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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01683838
First received: August 24, 2012
Last updated: January 6, 2014
Last verified: January 2014
Results First Received: July 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Spinal Cord Injury
Muscle Spasticity
Interventions: Drug: Fampridine-SR
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The randomization schedule was created prior to the start of the study, and was blocked and stratified by site and by concomitant anti-spasmodic medication status to ensure treatment balance between patients who were treated with anti-spasmodic medications upon entry into the study and those who were not.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Investigational drug assignments were communicated through an Interactive Voice Response System (IVRS).

Reporting Groups
  Description
Fampridine-SR 50mg/Day Fampridine-SR : 25mg bid (twice daily)
Placebo Placebo : Placebo

Participant Flow:   Overall Study
    Fampridine-SR 50mg/Day     Placebo  
STARTED     104     100  
Intent to Treat (ITT) Population     103     100  
Safety Population     103     100  
Efficacy Population     89     93  
COMPLETED     78     88  
NOT COMPLETED     26     12  
Adverse Event                 12                 2  
Protocol Violation                 3                 1  
Withdrawal by Subject                 6                 5  
Lost to Follow-up                 1                 1  
not specified                 4                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

104 patients randomized to Fampridine-SR 50mg/day 100 patients randomized to Placebo. Total patients randomized = 204.

Overall, 203 (99.5%) patients were included in the ITT population, 182 (89.2%) in the Efficacy population and 203 (99.5%) in the Safety population.


Reporting Groups
  Description
Fampridine-SR 50mg/Day Fampridine-SR : 25mg bid (twice daily)
Placebo Placebo : Placebo
Total Total of all reporting groups

Baseline Measures
    Fampridine-SR 50mg/Day     Placebo     Total  
Number of Participants  
[units: participants]
  103     100     203  
Age  
[units: Years]
Mean ± Standard Deviation
  41.3  ± 11.79     40.5  ± 12.25     40.9  ± 12.00  
Gender  
[units: participants]
     
Female     17     14     31  
Male     86     86     172  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     92     87     179  
Black or African American     8     10     18  
Asian/Pacific Islander     1     0     1  
Other     2     3     5  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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) ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Chief Scientific Officer
Organization: Acorda Therapeutics, Inc.
phone: 914-347-4300 ext 5102
e-mail: ablight@acorda.com


No publications provided


Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01683838     History of Changes
Other Study ID Numbers: SCI-F302
Study First Received: August 24, 2012
Results First Received: July 23, 2013
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration