Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis

• Sponsor: Acorda Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00654927
• Collaborator: (none)
• Enrollment: 177
• Locations: 22
• Duration (Months): 89
• Patients Per Site: 8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they received active drug or placebo during their participation in the previous study.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Fampridine-SR b.i.d. (Twice Daily)	Phase 3

Detailed Description

Under the original protocol, patients were to have their treatment dose titrated upwards from a starting dose of 10mg b.i.d. to 15mg b.i.d. and then to a stable (maintenance) dose of 20mg b.i.d. The protocol was subsequently revised to lower the maximum maintenance dose. In the most current protocol, all patients were down-titrated to 10mg b.i.d. and maintained at this dose for the greater part of the duration of the study.

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: 177 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 Patients With Multiple Sclerosis
• Study Start Date: Nov 1, 2003
• 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). [over 7 years (2004-2011)]

   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) [Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit]

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

   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)

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

   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)

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

   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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• The subject must have been previously enrolled in an Acorda Therapeutics or an Elan Corporation sponsored study for multiple sclerosis and received either Fampridine or placebo.

• The subject must have multiple sclerosis as determined by the Principal Investigator.

• The subject, male or female, 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.

• The subject must be of adequate cognitive function, as judged by the Investigator.

• Any subject who is female and of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.

Exclusion Criteria:

• The subject is a female who is either pregnant or breastfeeding, or of child-bearing potential, who, if engaged in active heterosexual relations and has not had a hysterectomy or bilateral oophorectomy, would not use one of the following birth control methods: tubal ligation, implantable contraception device, oral, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.

• The subject withdrew from a previous Fampridine study because of a Serious Adverse Event that was possibly, probably or definitely related to Fampridine.

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

• The subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening Visit, as judged by the Investigator

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

• The subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine tablet

• The subject has received an investigational drug, except for Fampridine- SR (or matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit; or the subject is scheduled to enroll in an investigational drug trial at any time during this study.

• The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the Screening Visit.

• The subject has had an onset of an MS exacerbation within 30 days prior to the Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a prior exacerbation episode.

• The subject has started on a concomitant medication regimen for an underlying disease/symptom within the past 7 days; or has started an interferon or chemotherapeutic agent for multiple sclerosis within the past 4 weeks.

• The 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	Shepherd Center	Atlanta	Georgia	United States	30309
4	University of Chicago	Chicago	Illinois	United States	60637
5	Maryland Center for MS	Baltimore	Maryland	United States	21201
6	The Schapiro Center for MS	Golden Valley	Minnesota	United States	55422
7	Washington University School of Medicine, Div. of Rehab/Neurology	St. Louis	Missouri	United States	63110
8	Gimbel MS Center at Holy Name Hospital	Teaneck	New Jersey	United States	07666
9	University of Mexico, MIND Imaging Center	Albuquerque	New Mexico	United States	87131
10	Maimonides MS Care Center	Brooklyn	New York	United States	11219
11	Corinne Goldsmith Dickinson Center for MS	New York	New York	United States	10029
12	University of Rochester	Rochester	New York	United States	14642
13	SUNY Stony Brook	Stony Brook	New York	United States	11794
14	CMC - Neuroscience & Spine Institute, Division of Neurology	Charlotte	North Carolina	United States	28207
15	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
16	Ohio State University MS Center	Columbus	Ohio	United States	43221
17	Oregon Health & Science University, MS Center of Oregon, UHS-42	Portland	Oregon	United States	97239
18	Thomas Jefferson University Physicians	Philadelphia	Pennsylvania	United States	19107
19	University of Texas-Houston	Houston	Texas	United States	77030
20	MS Center at Evergreen	Kirkland	Washington	United States	98034
21	Foothills Medical Center	Calgary	Alberta	Canada	T2N 2T9
22	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1WB

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: NCT00654927
• Other Study ID Numbers: MS-F202 EXT
• First Posted: Apr 9, 2008
• Last Update Posted: Mar 2, 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 b.i.d. (Twice Daily)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	177
COMPLETED	70
NOT COMPLETED	107

Baseline Characteristics

Arm/Group Title	Fampridine-SR b.i.d. (Twice Daily)
Arm/Group Description	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 Participants	177
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	174 98.3%
>=65 years	3 1.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.9 (7.67)
Sex: Female, Male (Count of Participants)
Female	111 62.7%
Male	66 37.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 1.1%
White	171 96.6%
More than one race	4 2.3%
Unknown or Not Reported	0 0%

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	over 7 years (2004-2011)

Outcome Measure Data

Analysis Population Description

Safety Population. No imputation for missing data

Arm/Group Title	Fampridine-SR b.i.d.
Arm/Group Description	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.
Measure Participants	177
Patients with Any AE	176 (99.4) 99.4%
Patients with Any Serious AE	65 (36.7) 36.7%
Patients with Any Possibly/Probably Related AE	102 (41.8) 57.6%
Patients withdrawn due to AE	34 (15.3) 19.2%
Patients who Died	5 (2.3) 2.8%
Maximum Severity/Patients with Any TEAE -Mild	10 (8.5) 5.6%
Maximum Severity/Patients with Any TEAE -Moderate	66 (38.4) 37.3%
Maximum Severity/Patients with Any TEAE -Severe	100 (47.5) 56.5%

2. Secondary Outcome

Title	Timed 25 Foot Walk (T25FW)
Time Frame	Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit

Outcome Measure Data

Analysis Population Description

ITT Population. No imputation for missing data

Arm/Group Title	Fampridine-SR b.i.d.
Arm/Group Description	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.
Measure Participants	177
(N=153) Baseline	1.87 (0.94)
(N=1) >0-8 Weeks	1.98 (NA)
(N=134) >8-16 Weeks	2.09 (1.03)
(N=141) >16-42 Weeks	2.02 (1.04)
(N=127) >42-68 Weeks	1.82 (0.10)
(N=111) >68-94 Weeks	1.85 (1.05)
(N=103) >94-120 Weeks	1.77 (1.05)
(N=92) >120-146 Weeks	1.88 (0.10)
(N=86) >146-172 Weeks	1.84 (1.06)
(N=76) >172-198 Weeks	1.93 (1.34)
(N=66) >198-224 Weeks	1.82 (1.07)
(N=56) >224-250 Weeks	2.05 (1.16)
(N=52) >250-276 Weeks	2.03 (1.08)
(N=54) >276-302 Weeks	1.96 (1.09)
(N=50) >302-328 Weeks	1.98 (1.12)
(N=10) >328-354 Weeks	1.89 (1.57)

3. Secondary Outcome

Title	Subject Global Impression (SGI)
Description	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)
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 b.i.d.
Arm/Group Description	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.
Measure Participants	177
(N=176) >0-8 Weeks	4.79 (0.89)
(N=168) >8-16 Weeks	4.70 (1.31)
(N=163) >16-42 Weeks	4.71 (1.09)
(N=148) >42-68 Weeks	4.42 (1.09)
(N=137)>68-94 Weeks	4.67 (1.11)
(N=128) >94-120 Weeks	4.70 (1.17)
(N=124) >120-146 Weeks	4.73 (1.21)
(N=114) >146-172 Weeks	4.76 (1.29)
(N=102) >172-198 Weeks	4.84 (1.27)
(N=91) >198-224 Weeks	5.15 (1.15)
(N=88) >224-250 Weeks	5.10 (1.29)
(N=84) >250-276 Weeks	5.04 (1.16)
(N=81) >276-302 Weeks	4.91 (1.47)
(N=74) >302-328 Weeks	5.28 (1.21)
(N=12) >328-354 Weeks	5.08 (1.40)

4. Secondary Outcome

Title	Clinician Global Impression of Change (CGIC)
Description	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)
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 b.i.d.
Arm/Group Description	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.
Measure Participants	177
(N=176) >0-8 Weeks	3.37 (0.59)
(N=168) >8-16 Weeks	3.47 (0.97)
(N=163) >16-42 Weeks	3.60 (0.83)
(N=148) >42-68 Weeks	3.80 (0.89)
(N=137) >68-94 Weeks	3.83 (0.89)
(N=128) >94-120 Weeks	3.76 (0.89)
(N=124) >120-146 Weeks	3.70 (0.98)
(N=116) >146-172 Weeks	3.96 (1.05)
(N=102) >172-198 Weeks	3.89 (0.82)
(N=92) >198-224 Weeks	3.75 (1.02)
(N=87) >224-250 Weeks	3.79 (0.83)
(N=83) >250-276 Weeks	3.87 (1.11)
(N=80) >276-302 Weeks	4.29 (1.28)
(N=73) >302-328 Weeks	4.27 (1.34)
(N=13) >328-354 Weeks	3.81 (1.75)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT Population. No imputation for data missing

Arm/Group Title	Fampridine-SR b.i.d.
Arm/Group Description	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.
Measure Participants	177
(N=166) Baseline	6.04 (1.09)
(N=92) >8-16 Weeks	6.14 (0.91)
(N=114) >42-68 Weeks	6.26 (1.20)
(N=56) >146-172 Weeks	6.03 (1.31)

Adverse Events

Arm/Group Title	Fampridine-SR b.i.d. (Twice Daily)
Arm/Group Description	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.
All Cause Mortality
	Fampridine-SR b.i.d. (Twice Daily)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fampridine-SR b.i.d. (Twice Daily)
	Affected / at Risk (%)	# Events
Total	65/177 (36.7%)
Blood and lymphatic system disorders
Anaemia	1/177 (0.6%)	1
Cardiac disorders
Angina Unstable	1/177 (0.6%)	1
Atrial Fibrillation	1/177 (0.6%)	1
Myocardial Infarction	1/177 (0.6%)	1
Eye disorders
Visual Disturbance	1/177 (0.6%)	1
Gastrointestinal disorders
Appendicitis Perforated	1/177 (0.6%)	1
Constipation	1/177 (0.6%)	1
Neurogenic Bowel	1/177 (0.6%)	1
Oesophagitis	1/177 (0.6%)	1
Rectocele	1/177 (0.6%)	1
General disorders
Asthenia	2/177 (1.1%)	2
Chest Pain	1/177 (0.6%)	1
Influenza Like Illness	1/177 (0.6%)	1
Non-Cardiac Chest Pain	1/177 (0.6%)	1
Oedema Peripheral	1/177 (0.6%)	1
Pyrexia	2/177 (1.1%)	2
Hepatobiliary disorders
Cholecystitis	1/177 (0.6%)	1
Infections and infestations
Cellulitis	3/177 (1.7%)	4
Influenza	2/177 (1.1%)	2
Kidney Infection	1/177 (0.6%)	1
Pneumonia	4/177 (2.3%)	4
Postoperative Wound Infection	1/177 (0.6%)	1
Prostatic Abscess	1/177 (0.6%)	1
Sepsis	4/177 (2.3%)	4
Sinusitis	1/177 (0.6%)	1
Urinary Tract Infection	7/177 (4%)	9
Urosepsis	3/177 (1.7%)	4
Wound Infection	1/177 (0.6%)	1
Injury, poisoning and procedural complications
Back Injury	1/177 (0.6%)	1
Device Malfunction	1/177 (0.6%)	1
Drug Toxicity	1/177 (0.6%)	1
Fall	3/177 (1.7%)	3
Femur Fracture	2/177 (1.1%)	2
Hip Fracture	3/177 (1.7%)	3
Limb Injury	1/177 (0.6%)	1
Rib Fracture	1/177 (0.6%)	1
Tibia Fracture	1/177 (0.6%)	1
Urethral Injury	1/177 (0.6%)	1
Metabolism and nutrition disorders
Dehydration	2/177 (1.1%)	2
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis	1/177 (0.6%)	1
Lumbar Spinal Stenosis	1/177 (0.6%)	1
Muscular Weakness	2/177 (1.1%)	2
Musculoskeletal Chest Pain	1/177 (0.6%)	1
Osteoarthritis	1/177 (0.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer	1/177 (0.6%)	1
Bowen's Disease	1/177 (0.6%)	1
Brain Neoplasm	1/177 (0.6%)	1
Breast Cancer	2/177 (1.1%)	2
Bronchioloalveolar Carcinoma	1/177 (0.6%)	1
Colon Cancer	1/177 (0.6%)	1
Hepatic Neoplasm Malignant	1/177 (0.6%)	1
Prostate Cancer	1/177 (0.6%)	1
Renal Cell Carcinoma Stage I	1/177 (0.6%)	1
Throat Cancer	1/177 (0.6%)	1
Uterine Cancer	1/177 (0.6%)	1
Nervous system disorders
Complex Partial Seizures	1/177 (0.6%)	1
Convulsion	2/177 (1.1%)	2
Depressed Level of Consciousness	1/177 (0.6%)	1
Dizziness	1/177 (0.6%)	1
Encephalopathy	1/177 (0.6%)	1
Haemorrhage Intracranial	1/177 (0.6%)	1
Multiple Sclerosis	5/177 (2.8%)	5
Multiple Sclerosis Relapse	12/177 (6.8%)	15
Muscle Spasticity	3/177 (1.7%)	3
Paraparesis	1/177 (0.6%)	1
Syncope	1/177 (0.6%)	1
Trigeminal Neuralgia	1/177 (0.6%)	1
Psychiatric disorders
Hallucination	1/177 (0.6%)	1
Mania	1/177 (0.6%)	1
Mental Status Changes	1/177 (0.6%)	1
Renal and urinary disorders
Calculus Bladder	1/177 (0.6%)	1
Nephrolithiasis	1/177 (0.6%)	1
Renal Failure	1/177 (0.6%)	1
Renal Failure Acute	1/177 (0.6%)	1
Reproductive system and breast disorders
Endometriosis	1/177 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Dysphonia	1/177 (0.6%)	1
Dyspnoea	1/177 (0.6%)	1
Pleural Effusion	1/177 (0.6%)	1
Pneumonia Aspiration	1/177 (0.6%)	3
Pulmonary Embolism	3/177 (1.7%)	4
Respiratory Arrest	1/177 (0.6%)	1
Respiratory Distress	1/177 (0.6%)	1
Skin and subcutaneous tissue disorders
Decubitus Ulcer	1/177 (0.6%)	1
Vascular disorders
Aortic Rupture	1/177 (0.6%)	1
Deep Vein Thrombosis	2/177 (1.1%)	2
Haemorrhage	1/177 (0.6%)	1
Hypertension	1/177 (0.6%)	1
Orthostatic Hypotension	1/177 (0.6%)	1
Other (Not Including Serious) Adverse Events
	Fampridine-SR b.i.d. (Twice Daily)
	Affected / at Risk (%)	# Events
Total	176/177 (99.4%)
Ear and labyrinth disorders
Vertigo	10/177 (5.6%)	12
Eye disorders
Cataract	10/177 (5.6%)	16
Gastrointestinal disorders
Constipation	22/177 (12.4%)	30
Diarrhoea	18/177 (10.2%)	24
Dyspepsia	10/177 (5.6%)	14
Gastroesophageal Reflux Disease	10/177 (5.6%)	11
Nausea	24/177 (13.6%)	25
General disorders
Adverse Drug Reaction	19/177 (10.7%)	26
Asthenia	32/177 (18.1%)	44
Fatigue	39/177 (22%)	53
Oedema Peripheral	40/177 (22.6%)	52
Pain	16/177 (9%)	19
Pyrexia	14/177 (7.9%)	17
Infections and infestations
Bronchitis	10/177 (5.6%)	14
Cellulitis	9/177 (5.1%)	12
Cystitis	9/177 (5.1%)	14
Fungal Infection	18/177 (10.2%)	20
Influenza	14/177 (7.9%)	17
Nasopharyngitis	23/177 (13%)	32
Sinusitis	12/177 (6.8%)	14
Upper Respiratory Tract Infection	33/177 (18.6%)	61
Urinary Tract Infection	84/177 (47.5%)	280
Injury, poisoning and procedural complications
Contusion	20/177 (11.3%)	33
Excoriation	10/177 (5.6%)	13
Fall	75/177 (42.4%)	157
Joint Sprain	10/177 (5.6%)	10
Procedural Pain	11/177 (6.2%)	15
Skin Laceration	15/177 (8.5%)	18
Investigations
Blood Cholesterol Increased	13/177 (7.3%)	15
Blood Creatine Phosphokinase Increased	11/177 (6.2%)	14
Blood Triglycerides Increased	9/177 (5.1%)	9
Musculoskeletal and connective tissue disorders
Arthralgia	34/177 (19.2%)	49
Back Pain	30/177 (16.9%)	48
Joint Swelling	11/177 (6.2%)	15
Mobility Decreased	26/177 (14.7%)	32
Muscle Spasms	31/177 (17.5%)	40
Muscular Weakness	45/177 (25.4%)	79
Musculoskeletal Stiffness	16/177 (9%)	19
Myalgia	13/177 (7.3%)	15
Neck Pain	10/177 (5.6%)	11
Osteoporosis	10/177 (5.6%)	10
Pain in Extremity	24/177 (13.6%)	37
Shoulder Pain	11/177 (6.2%)	12
Nervous system disorders
Balance Disorder	17/177 (9.6%)	24
Dizziness	29/177 (16.4%)	40
Headache	40/177 (22.6%)	58
Hypoaesthesia	15/177 (8.5%)	19
Multiple Sclerosis	20/177 (11.3%)	23
Multiple Sclerosis Relapse	43/177 (24.3%)	68
Muscle Spasticity	41/177 (23.2%)	47
Paraesthesia	23/177 (13%)	31
Tremor	15/177 (8.5%)	17
Psychiatric disorders
Anxiety	13/177 (7.3%)	13
Depression	28/177 (15.8%)	29
Insomnia	52/177 (29.4%)	64
Nervousness	9/177 (5.1%)	10
Renal and urinary disorders
Micturition Urgency	14/177 (7.9%)	14
Urinary Incontinence	10/177 (5.6%)	10
Urinary Retention	9/177 (5.1%)	9
Respiratory, thoracic and mediastinal disorders
Dyspnoea	14/177 (7.9%)	18
Skin and subcutaneous tissue disorders
Erythema	9/177 (5.1%)	10
Pruritus	9/177 (5.1%)	11
Rash	18/177 (10.2%)	21
Vascular disorders
Hypertension	20/177 (11.3%)	21

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.