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Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fampridine-SR 50mg/day | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine-SR | Drug | 25mg bid (twice daily) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity | The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement. | Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 |
| Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment | This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome. | Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Blight | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeshore Rehabilitation Hospital | Birmingham | Alabama | 35209 | United States | ||
| Barrow Neurological Institute |
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| Label | URL |
|---|---|
| Related Info | View source |
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One patient did not take any investigational drug and was excluded from the safety and ITT populations. The remaining 212 patients were included in the ITT and safety populations: 98 in the placebo and 114 in the Fampridine-SR 25 mg b.i.d. group.
The target population consists of patients with chronic incomplete spinal cord injury (SCI) whose injury occurred at least 18 months prior to screening, and whose neurological status has been stable for at least 6 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fampridine-SR 50mg/Day | Fampridine-sustained release (SR) : 25mg bid (twice daily) |
| FG001 | Placebo | Placebo : Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Other |
Placebo |
|
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Baptist Medical Center | Little Rock | Arkansas | 72205 | United States |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
| Neuro-Therapeutics, Inc | Pasadena | California | 91005 | United States |
| Neurology Associates, P.A. | Wilmington | Delaware | 19806 | United States |
| National Rehabilitation Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine | Miami | Florida | 33136 | United States |
| Rehabilitation Hospital | Sunrise | Florida | 33351 | United States |
| Shepherd Spinal Center | Atlanta | Georgia | 30309 | United States |
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
| Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG | Oak Lawn | Illinois | 60453 | United States |
| Springfield Clinic-Neuroscience Institute | Springfield | Illinois | 62702 | United States |
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02114 | United States |
| HEALTHSOUTH Braintree Rehabilitation Hospital | Braintree | Massachusetts | 02185 | United States |
| HEALTHSOUTH New England Rehabilitation Hospital | Woburn | Massachusetts | 01801 | United States |
| Mary Free Bed Hospital & Rehabilitation Center | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine, Div. of Rehab/Neurology | St Louis | Missouri | 63110 | United States |
| Montana Neuroscience | Missoula | Montana | 59802 | United States |
| Kessler Institute of Rehabilitation | West Orange | New Jersey | 07052 | United States |
| The Burke Rehabilitation Hospital | White Plains | New York | 10605 | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Clinical Research Services | Bismarck | North Dakota | 58501 | United States |
| Drake Center | Cincinnati | Ohio | 45216 | United States |
| Cleveland VAMC | Cleveland | Ohio | 44106 | United States |
| Good Shepherd Rehabilitation | Allentown | Pennsylvania | 18103 | United States |
| Bryn Mawr Rehabilitation Hospital | Malvern | Pennsylvania | 19355 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| HEALTHSOUTH Harmarville Rehabilitation Hospital | Pittsburgh | Pennsylvania | 15238 | United States |
| Northeastern Rehabilitation Associates | Scranton | Pennsylvania | 18501 | United States |
| Rehabilitation Services University of Utah Hospitals and Clinics | Salt Lake City | Utah | 84132 | United States |
| Hampton VA Hospital | Hampton | Virginia | 23667 | United States |
| Richmond VA Medical Center (Hunter Holmes McGuire) | Richmond | Virginia | 23249 | United States |
| CAMC Health Education & Research Institute | Charleston | West Virginia | 25304 | United States |
| Foothills Provincial General Hospital | Calgary | Alberta | T2N 2T9 | Canada |
| Glenrose Rehabilitation Hospital | Edmonton | Alberta | T5G 0B7 | Canada |
| G.F. Strong Rehabilitation Centre | Vancouver | British Columbia | V5Z 2G9 | Canada |
| Stan Cassidy Centre for Rehabilitation | Fredericton | New Brunswick | E3B 4R3 | Canada |
| QEII HSC-Nova Scotia Rehabilitation Centre | Halifax | Nova Scotia | B3M 4K4 | Canada |
| Parkwood Hospital Site, St. Joseph's Health Care | London | Ontario | N6C 5J1 | Canada |
| The Rehabilitation Centre | Ottawa | Ontario | K1H 8M2 | Canada |
| Toronto Rehabilitation Institute, Lyndhurst Centre | Toronto | Ontario | M5G 3V9 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fampridine-SR 50mg/Day | Fampridine-SR : 25mg bid (twice daily) |
| BG001 | Placebo | Placebo : Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity | The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement. | Intent to treat (ITT) population | Posted | Mean | Standard Error | units on a scale | Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment | This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome. | ITT | Posted | Mean | Standard Error | units on a scale | Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 |
|
|
Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fampridine-SR 50mg/Day | Fampridine-SR : 25mg bid (twice daily) | 6 | 114 | 94 | 114 | ||
| EG001 | Placebo | Placebo : Placebo | 6 | 98 | 84 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | COSTART |
| ||
| Infection | Infections and infestations | COSTART |
| ||
| Reaction unevaluable | General disorders | COSTART |
| ||
| Syncope | Nervous system disorders | COSTART |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | COSTART |
| ||
| Osteomyelitis | Infections and infestations | COSTART |
| ||
| Anxiety | Psychiatric disorders | COSTART |
| ||
| Aphasia | Nervous system disorders | COSTART |
| ||
| Hallucinations | Psychiatric disorders | COSTART |
| ||
| Hypertonia | Psychiatric disorders | COSTART |
| ||
| Hyperesthesia | Psychiatric disorders | COSTART |
| ||
| Hypokinesia | Nervous system disorders | COSTART |
| ||
| Insomnia | Nervous system disorders | COSTART |
| ||
| Nervousness | Psychiatric disorders | COSTART |
| ||
| Pneumonia | Infections and infestations | COSTART |
| ||
| Pyelonephritis | Infections and infestations | COSTART |
| ||
| Urinary incontinence | Infections and infestations | COSTART |
| ||
| Urinary tract infection | Infections and infestations | COSTART |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | COSTART |
| ||
| Hypertonia | Nervous system disorders | COSTART |
| ||
| Constipation | Gastrointestinal disorders | COSTART |
| ||
| Dizziness | Vascular disorders | COSTART |
| ||
| Pain | General disorders | COSTART |
| ||
| Accidental injury | Injury, poisoning and procedural complications | COSTART |
| ||
| Headache | Nervous system disorders | COSTART |
| ||
| Dyspepsia | Gastrointestinal disorders | COSTART |
| ||
| Nausea | Gastrointestinal disorders | COSTART |
| ||
| Asthenia | Musculoskeletal and connective tissue disorders | COSTART |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | COSTART |
| ||
| Infection | Infections and infestations | COSTART |
| ||
| Paresthesia | Nervous system disorders | COSTART |
| ||
| Sweating | Skin and subcutaneous tissue disorders | COSTART |
| ||
| Insomnia | Psychiatric disorders | COSTART |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | COSTART |
| ||
| Diarrhea | Gastrointestinal disorders | COSTART |
| ||
| Nervousness | Psychiatric disorders | COSTART |
| ||
| Rash | Skin and subcutaneous tissue disorders | COSTART |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART |
| ||
| Pelvic pain | Renal and urinary disorders | COSTART |
| ||
| Urine abnormality | Renal and urinary disorders | COSTART |
| ||
| Anxiety | Psychiatric disorders | COSTART |
| ||
| Chills | General disorders | COSTART |
| ||
| Urinary incontinence | Renal and urinary disorders | COSTART |
| ||
| Abdominal pain | Gastrointestinal disorders | COSTART |
| ||
| Anorexia | Metabolism and nutrition disorders | COSTART |
| ||
| Depression | Psychiatric disorders | COSTART |
| ||
| Fever | General disorders | COSTART |
| ||
| Hypotonia | Nervous system disorders | COSTART |
| ||
| Confusion | Psychiatric disorders | COSTART |
| ||
| Flu syndrome | Infections and infestations | COSTART |
| ||
| Gastroenteritis | Gastrointestinal disorders | COSTART |
| ||
| Nail disorder | Skin and subcutaneous tissue disorders | COSTART |
| ||
| Vomiting | Gastrointestinal disorders | COSTART |
| ||
| Abnormal dreams | Psychiatric disorders | COSTART |
| ||
| Abnormal gait | General disorders | COSTART |
| ||
| Amblyopia | Eye disorders | COSTART |
| ||
| Fecal incontinence | Gastrointestinal disorders | COSTART |
| ||
| Hematuria | Renal and urinary disorders | COSTART |
| ||
| Hyperesthesia | Nervous system disorders | COSTART |
| ||
| Leukocytosis | Blood and lymphatic system disorders | COSTART |
| ||
| Peripheral edema | General disorders | COSTART |
| ||
| Urinary frequency | Renal and urinary disorders | COSTART |
| ||
| Urinary retention | Renal and urinary disorders | COSTART |
| ||
| Urinary urgency | Renal and urinary disorders | COSTART |
| ||
| Flatulence | Gastrointestinal disorders | COSTART |
| ||
| Chest pain | General disorders | COSTART |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | COSTART |
| ||
| Leg cramps | Musculoskeletal and connective tissue disorders | COSTART |
| ||
| Nausea and vomiting | Gastrointestinal disorders | COSTART |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | COSTART |
| ||
| Rhinitis | Infections and infestations | COSTART |
| ||
| Vesiculobullous rash | Skin and subcutaneous tissue disorders | COSTART |
| ||
| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART |
| ||
| Epididymitis | Reproductive system and breast disorders | COSTART |
| ||
| Hypokalemia | Metabolism and nutrition disorders | COSTART |
| ||
| Joint disorder | Musculoskeletal and connective tissue disorders | COSTART |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | COSTART |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Blight, Ph.D. Chief Scientific Officer | Acorda Therapeutics, Inc. | 914-347-4300 | 5102 | ablight@acorda.com |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|