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Dalfampridine and Gait in Spinocerebellar Ataxias

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ClinicalTrials.gov Identifier: NCT01811706
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : January 12, 2015
Last Update Posted : January 12, 2015
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinocerebellar Ataxias Type 1 Spinocerebellar Ataxias Type 2 Spinocerebellar Ataxias Type 3 Spinocerebellar Ataxias Type 6 Drug: Dalfampridine Drug: Placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Dalfampridine on Gait Incoordination in Spinocerebellar Ataxias- A Randomized, Double-blinded, Placebo-controlled, Crossover Clinical Trial
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dalfampridine and then placebo
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.
 Drug: Dalfampridine
Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period
Other Name: Ampyra

Drug: Placebo
Placebo will be administered orally every 12 hours, for a 4 week period.
Other Name: Sugar Pill
Experimental: Placebo, Then Dalfampridine
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.
 Drug: Dalfampridine
Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period
Other Name: Ampyra

Drug: Placebo
Placebo will be administered orally every 12 hours, for a 4 week period.
Other Name: Sugar Pill


Outcome Measures
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Primary Outcome Measures :
  1. Change in Timed 25 Feet Walking Test (T25FW) [ Time Frame: Baseline and 4 weeks after Dalfampridine or placebo ]
    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 :
  1. Change in Scale of Assessment and Rating of Ataxia (SARA) [ Time Frame: Baseline and 4 weeks after Dalfampridine or placebo ]
    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.

  2. Biomechanical Assessment of Gait (BAG)-Stride Length [ Time Frame: Baseline and 4 weeks after Dalfampridine or placebo ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811706


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Acorda Therapeutics
Investigators
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Principal Investigator: Guangbin Xia, MD, PhD University of Florida
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01811706    
Other Study ID Numbers: 20121107
1133511 ( Other Identifier: WIRB Study Number )
First Posted: March 14, 2013    Key Record Dates
Results First Posted: January 12, 2015
Last Update Posted: January 12, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Machado-Joseph Disease
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Cerebellar Diseases
Brain Diseases
 Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action