Back to resultsDalfampridine and Gait in Spinocerebellar Ataxias
Primary Purpose
Spinocerebellar Ataxias Type 1, Spinocerebellar Ataxias Type 2, Spinocerebellar Ataxias Type 3
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dalfampridine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinocerebellar Ataxias Type 1
Eligibility Criteria
Inclusion Criteria:
- Individuals at age 18 years or older.
- Individuals who can provide the informed consent
- Genetic confirmed definite spinocerebellar ataxias (SCA)
- Able to complete two trials of the timed 25-foot walk at screening
Exclusion Criteria:
- Patients who has severe ataxia and unable to ambulate.
- Any orthopedic condition that would affect motor performance.
- Patients with secondary ataxia from general medical disorders
- Individuals who have major psychiatric disorders that prevents compliance
- History of epilepsy
- Patients with active drug or alcohol use or dependence that would interfere with adherence to study requirements
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dalfampridine and then placebo
Placebo, Then Dalfampridine
Arm Description
Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period.
Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.
Outcomes
Primary Outcome Measures
Change in Timed 25 Feet Walking Test (T25FW)
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time, in seconds, is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.
Secondary Outcome Measures
Change in Scale of Assessment and Rating of Ataxia (SARA)
Scale for the assessment and rating of ataxia (SARA) is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level. SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. SARA score ranges from 0 to 40, with higher scores indicating more severe disease.
Biomechanical Assessment of Gait (BAG)-Stride Length
Biomechanical Assessment of Gait is a sensitive, quantitative movement analysis system. Stride length was analyzed. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.
Full Information
NCT ID
NCT01811706
First Posted
March 6, 2013
Last Updated
January 8, 2015
Sponsor
University of Florida
Collaborators
Acorda Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT01811706
Brief Title
Dalfampridine and Gait in Spinocerebellar Ataxias
Official Title
Therapeutic Effect of Dalfampridine on Gait Incoordination in Spinocerebellar Ataxias- A Randomized, Double-blinded, Placebo-controlled, Crossover Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Acorda Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions for patients with spinocerebellar ataxia.
Detailed Description
Twenty spinocerebellar ataxia patients will be randomized to receive either Dalfampridine or placebo over a total period of 10 weeks. After entering the study, patients will return every 2 weeks for evaluation. After four weeks, intervention will be stopped and patient will enter a 2-week wash out period where they do not take any drug. Then, patients will be given the opposite treatment (Dalfampridine or placebo) and this "crossover" study will be performed for another 4 weeks. Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinocerebellar Ataxias Type 1, Spinocerebellar Ataxias Type 2, Spinocerebellar Ataxias Type 3, Spinocerebellar Ataxias Type 6
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dalfampridine and then placebo
Arm Type
Experimental
Arm Description
Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period.
Arm Title
Placebo, Then Dalfampridine
Arm Type
Experimental
Arm Description
Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Dalfampridine
Other Intervention Name(s)
Ampyra
Intervention Description
Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Placebo will be administered orally every 12 hours, for a 4 week period.
Primary Outcome Measure Information:
Title
Change in Timed 25 Feet Walking Test (T25FW)
Description
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time, in seconds, is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.
Time Frame
Baseline and 4 weeks after Dalfampridine or placebo
Secondary Outcome Measure Information:
Title
Change in Scale of Assessment and Rating of Ataxia (SARA)
Description
Scale for the assessment and rating of ataxia (SARA) is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level. SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. SARA score ranges from 0 to 40, with higher scores indicating more severe disease.
Time Frame
Baseline and 4 weeks after Dalfampridine or placebo
Title
Biomechanical Assessment of Gait (BAG)-Stride Length
Description
Biomechanical Assessment of Gait is a sensitive, quantitative movement analysis system. Stride length was analyzed. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.
Time Frame
Baseline and 4 weeks after Dalfampridine or placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals at age 18 years or older.
Individuals who can provide the informed consent
Genetic confirmed definite spinocerebellar ataxias (SCA)
Able to complete two trials of the timed 25-foot walk at screening
Exclusion Criteria:
Patients who has severe ataxia and unable to ambulate.
Any orthopedic condition that would affect motor performance.
Patients with secondary ataxia from general medical disorders
Individuals who have major psychiatric disorders that prevents compliance
History of epilepsy
Patients with active drug or alcohol use or dependence that would interfere with adherence to study requirements
Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangbin Xia, MD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dalfampridine and Gait in Spinocerebellar Ataxias
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