Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury - Tabular View

Tracking Information
First Received Date ^ICMJE	July 12, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	June 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00041717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
Official Title ^ICMJE	Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Spinal Cord Injury Muscle Spasticity
Intervention ^ICMJE	Drug: Fampridine-SR
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	360
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months) Moderate to severe lower-limb spasticity Able to give informed consent and willing to comply with protocol Exclusion Criteria: Pregnancy History of seizures Existing or history of frequent Urinary Tract Infections History of drug or alcohol abuse Allergy to pyridine-containing substances Received a botox injection 4 months prior to study Received an investigational drug within 30 days Previously treated with 4-aminopyridine (4-AP) Not on stable medication dosing in 3 weeks prior to study Abnormal ECG or laboratory value at screening
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00041717
Responsible Party
Study ID Numbers ^ICMJE	SCI-F301/302
Study Sponsor ^ICMJE	Acorda Therapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Acorda Therapeutics
Verification Date	April 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP