Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT00648908
First received: March 28, 2008
Last updated: February 24, 2012
Last verified: January 2012
Results First Received: January 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Intervention: Drug: Fampridine-SR

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fampridine-SR Tablets, 10mg twice daily

Participant Flow:   Overall Study
    Fampridine-SR  
STARTED     269  
COMPLETED     154  
NOT COMPLETED     115  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Fampridine-SR Tablets, 10mg twice daily

Baseline Measures
    Fampridine-SR  
Number of Participants  
[units: participants]
  269  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     256  
>=65 years     13  
Age  
[units: Years]
Mean ± Standard Deviation
 
Age (years)     52.1  ± 8.75  
Gender  
[units: Participants]
 
Female     182  
Male     87  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     3  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     11  
White     251  
More than one race     3  
Unknown or Not Reported     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Summary of Treatment Emergent Adverse Events (TEAE).   [ Time Frame: up to 5 years ]

2.  Secondary:   Timed 25 Foot Walk (T25FW)   [ Time Frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit ]

3.  Secondary:   Subject Global Impression (SGI)   [ Time Frame: visit 1 and every clinic visit ]

4.  Secondary:   Clinician Global Impression of Change (CGIC)   [ Time Frame: visit 1 and every clinic visit ]

5.  Secondary:   Expanded Disability Status Scale (EDSS)   [ Time Frame: Screening visit, visit 6 and every 24 months thereafter ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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: Andrew Blight, PhD Chief Scientific Officer
Organization: Acorda Therapeutics, Inc.
phone: 914-347-4300 ext 4102
e-mail: ablight@acorda.com


No publications provided


Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00648908     History of Changes
Other Study ID Numbers: MS-F203EXT
Study First Received: March 28, 2008
Results First Received: January 25, 2012
Last Updated: February 24, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada