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Trial record 17 of 25 for:    Spinal Cord Injuries | ( Map: Minnesota, United States )

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

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ClinicalTrials.gov Identifier: NCT00041717
Recruitment Status : Completed
First Posted : July 16, 2002
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Spinal Cord Injury
Muscle Spasticity
Interventions Drug: Fampridine-SR
Other: Placebo
Enrollment 213
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description Fampridine-sustained release (SR) : 25mg bid (twice daily) Placebo : Placebo
Period Title: Overall Study
Started 114 98
Completed 81 86
Not Completed 33 12
Arm/Group Title Fampridine-SR 50mg/Day Placebo Total
Hide Arm/Group Description Fampridine-SR : 25mg bid (twice daily) Placebo : Placebo Total of all reporting groups
Overall Number of Baseline Participants 114 98 212
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 98 participants 212 participants
41.6  (12.05) 40.1  (13.10) 40.9  (12.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 98 participants 212 participants
Female
14
  12.3%
13
  13.3%
27
  12.7%
Male
100
  87.7%
85
  86.7%
185
  87.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 98 participants 212 participants
American Indian or Alaska Native
1
   0.9%
1
   1.0%
2
   0.9%
Asian
0
   0.0%
2
   2.0%
2
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  15.8%
12
  12.2%
30
  14.2%
White
94
  82.5%
81
  82.7%
175
  82.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.9%
2
   2.0%
3
   1.4%
1.Primary Outcome
Title Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
Hide Description 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.
Time Frame Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 109 96
Mean (Standard Error)
Unit of Measure: units on a scale
-0.19  (0.039) -0.15  (0.042)
2.Primary Outcome
Title Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
Hide Description 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.
Time Frame Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 109 96
Mean (Standard Error)
Unit of Measure: units on a scale
-0.2  (0.08) -0.1  (0.09)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description Fampridine-SR : 25mg bid (twice daily) Placebo : Placebo
All-Cause Mortality
Fampridine-SR 50mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fampridine-SR 50mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/114 (5.26%)      6/98 (6.12%)    
Gastrointestinal disorders     
Gastrointestinal disorder  0/114 (0.00%)  0 1/98 (1.02%)  1
General disorders     
Reaction unevaluable  0/114 (0.00%)  0 1/98 (1.02%)  1
Infections and infestations     
Cellulitis  1/114 (0.88%)  1 0/98 (0.00%)  0
Infection  0/114 (0.00%)  0 1/98 (1.02%)  1
Osteomyelitis  0/114 (0.00%)  0 1/98 (1.02%)  1
Pneumonia  1/114 (0.88%)  1 0/98 (0.00%)  0
Pyelonephritis  0/114 (0.00%)  0 1/98 (1.02%)  1
Urinary incontinence  1/114 (0.88%)  1 0/98 (0.00%)  0
Urinary tract infection  0/114 (0.00%)  0 1/98 (1.02%)  1
Nervous system disorders     
Syncope  0/114 (0.00%)  0 1/98 (1.02%)  1
Aphasia  1/114 (0.88%)  1 0/98 (0.00%)  0
Hypokinesia  1/114 (0.88%)  1 0/98 (0.00%)  0
Insomnia  1/114 (0.88%)  1 0/98 (0.00%)  0
Psychiatric disorders     
Anxiety  1/114 (0.88%)  1 0/98 (0.00%)  0
Hallucinations  1/114 (0.88%)  1 0/98 (0.00%)  0
Hypertonia  0/114 (0.00%)  0 1/98 (1.02%)  1
Hyperesthesia  1/114 (0.88%)  2 0/98 (0.00%)  0
Nervousness  1/114 (0.88%)  1 0/98 (0.00%)  0
1
Term from vocabulary, COSTART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Fampridine-SR 50mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   94/114 (82.46%)      84/98 (85.71%)    
Blood and lymphatic system disorders     
Leukocytosis  3/114 (2.63%)  3 2/98 (2.04%)  3
Eye disorders     
Amblyopia  3/114 (2.63%)  3 0/98 (0.00%)  0
Gastrointestinal disorders     
Constipation  11/114 (9.65%)  18 8/98 (8.16%)  9
Dyspepsia  8/114 (7.02%)  12 2/98 (2.04%)  2
Nausea  10/114 (8.77%)  12 4/98 (4.08%)  5
Diarrhea  8/114 (7.02%)  9 8/98 (8.16%)  8
Abdominal pain  5/114 (4.39%)  5 4/98 (4.08%)  4
Gastroenteritis  4/114 (3.51%)  4 0/98 (0.00%)  0
Vomiting  3/114 (2.63%)  4 2/98 (2.04%)  2
Fecal incontinence  3/114 (2.63%)  3 1/98 (1.02%)  1
Flatulence  2/114 (1.75%)  2 2/98 (2.04%)  4
Gastrointestinal disorder  1/114 (0.88%)  1 3/98 (3.06%)  5
Nausea and vomiting  1/114 (0.88%)  1 2/98 (2.04%)  2
General disorders     
Pain  13/114 (11.40%)  18 14/98 (14.29%)  18
Chills  4/114 (3.51%)  6 1/98 (1.02%)  1
Fever  5/114 (4.39%)  5 2/98 (2.04%)  2
Abnormal gait  3/114 (2.63%)  3 1/98 (1.02%)  1
Peripheral edema  3/114 (2.63%)  3 2/98 (2.04%)  3
Chest pain  1/114 (0.88%)  1 2/98 (2.04%)  2
Infections and infestations     
Urinary tract infection  34/114 (29.82%)  42 16/98 (16.33%)  20
Infection  9/114 (7.89%)  11 10/98 (10.20%)  12
Flu syndrome  4/114 (3.51%)  4 4/98 (4.08%)  4
Rhinitis  1/114 (0.88%)  1 6/98 (6.12%)  6
Injury, poisoning and procedural complications     
Accidental injury  10/114 (8.77%)  17 17/98 (17.35%)  19
Metabolism and nutrition disorders     
Anorexia  5/114 (4.39%)  5 1/98 (1.02%)  1
Hypokalemia  0/114 (0.00%)  0 2/98 (2.04%)  2
Musculoskeletal and connective tissue disorders     
Asthenia  9/114 (7.89%)  11 4/98 (4.08%)  5
Back pain  9/114 (7.89%)  11 6/98 (6.12%)  6
Arthralgia  7/114 (6.14%)  7 10/98 (10.20%)  12
Leg cramps  1/114 (0.88%)  1 3/98 (3.06%)  3
Neck pain  1/114 (0.88%)  1 2/98 (2.04%)  2
Joint disorder  0/114 (0.00%)  0 2/98 (2.04%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cyst  0/114 (0.00%)  0 2/98 (2.04%)  2
Nervous system disorders     
Hypertonia  23/114 (20.18%)  31 25/98 (25.51%)  35
Headache  10/114 (8.77%)  15 8/98 (8.16%)  13
Paresthesia  10/114 (8.77%)  11 5/98 (5.10%)  5
Hypotonia  4/114 (3.51%)  5 1/98 (1.02%)  1
Hyperesthesia  2/114 (1.75%)  3 2/98 (2.04%)  2
Psychiatric disorders     
Insomnia  10/114 (8.77%)  10 3/98 (3.06%)  3
Nervousness  8/114 (7.02%)  8 0/98 (0.00%)  0
Anxiety  6/114 (5.26%)  6 1/98 (1.02%)  1
Depression  5/114 (4.39%)  5 4/98 (4.08%)  4
Confusion  3/114 (2.63%)  4 0/98 (0.00%)  0
Abnormal dreams  3/114 (2.63%)  3 2/98 (2.04%)  2
Renal and urinary disorders     
Pelvic pain  5/114 (4.39%)  7 0/98 (0.00%)  0
Urine abnormality  3/114 (2.63%)  7 0/98 (0.00%)  0
Urinary incontinence  6/114 (5.26%)  6 5/98 (5.10%)  6
Hematuria  3/114 (2.63%)  3 2/98 (2.04%)  3
Urinary frequency  3/114 (2.63%)  3 1/98 (1.02%)  1
Urinary retention  3/114 (2.63%)  3 1/98 (1.02%)  1
Urinary urgency  3/114 (2.63%)  3 1/98 (1.02%)  1
Reproductive system and breast disorders     
Epididymitis  0/114 (0.00%)  0 2/98 (2.04%)  2
Skin and subcutaneous tissue disorders     
Sweating  7/114 (6.14%)  11 1/98 (1.02%)  1
Skin ulcer  7/114 (6.14%)  10 7/98 (7.14%)  9
Rash  7/114 (6.14%)  8 3/98 (3.06%)  3
Nail disorder  4/114 (3.51%)  4 2/98 (2.04%)  2
Vesiculobullous rash  1/114 (0.88%)  1 3/98 (3.06%)  4
Urticaria  0/114 (0.00%)  0 2/98 (2.04%)  2
Vascular disorders     
Dizziness  15/114 (13.16%)  18 3/98 (3.06%)  4
1
Term from vocabulary, COSTART
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Andrew Blight, Ph.D. Chief Scientific Officer
Organization: Acorda Therapeutics, Inc.
Phone: 914-347-4300 ext 5102
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00041717     History of Changes
Other Study ID Numbers: SCI-F301
First Submitted: July 12, 2002
First Posted: July 16, 2002
Results First Submitted: February 26, 2013
Results First Posted: May 31, 2013
Last Update Posted: May 31, 2013