A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01605825
First received: May 21, 2012
Last updated: March 12, 2014
Last verified: March 2014
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Interventions: Drug: placebo/dalfampridine-ER
Drug: dalfampridine-ER/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
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
Placebo/Dalfampridine-ER

Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:

Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.

10mg tablets, will be taken orally, twice daily approximately 12 hours apart

Dalfampridine-ER/Placebo

Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:

Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.

10mg tablets, will be taken orally, twice daily approximately 12 hours apart


Participant Flow:   Overall Study
    Placebo/Dalfampridine-ER     Dalfampridine-ER/Placebo  
STARTED     55     28  
COMPLETED     45     25  
NOT COMPLETED     10     3  
Adverse Event                 4                 2  
Withdrawal by Subject                 0                 1  
Non-Compliance -Investigational Drug                 3                 0  
Non-Compliance with Protocol                 3                 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: The Safety Population consists of all randomized subjects who took at least one dose of investigational product.

Reporting Groups
  Description
Placebo/Dalfampridine-ER

Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:

Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.

10mg tablets, will be taken orally, twice daily approximately 12 hours apart

Dalfampridine-ER/Placebo

Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:

Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.

10mg tablets, will be taken orally, twice daily approximately 12 hours apart

Total Total of all reporting groups

Baseline Measures
    Placebo/Dalfampridine-ER     Dalfampridine-ER/Placebo     Total  
Number of Participants  
[units: participants]
  55     28     83  
Age  
[units: years]
Mean ± Standard Deviation
  57.5  ± 9.72     63.5  ± 8.91     59.5  ± 9.82  
Gender  
[units: participants]
     
Female     18     10     28  
Male     37     18     55  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     15     4     19  
White     38     22     60  
More than one race     0     0     0  
Unknown or Not Reported     0     2     2  



  Outcome Measures

1.  Primary:   Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: up to 36 days ]

2.  Other Pre-specified:   Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)   [ Time Frame: Screening visit, Days 1, 8, 15, 22, 29 and 36 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Other Pre-specified:   Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)   [ Time Frame: Screening visit, Days 1, 8, 15, 22, 29, and 36 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Other Pre-specified:   Manual Dexterity as Measured by the Box and Block Test   [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Other Pre-specified:   Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale   [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Other Pre-specified:   Subject Global Impression (SGI) Scale   [ Time Frame: Days 8, 15, 22, 29 and 36 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Other Pre-specified:   Clinician Global Impression (CGI) Scale   [ Time Frame: Days 8, 15, 22, 29 and 36 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Other Pre-specified:   Hand Strength as Measured by the Grip Test and Pinch Tests   [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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Time Frame up to 36 days
Additional Description All adverse events discussed in this report are treatment-emergent adverse events (TEAEs) unless otherwise indicated. Therefore, events that had a date of onset, or worsening, on or after start of double-blind treatment through 7 days after the last dose of double-blind treatment

Reporting Groups
  Description
Placebo No text entered.
Dalfampridine-ER No text entered.

Serious Adverse Events
    Placebo     Dalfampridine-ER  
Total, serious adverse events      
# participants affected / at risk     2/81 (2.47%)     2/77 (2.60%)  
Blood and lymphatic system disorders      
Microcytic anaemia 1    
# participants affected / at risk     0/81 (0.00%)     1/77 (1.30%)  
Gastrointestinal disorders      
Nausea 1    
# participants affected / at risk     1/81 (1.23%)     0/77 (0.00%)  
Vomiting 1    
# participants affected / at risk     1/81 (1.23%)     0/77 (0.00%)  
Injury, poisoning and procedural complications      
Intentional overdose 1    
# participants affected / at risk     0/81 (0.00%)     1/77 (1.30%)  
Metabolism and nutrition disorders      
Dehydration 1    
# participants affected / at risk     1/81 (1.23%)     0/77 (0.00%)  
Nervous system disorders      
Convulsion 1    
# participants affected / at risk     1/81 (1.23%)     2/77 (2.60%)  
Psychiatric disorders      
Suicide attempt 1    
# participants affected / at risk     0/81 (0.00%)     1/77 (1.30%)  
1 Term from vocabulary, MedDRA (15.0)




  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
No text entered.


  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: Study Director
Organization: Acorda Therapeutics, Inc.
phone: 914-347-4300


No publications provided by Acorda Therapeutics

Publications automatically indexed to this study:

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01605825     History of Changes
Other Study ID Numbers: DALF-PS-1003
Study First Received: May 21, 2012
Results First Received: January 28, 2014
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration