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


  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