Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01683838|
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : February 5, 2014
Last Update Posted : August 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury Muscle Spasticity||Drug: Fampridine-SR Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||November 2003|
|Actual Study Completion Date :||February 2004|
|Active Comparator: fampridine-SR 50mg/day||
25mg bid (twice daily)
|Placebo Comparator: Placebo||
- Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity [ Time Frame: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98 ]
The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:
1=no increased tone; 2=slight increase in tone, giving a "catch" when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.
The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.
- Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores [ Time Frame: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98 ]
The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.
The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.
- Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores [ Time Frame: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98 ]
The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.
The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.
On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores.
- Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores [ Time Frame: Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98) ]The supervising clinician rated the patient's neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician's overall impression of the patient's neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.
- Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score [ Time Frame: Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98 ]Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.
- Change From Baseline in Mean International Index of Erectile Function (IIEF) Score [ Time Frame: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98 ]
Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.
Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement.
- Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores [ Time Frame: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98 ]
The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).
A positive change signifies improvement.
- Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores [ Time Frame: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98 ]
Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.
A negative change in patient bladder/bowel function diary score signifies improvement.
- Adjusted Mean Change in Subject Bowel Function Diary Scores [ Time Frame: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98 ]
Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.
A negative change in patient bowel function diary score signifies improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683838
Hide Study Locations
|United States, Alabama|
|UAB School of Medicine, 190 Spain Rehab Center|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|Long Beach VA Medical Center|
|Long Beach, California, United States, 90822|
|University of California, Davis|
|Sacramento, California, United States, 95817|
|Santa Clara Valley Medical Center|
|San Jose, California, United States, 95128|
|United States, Colorado|
|Englewood, Colorado, United States, 80110|
|United States, Connecticut|
|Hospital for Special Care|
|New Britain, Connecticut, United States, 06503|
|United States, Illinois|
|Hines VA Hospital|
|Hines, Illinois, United States, 60141|
|United States, Massachusetts|
|Boston University Medical Center|
|Boston, Massachusetts, United States, 02118|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Rehabilitation Institute of Michigan|
|Detroit, Michigan, United States, 48201|
|United States, Minnesota|
|Minneapolis VA Hospital|
|Minneapolis, Minnesota, United States, 55417|
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65212|
|St. Louis University|
|Saint Louis, Missouri, United States, 63104|
|United States, New York|
|University of Rochester/Strong Memorial Hospital|
|Rochester, New York, United States, 14642|
|SUNY Upstate Clinical Trials Office|
|Syracuse, New York, United States, 13045|
|Helen Hayes Hospital|
|West Haverstraw, New York, United States, 13045|
|United States, North Carolina|
|Charlotte Institute of Rehabilitation|
|Charlotte, North Carolina, United States, 28203|
|Wilmington, North Carolina, United States, 28402|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Miami Valley Hospital- Rehabilitation Institute of Medicine|
|Dayton, Ohio, United States, 45409|
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|VA North Texas Health Care System|
|Dallas, Texas, United States, 75216|
|Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390|
|United States, Virginia|
|INOVA Institute of Research and Education|
|Falls Church, Virginia, United States, 22042|
|Medical College of Virginia/VCU|
|Richmond, Virginia, United States, 23298|
|United States, Washington|
|University of Washington Medical Center, Dept. of Rehabilitation|
|Seattle, Washington, United States, 98195|
|United States, Wisconsin|
|Wood VA Medical Center|
|Milwaukee, Wisconsin, United States, 53295|
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1M4|
|Hamilton, Ontario, Canada, L8N 3Z5|
|St. Mary's of the Lake Hospital|
|Kingston, Ontario, Canada, K7L 5A2|
|Study Director:||Andrew Blight, MD||Acorda Therapeutics|