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

• Sponsor: Acorda Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00648908
• Collaborator: (none)
• Enrollment: 269
• Locations: 32
• Duration (Months): 58
• Patients Per Site: 8.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Fampridine-SR	Phase 3

Detailed Description

Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients over a long period of time.

Study Design

• Study Type: Interventional
• Actual Enrollment: 269 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Outcome Measures

Primary Outcome Measures

1. Summary of Treatment Emergent Adverse Events (TEAE). [up to 5 years]

   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.

Secondary Outcome Measures

1. Timed 25 Foot Walk (T25FW) [Week 2, 14, 26, continuing every 26 weeks until the Final Visit]

2. Subject Global Impression (SGI) [visit 1 and every clinic visit]

   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.

3. Clinician Global Impression of Change (CGIC) [visit 1 and every clinic visit]

   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.

4. Expanded Disability Status Scale (EDSS) [Screening visit, visit 6 and every 24 months thereafter]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for multiple sclerosis and received either Fampridine-SR or placebo

• subject is a man or woman with clinical definite multiple sclerosis as defined by McDonald (McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis; Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis; Annals of Neurology. 2001; 50: 121-127)

• subject must be at least 18 years of age. Any subject who is now over the age of 70 must be in good overall health in the judgment of the Investigator

• subject must be of adequate cognitive function, as judged by the Investigator, to understand and sign the IRB/REB-approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol

• subjects who are women of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.

Exclusion Criteria:

• women who are either pregnant or breastfeeding, and women of childbearing potential (defined as not surgically sterile or at least two years post menopausal) who are engaged in active heterosexual relations and, are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.

• subject discontinued prematurely from the MS-F203 study

• subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG

• subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening visit, as judged by the Investigator that would preclude entry into the study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the MS-F203 study may be used as the baseline for the current study

• subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator

• subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry white (tablet film coating))

• subject has received an investigational drug, except for Fampridine-SR or matching placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is scheduled to enroll in an investigational drug trial at any time during this study.

• subject has a history of drug or alcohol abuse within the past year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
2	USC, Keck School of Medicine Health Care Consultation Center	Los Angeles	California	United States	90033
3	UC Davis	Sacramento	California	United States	95817
4	Shepherd Center	Atlanta	Georgia	United States	30309
5	University of Chicago	Chicago	Illinois	United States	60637
6	Indiana University MS Center	Indianapolis	Indiana	United States	46202
7	Maryland Center for MS	Baltimore	Maryland	United States	21201
8	Wayne State University, Department of Neurology	Detroit	Michigan	United States	48201
9	The Schapiro Center for MS	Golden Valley	Minnesota	United States	55422
10	Washington University School of Medicine, Div. of Rehab/Neurology	St. Louis	Missouri	United States	63110
11	Advanced Neurology Specialists	Great Falls	Montana	United States	59405
12	Gimbel MS Center at Holy Name Hospital	Teaneck	New Jersey	United States	07666
13	Maimonides MS Care Center	Brooklyn	New York	United States	11219
14	Corinne Goldsmith Dickinson Center for MS	New York	New York	United States	10029
15	University of Rochester	Rochester	New York	United States	14642
16	SUNY Stony Brook	Stony Brook	New York	United States	11794
17	CMC - Neuroscience & Spine Institute, Division of Neurology	Charlotte	North Carolina	United States	28207
18	Raleigh Neurology Associates	Raleigh	North Carolina	United States	27607
19	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
20	Ohio State University MS Center	Columbus	Ohio	United States	43221
21	Oregon Health & Science University, MS Center of Oregon, UHS-42	Portland	Oregon	United States	97239
22	Thomas Jefferson University Physicians	Philadelphia	Pennsylvania	United States	19107
23	Allegheny General Hospital, Allegheny Neurological Associates	Pittsburgh	Pennsylvania	United States	15212
24	University of Texas-Houston	Houston	Texas	United States	77030
25	Neurological Research Center, Inc.	Bennington	Vermont	United States	05201
26	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
27	MS Center at Evergreen	Kirkland	Washington	United States	98034
28	Foothills Medical Center	Calgary	Alberta	Canada	T2N 2T9
29	University of British Columbia, Vancouver Coastal Health Research Institute	Vancouver	British Columbia	Canada	V6T 2B5
30	River Valley Health c/o Stan Cassidy Centre for Rehabilitation	Fredericton	New Brunswick	Canada	E3B 0C7
31	QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site	Halifax	Nova Scotia	Canada	B3H 4K4
32	Ottawa Hospital General Campus	Ottawa	Ontario	Canada	K1H 8L6

Sponsors and Collaborators

• Acorda Therapeutics

Investigators

• Study Director: Bonnie Faust, Acorda Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• (Click here for more information about Fampridine-SR clinical trials)

Publications

None provided.

• Responsible Party: Acorda Therapeutics
• ClinicalTrials.gov Identifier: NCT00648908
• Other Study ID Numbers: MS-F203EXT
• First Posted: Apr 1, 2008
• Last Update Posted: Feb 27, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Acorda Therapeutics: multiple sclerosis; MS; walking; leg strength; demyelination
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis; 4-Aminopyridine

Study Results

Participant Flow

Arm/Group Title	Fampridine-SR
Arm/Group Description	Tablets, 10mg twice daily
Period Title: Overall Study
STARTED	269
COMPLETED	154
NOT COMPLETED	115

Baseline Characteristics

Arm/Group Title	Fampridine-SR
Arm/Group Description	Tablets, 10mg twice daily
Overall Participants	269
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	256 95.2%
>=65 years	13 4.8%
Age (Years) [Mean (Standard Deviation) ]
Age (years)	52.1 (8.75)
Sex: Female, Male (Count of Participants)
Female	182 67.7%
Male	87 32.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 1.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	11 4.1%
White	251 93.3%
More than one race	3 1.1%
Unknown or Not Reported	1 0.4%

Outcome Measures

1. Primary Outcome

Title	Summary of Treatment Emergent Adverse Events (TEAE).
Description	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.
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

Safety Population. No imputation for missing data

Arm/Group Title	Fampridine-SR 10mg (Twice a Day)
Arm/Group Description
Measure Participants	269
Patients with Any TEAE	264 98.1%
Patients with Any Serious AE	94 34.9%
Patients with Any Possibly/Probably Related AE	77 28.6%
Patients Withdrawn due to AE	37 13.8%
Patients who Died	4 1.5%
Maximum Severity /Patients with Any Mild TEAE	16 5.9%
Maximum Severity /Patients with Any Moderate TEAE	137 50.9%
Maximum Severity /Patients with Any Severe TEAE	111 41.3%

2. Secondary Outcome

Title	Timed 25 Foot Walk (T25FW)
Time Frame	Week 2, 14, 26, continuing every 26 weeks until the Final Visit

Outcome Measure Data

Analysis Population Description

ITT Population. No imputation for missing data

Arm/Group Title	Fampridine-SR 10mg (Twice a Day)
Arm/Group Description
Measure Participants	267
(N=265) >0-8 Weeks	2.35 (0.96)
(N=242) >8-16 Weeks	2.27 (0.95)
(N=249) >16-42 Weeks	2.28 (1.02)
(N=222) >42-68 Weeks	2.23 (1.10)
(N=204) >68-94 Weeks	2.18 (1.05)
(N=190) >94-120 Weeks	2.15 (1.00)
(N=177) >120-146 Weeks	2.14 (1.03)
(N=156) >146-172 Weeks	2.14 (0.99)
(N=143) >172-198 Weeks	2.14 (1.06)
(N=137) >198-224 Weeks	2.15 (1.05)
(N=58) >224-250 Weeks	1.98 (1.09)
(N=7) >250-276 Weeks	1.56 (0.97)

3. Secondary Outcome

Title	Subject Global Impression (SGI)
Description	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.
Time Frame	visit 1 and every clinic visit

Outcome Measure Data

Analysis Population Description

ITT Population. No imputation for missing data

Arm/Group Title	Fampridine-SR
Arm/Group Description	Tablets, 10mg twice daily
Measure Participants	268
(N=268) >0-8 Weeks	4.85 (1.10)
(N=247) >8-16 Weeks	4.79 (1.12)
(N=247) >16-42 Weeks	4.86 (1.19)
(N=230) >42-68 Weeks	4.80 (1.28)
(N=214) >68-94 Weeks	4.95 (1.20)
(N=203) >94-120 Weeks	5.03 (1.18)
(N=191) >120-146 Weeks	5.14 (1.14)
(N=182) >146-172 Weeks	5.09 (1.05)
(N=168) >172-198 Weeks	5.13 (1.11)
(N=159) >198-224 Weeks	5.16 (1.07)
(N=77) >224-250 Weeks	5.20 (1.01)
(N=13) >250-276 Weeks	5.46 (1.13)

4. Secondary Outcome

Title	Clinician Global Impression of Change (CGIC)
Description	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.
Time Frame	visit 1 and every clinic visit

Outcome Measure Data

Analysis Population Description

ITT Population. No imputation for missing data

Arm/Group Title	Fampridine-SR
Arm/Group Description	Tablets, 10mg twice daily
Measure Participants	267
(N=267) >0-8 Weeks	3.38 (0.88)
(N=248) >8-16 Weeks	3.56 (0.98)
(N=256) >16-42 Weeks	3.55 (0.87)
(N=233) >42-68 Weeks	3.63 (0.99)
(N=215) >68-94 Weeks	3.66 (0.98)
(N=203) >94-120 Weeks	3.59 (0.99)
(N=194) >120-146 Weeks	3.69 (1.01)
(N=179) >146-172 Weeks	3.85 (1.02)
(N=167) >172-198 Weeks	3.75 (1.08)
(N=160) >198-224 Weeks	3.93 (1.13)
(N=76) >224-250 Weeks	3.97 (1.34)
(N=13) >250-276 Weeks	3.39 (1.12)

5. Secondary Outcome

Title	Expanded Disability Status Scale (EDSS)
Description	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.
Time Frame	Screening visit, visit 6 and every 24 months thereafter

Outcome Measure Data

Analysis Population Description

ITT Population. No imputation for missing data

Arm/Group Title	Fampridine-SR
Arm/Group Description	Tablets, 10mg twice daily
Measure Participants	268
(N=268) Baseline	5.78 (1.07)
(N=192) >94-120 Weeks	5.95 (1.13)
(N= 148) >198-224 Weeks	6.16 (0.94)

Adverse Events

Arm/Group Title	Fampridine-SR
Arm/Group Description	Tablets, 10mg twice daily
All Cause Mortality
	Fampridine-SR
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fampridine-SR
	Affected / at Risk (%)	# Events
Total	94/269 (34.9%)
Cardiac disorders
Acute Coronary Syndrome	1/269 (0.4%)	1
Aortic Valve Incompetence	1/269 (0.4%)	1
Atrial Fibrillation	1/269 (0.4%)	2
Cardiac Failure Congestive	1/269 (0.4%)	1
Cardiogenic Shock	1/269 (0.4%)	1
Congestive Cardiomyopathy	1/269 (0.4%)	1
Myocardial Infarction	3/269 (1.1%)	3
Nodal Rhythm	1/269 (0.4%)	1
Endocrine disorders
Hyperparathyroidism Primary	1/269 (0.4%)	1
Gastrointestinal disorders
Abdominal Pain Lower	1/269 (0.4%)	1
Aphagia	1/269 (0.4%)	1
Dysphagia	1/269 (0.4%)	1
Intestinal Obstruction	1/269 (0.4%)	2
Intestinal Perforation	1/269 (0.4%)	1
Pancreatitis	1/269 (0.4%)	1
Peritonitis	1/269 (0.4%)	1
Volvulus of Bowel	1/269 (0.4%)	1
General disorders
Asthenia	3/269 (1.1%)	3
Chest Discomfort	1/269 (0.4%)	1
Chest Pain	2/269 (0.7%)	2
Malaise	1/269 (0.4%)	1
Non-Cardiac Chest Pain	3/269 (1.1%)	3
Pyrexia	2/269 (0.7%)	2
Hepatobiliary disorders
Bile Duct Stenosis	1/269 (0.4%)	1
Cholecystitis Acute	1/269 (0.4%)	1
Cholelithiasis	3/269 (1.1%)	3
Infections and infestations
Bacterial Pyelonephritis	1/269 (0.4%)	1
Bronchitis	1/269 (0.4%)	1
Candida Sepsis	1/269 (0.4%)	1
Cellulitis	5/269 (1.9%)	6
Cellulitis Staphylococcal	1/269 (0.4%)	1
Clostridial Infection	1/269 (0.4%)	1
Clostridium Colitis	3/269 (1.1%)	3
Gastroenteritis	1/269 (0.4%)	1
Parvovirus Infection	1/269 (0.4%)	1
Pneumonia	3/269 (1.1%)	3
Postoperative Abscess	1/269 (0.4%)	1
Pyelonephritis	1/269 (0.4%)	1
Sepsis	1/269 (0.4%)	1
Septic Shock	1/269 (0.4%)	1
Urinary Tract Infection	5/269 (1.9%)	8
Urinary Tract Infection Staphylococcal	1/269 (0.4%)	1
Urosepsis	3/269 (1.1%)	3
Injury, poisoning and procedural complications
Device Failure	1/269 (0.4%)	1
Face Injury	1/269 (0.4%)	1
Fall	3/269 (1.1%)	3
Hip Fracture	3/269 (1.1%)	3
Joint Injury	1/269 (0.4%)	1
Limb Injury	1/269 (0.4%)	1
Lower Limb Fracture	2/269 (0.7%)	2
Open Wound	1/269 (0.4%)	1
Polytraumatism	1/269 (0.4%)	1
Procedural Site Reaction	1/269 (0.4%)	1
Road Traffic Accident	1/269 (0.4%)	1
Splenic Rupture	1/269 (0.4%)	1
Tibia Fracture	1/269 (0.4%)	1
Investigations
Medical Observation	1/269 (0.4%)	1
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control	1/269 (0.4%)	1
Hyponatraemia	1/269 (0.4%)	1
Obesity	1/269 (0.4%)	1
Musculoskeletal and connective tissue disorders
Arthritis	1/269 (0.4%)	1
Back Pain	2/269 (0.7%)	2
Intervertebral Disc Protrusion	2/269 (0.7%)	2
Muscle Spasms	1/269 (0.4%)	1
Muscular Weakness	3/269 (1.1%)	3
Osteoarthritis	2/269 (0.7%)	3
Rotator Cuff Syndrome	1/269 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	1/269 (0.4%)	1
Breast Cancer in Situ	1/269 (0.4%)	1
Metastatic Neoplasm	1/269 (0.4%)	1
Neoplasm	1/269 (0.4%)	1
Ovarian Adenoma	1/269 (0.4%)	1
Renal Cell Carcinoma Stage Unspecified	1/269 (0.4%)	1
Nervous system disorders
Aphonia	1/269 (0.4%)	1
Cerebral Haemorrhage	1/269 (0.4%)	1
Cervical Cord Compression	1/269 (0.4%)	1
Complex Partial Seizures	1/269 (0.4%)	1
Convulsion	3/269 (1.1%)	3
Grand Mal Convulsion	1/269 (0.4%)	1
Multiple Sclerosis Relapse	13/269 (4.8%)	19
Muscle Spasticity	1/269 (0.4%)	1
Nervous System Disorder	1/269 (0.4%)	1
Syncope	2/269 (0.7%)	2
Trigeminal Neuralgia	1/269 (0.4%)	1
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/269 (0.4%)	1
Psychiatric disorders
Affective Disorder	1/269 (0.4%)	1
Anxiety	1/269 (0.4%)	1
Bipolar I Disorder	1/269 (0.4%)	1
Completed Suicide	1/269 (0.4%)	1
Major Depression	1/269 (0.4%)	1
Suicidal Ideation	1/269 (0.4%)	1
Suicide Attempt	2/269 (0.7%)	2
Renal and urinary disorders
Menorrhagia	1/269 (0.4%)	1
Neurogenic Bladder	1/269 (0.4%)	2
Renal Failure Acute	2/269 (0.7%)	2
Vulvar Dysplasia	1/269 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration	1/269 (0.4%)	1
Pulmonary Embolism	2/269 (0.7%)	2
Respiratory Failure	1/269 (0.4%)	1
Tracheal Oedema	1/269 (0.4%)	1
Vascular disorders
Deep Vein Thrombosis	1/269 (0.4%)	1
Peripheral Vascular Disorder	1/269 (0.4%)	1
Varicose Vein Ruptured	1/1 (100%)	1
Other (Not Including Serious) Adverse Events
	Fampridine-SR
	Affected / at Risk (%)	# Events
Total	264/269 (98.1%)
Gastrointestinal disorders
Constipation	27/269 (10%)	30
Diarrhoea	28/269 (10.4%)	38
Nausea	40/269 (14.9%)	60
Vomiting	18/269 (6.7%)	24
General disorders
Adverse Drug Reaction	22/269 (8.2%)	37
Asthenia	41/269 (15.2%)	50
Fatigue	44/269 (16.4%)	56
Oedema Peripheral	53/269 (19.7%)	66
Pain	21/269 (7.8%)	24
Pyrexia	17/269 (6.3%)	22
Infections and infestations
Cellulitis	15/269 (5.6%)	20
Cystitis	28/269 (10.4%)	62
Influenza	19/269 (7.1%)	26
Nasopharyngitis	37/269 (13.8%)	56
Sinusitis	26/269 (9.7%)	45
Upper Respiratory Tract Infection	47/269 (17.5%)	70
Urinary Tract Infection	112/269 (41.6%)	319
Injury, poisoning and procedural complications
Contusion	31/269 (11.5%)	46
Fall	107/269 (39.8%)	291
Skin Laceration	17/269 (6.3%)	19
Investigations
Blood Cholesterol Increased	14/269 (5.2%)	17
White Blood Cell Count Increased	14/269 (5.2%)	17
White Blood Cells Urine Positive	15/269 (5.6%)	16
Metabolism and nutrition disorders
Hypercholesterolaemia	18/269 (6.7%)	18
Musculoskeletal and connective tissue disorders
Arthralgia	66/269 (24.5%)	93
Back Pain	45/269 (16.7%)	56
Mobility Decreased	20/269 (7.4%)	23
Muscle Spasms	34/269 (12.6%)	45
Muscular Weakness	35/269 (13%)	44
Pain In Extremity	53/269 (19.7%)	71
Shoulder Pain	19/269 (7.1%)	25
Nervous system disorders
Balance Disorder	18/269 (6.7%)	20
Dizziness	28/269 (10.4%)	35
Headache	28/269 (10.4%)	39
Hypoaesthesia	26/269 (9.7%)	35
Multiple Sclerosis	21/269 (7.8%)	24
Multiple Sclerosis Relapse	87/269 (32.3%)	160
Muscle Spasticity	42/269 (15.6%)	49
Paraesthesia	25/269 (9.3%)	36
Tremor	14/269 (5.2%)	15
Psychiatric disorders
Anxiety	16/269 (5.9%)	19
Depression	38/269 (14.1%)	50
Insomnia	40/269 (14.9%)	45
Renal and urinary disorders
Pollakiuria	15/269 (5.6%)	15
Urinary Incontinence	15/269 (5.6%)	15

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.