Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01468350
First received: November 7, 2011
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: March 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Cerebral Palsy (CP)
Interventions: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Part A, 11 subjects enrolled and randomized. 6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) and 5 randomized into Sequence AB (dalfampridine-ER – placebo). Part B, 24 subjects enrolled and randomized. 12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) and 12 into Sequence AB (dalfampridine-ER – placebo).

Reporting Groups
  Description
(PART A) Placebo Then Dalfampridine-ER 10mg

Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart

Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg

(PART A) Dalfampridine-ER 10mg Then Placebo

Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart

Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo

(PART B) Placebo Then Dalfampridine-ER 10mg

Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg

Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day

(PART B) Dalfampridine-ER 10mg Then Placebo

Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo

Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day


Participant Flow for 2 periods

Period 1:   (PART A) Day 1, Day 3
    (PART A) Placebo Then Dalfampridine-ER 10mg     (PART A) Dalfampridine-ER 10mg Then Placebo     (PART B) Placebo Then Dalfampridine-ER 10mg     (PART B) Dalfampridine-ER 10mg Then Placebo  
STARTED     6     5     0     0  
COMPLETED     6     5     0     0  
NOT COMPLETED     0     0     0     0  

Period 2:   (PART B) Day 1, Day 15
    (PART A) Placebo Then Dalfampridine-ER 10mg     (PART A) Dalfampridine-ER 10mg Then Placebo     (PART B) Placebo Then Dalfampridine-ER 10mg     (PART B) Dalfampridine-ER 10mg Then Placebo  
STARTED     0     0     12     12  
COMPLETED     0     0     12     12  
NOT COMPLETED     0     0     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 (Took at least one dose)

Reporting Groups
  Description
(PART A) Placebo Then Dalfampridine-ER 10mg

Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart

Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg

(PART A) Dalfampridine-ER 10mg Then Placebo

Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart

Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo

(PART B) Placebo Then Dalfampridine-ER 10mg

Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg

Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day

(PART B) Dalfampridine-ER 10mg Then Placebo

Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo

Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day

Total Total of all reporting groups

Baseline Measures
    (PART A) Placebo Then Dalfampridine-ER 10mg     (PART A) Dalfampridine-ER 10mg Then Placebo     (PART B) Placebo Then Dalfampridine-ER 10mg     (PART B) Dalfampridine-ER 10mg Then Placebo     Total  
Number of Participants  
[units: participants]
  6     5     12     12     35  
Age  
[units: years]
Mean ± Standard Deviation
  33.8  ± 14.29     37.2  ± 9.39     41.1  ± 14.25     36.1  ± 14.04     37.05  ± 12.99  
Gender  
[units: participants]
         
Female     4     4     6     7     21  
Male     2     1     6     5     14  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     2     1     0     1     4  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     1     0     1     1     3  
White     3     4     11     10     28  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  



  Outcome Measures

1.  Primary:   Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)   [ Time Frame: up to 31 days ]

2.  Secondary:   Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function   [ Time Frame: up to 31 days ]
Results not yet posted.   Anticipated Posting 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
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: Vice President - Clinical Development & Medical Affairs
Organization: Acorda Therapeutics, Inc.
phone: 914-347-4300
e-mail: hhenney@acorda.com


No publications provided


Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01468350     History of Changes
Other Study ID Numbers: DALF-CP-1002
Study First Received: November 7, 2011
Results First Received: March 24, 2014
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration