Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01328379
First received: March 29, 2011
Last updated: September 3, 2013
Last verified: September 2013
Results First Received: April 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Interventions: Drug: Dalfampridine-ER 5mg
Drug: Dalfampridine-ER 10mg
Other: 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
Patients were to be enrolled at a minimum of 60 investigational centers in the United States until a minimum of 405 patients had been randomized.

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
Placebo placebo, twice daily
Dalfampridine-ER 5mg

5mg, twice daily

Dalfampridine-ER 5mg: 5mg, twice daily

Dalfampridine-ER 10mg

10mg, twice daily

Dalfampridine-ER 10mg: 10mg, twice daily


Participant Flow:   Overall Study
    Placebo     Dalfampridine-ER 5mg     Dalfampridine-ER 10mg  
STARTED     143     144     143  
COMPLETED     142     144     143  
NOT COMPLETED     1     0     0  



  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.
Safety Population: All randomized patients who took at least one dose of study medication.

Reporting Groups
  Description
Placebo placebo, twice daily
Dalfampridine-ER 5mg

5mg, twice daily

Dalfampridine-ER 5mg: 5mg, twice daily

Dalfampridine-ER 10mg

10mg, twice daily

Dalfampridine-ER 10mg: 10mg, twice daily

Total Total of all reporting groups

Baseline Measures
    Placebo     Dalfampridine-ER 5mg     Dalfampridine-ER 10mg     Total  
Number of Participants  
[units: participants]
  142     144     143     429  
Age  
[units: years]
Mean ± Standard Deviation
  52.2  ± 0.83     52.2  ± 0.77     53.4  ± 0.79     52.6  ± 0.46  
Gender  
[units: participants]
       
Female     100     102     98     300  
Male     42     42     45     129  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     10     7     3     20  
Not Hispanic or Latino     132     137     140     409  
Unknown or Not Reported     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).   [ Time Frame: Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4) ]

2.  Secondary:   Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).   [ Time Frame: Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4) ]

3.  Secondary:   Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3   [ Time Frame: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4) ]

4.  Secondary:   Change From Baseline in MSWS-12 at Visit 2   [ Time Frame: Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period ) ]

5.  Secondary:   Change From Baseline in Six-Minute Walk Distance at Visit 2   [ Time Frame: Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period ) ]

6.  Secondary:   Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3.   [ Time Frame: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4) ]

7.  Secondary:   Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3.   [ Time Frame: Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Vice President - Clinical Development & Medical Affairs
Organization: Acorda Therapeutics
phone: (914) 347- 4300 ext 5138
e-mail: hhenney@acorda.com


No publications provided


Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01328379     History of Changes
Other Study ID Numbers: DER-401
Study First Received: March 29, 2011
Results First Received: April 16, 2013
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration