Number of events 1
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.37%
1/269 • Number of events 1
|
|
Psychiatric disorders
Affective Disorder
|
0.37%
1/269 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.37%
1/269 • Number of events 1
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.37%
1/269 • Number of events 1
|
|
Gastrointestinal disorders
Aphagia
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Aphonia
|
0.37%
1/269 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.37%
1/269 • Number of events 1
|
|
General disorders
Asthenia
|
1.1%
3/269 • Number of events 3
|
|
Cardiac disorders
Atrial Fibrillation
|
0.37%
1/269 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.74%
2/269 • Number of events 2
|
|
Infections and infestations
Bacterial Pyelonephritis
|
0.37%
1/269 • Number of events 1
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.37%
1/269 • Number of events 1
|
|
Psychiatric disorders
Bipolar I Disorder
|
0.37%
1/269 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.37%
1/269 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in Situ
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Candida Sepsis
|
0.37%
1/269 • Number of events 1
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.37%
1/269 • Number of events 1
|
|
Cardiac disorders
Cardiogenic Shock
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
1.9%
5/269 • Number of events 6
|
|
Infections and infestations
Cellulitis Staphylococcal
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Cervical Cord Compression
|
0.37%
1/269 • Number of events 1
|
|
General disorders
Chest Discomfort
|
0.37%
1/269 • Number of events 1
|
|
General disorders
Chest Pain
|
0.74%
2/269 • Number of events 2
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.37%
1/269 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
3/269 • Number of events 3
|
|
Infections and infestations
Clostridial Infection
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Clostridium Colitis
|
1.1%
3/269 • Number of events 3
|
|
Psychiatric disorders
Completed Suicide
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Complex Partial Seizures
|
0.37%
1/269 • Number of events 1
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
1.1%
3/269 • Number of events 3
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device Failure
|
0.37%
1/269 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.37%
1/269 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
3/269 • Number of events 3
|
|
Infections and infestations
Gastroenteritis
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.1%
3/269 • Number of events 3
|
|
Endocrine disorders
Hyperparathyroidism Primary
|
0.37%
1/269 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.37%
1/269 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.74%
2/269 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.37%
1/269 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.74%
2/269 • Number of events 2
|
|
Psychiatric disorders
Major Depression
|
0.37%
1/269 • Number of events 1
|
|
General disorders
Malaise
|
0.37%
1/269 • Number of events 1
|
|
Investigations
Medical Observation
|
0.37%
1/269 • Number of events 1
|
|
Renal and urinary disorders
Menorrhagia
|
0.37%
1/269 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
4.8%
13/269 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Muscle Spasticity
|
0.37%
1/269 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.1%
3/269 • Number of events 3
|
|
Cardiac disorders
Myocardial Infarction
|
1.1%
3/269 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Nervous System Disorder
|
0.37%
1/269 • Number of events 1
|
|
Renal and urinary disorders
Neurogenic Bladder
|
0.37%
1/269 • Number of events 2
|
|
Cardiac disorders
Nodal Rhythm
|
0.37%
1/269 • Number of events 1
|
|
General disorders
Non-Cardiac Chest Pain
|
1.1%
3/269 • Number of events 3
|
|
Metabolism and nutrition disorders
Obesity
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Open Wound
|
0.37%
1/269 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.74%
2/269 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Adenoma
|
0.37%
1/269 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Parvovirus Infection
|
0.37%
1/269 • Number of events 1
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.37%
1/269 • Number of events 1
|
|
Gastrointestinal disorders
Peritonitis
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.1%
3/269 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Polytraumatism
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Postoperative Abscess
|
0.37%
1/269 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural Site Reaction
|
0.37%
1/269 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.74%
2/269 • Number of events 2
|
|
Infections and infestations
Pyelonephritis
|
0.37%
1/269 • Number of events 1
|
|
General disorders
Pyrexia
|
0.74%
2/269 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma Stage Unspecified
|
0.37%
1/269 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.74%
2/269 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.37%
1/269 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Septic Shock
|
0.37%
1/269 • Number of events 1
|
|
Injury, poisoning and procedural complications
Splenic Rupture
|
0.37%
1/269 • Number of events 1
|
|
Psychiatric disorders
Suicidal Ideation
|
0.37%
1/269 • Number of events 1
|
|
Psychiatric disorders
Suicide Attempt
|
0.74%
2/269 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.74%
2/269 • Number of events 2
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.37%
1/269 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Oedema
|
0.37%
1/269 • Number of events 1
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
5/269 • Number of events 8
|
|
Infections and infestations
Urinary Tract Infection Staphylococcal
|
0.37%
1/269 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
1.1%
3/269 • Number of events 3
|
|
Vascular disorders
Varicose Vein Ruptured
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Volvulus of Bowel
|
0.37%
1/269 • Number of events 1
|
|
Renal and urinary disorders
Vulvar Dysplasia
|
0.37%
1/269 • Number of events 1
|
Other adverse events
| Measure |
Fampridine-SR
n=269 participants at risk
Tablets, 10mg twice daily
|
|---|---|
|
General disorders
Adverse Drug Reaction
|
8.2%
22/269 • Number of events 37
|
|
Psychiatric disorders
Anxiety
|
5.9%
16/269 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.5%
66/269 • Number of events 93
|
|
General disorders
Asthenia
|
15.2%
41/269 • Number of events 50
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
45/269 • Number of events 56
|
|
Nervous system disorders
Balance Disorder
|
6.7%
18/269 • Number of events 20
|
|
Investigations
Blood Cholesterol Increased
|
5.2%
14/269 • Number of events 17
|
|
Infections and infestations
Cellulitis
|
5.6%
15/269 • Number of events 20
|
|
Gastrointestinal disorders
Constipation
|
10.0%
27/269 • Number of events 30
|
|
Injury, poisoning and procedural complications
Contusion
|
11.5%
31/269 • Number of events 46
|
|
Infections and infestations
Cystitis
|
10.4%
28/269 • Number of events 62
|
|
Psychiatric disorders
Depression
|
14.1%
38/269 • Number of events 50
|
|
Gastrointestinal disorders
Diarrhoea
|
10.4%
28/269 • Number of events 38
|
|
Nervous system disorders
Dizziness
|
10.4%
28/269 • Number of events 35
|
|
Injury, poisoning and procedural complications
Fall
|
39.8%
107/269 • Number of events 291
|
|
General disorders
Fatigue
|
16.4%
44/269 • Number of events 56
|
|
Nervous system disorders
Headache
|
10.4%
28/269 • Number of events 39
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.7%
18/269 • Number of events 18
|
|
Nervous system disorders
Hypoaesthesia
|
9.7%
26/269 • Number of events 35
|
|
Infections and infestations
Influenza
|
7.1%
19/269 • Number of events 26
|
|
Psychiatric disorders
Insomnia
|
14.9%
40/269 • Number of events 45
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
7.4%
20/269 • Number of events 23
|
|
Nervous system disorders
Multiple Sclerosis
|
7.8%
21/269 • Number of events 24
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
32.3%
87/269 • Number of events 160
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
12.6%
34/269 • Number of events 45
|
|
Nervous system disorders
Muscle Spasticity
|
15.6%
42/269 • Number of events 49
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
13.0%
35/269 • Number of events 44
|
|
Infections and infestations
Nasopharyngitis
|
13.8%
37/269 • Number of events 56
|
|
Gastrointestinal disorders
Nausea
|
14.9%
40/269 • Number of events 60
|
|
General disorders
Oedema Peripheral
|
19.7%
53/269 • Number of events 66
|
|
General disorders
Pain
|
7.8%
21/269 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
19.7%
53/269 • Number of events 71
|
|
Nervous system disorders
Paraesthesia
|
9.3%
25/269 • Number of events 36
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
15/269 • Number of events 15
|
|
General disorders
Pyrexia
|
6.3%
17/269 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
7.1%
19/269 • Number of events 25
|
|
Infections and infestations
Sinusitis
|
9.7%
26/269 • Number of events 45
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
6.3%
17/269 • Number of events 19
|
|
Nervous system disorders
Tremor
|
5.2%
14/269 • Number of events 15
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
17.5%
47/269 • Number of events 70
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.6%
15/269 • Number of events 15
|
|
Infections and infestations
Urinary Tract Infection
|
41.6%
112/269 • Number of events 319
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
18/269 • Number of events 24
|
|
Investigations
White Blood Cell Count Increased
|
5.2%
14/269 • Number of events 17
|
|
Investigations
White Blood Cells Urine Positive
|
5.6%
15/269 • Number of events 16
|
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