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Trial record 5 of 12 for:    "Spinocerebellar ataxia 2"

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

Tracking Information
First Submitted Date  ICMJE March 6, 2013
First Posted Date  ICMJE March 14, 2013
Results First Submitted Date  ICMJE December 10, 2014
Results First Posted Date  ICMJE January 12, 2015
Last Update Posted Date January 12, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
  • Change in Timed 25 Feet Walking Test (T25FW) [ Time Frame: Screening and week 10 ]
    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 is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. Patients may use walking assistance devices if needed.
  • Change in Biomechanical Assessment of Gait (BAG) [ Time Frame: Screening and week 10 ]
    Biomechanical Assessment of Gait is a sensitive, quantitative movement analysis system. The analysis includes walking velocity, stride length, step width, double support and single support times, and center of mass displacement.
  • Change in Balance Test (BT) [ Time Frame: Screening and week 10 ]
    For 20 seconds, patients will stand on a pad that measures sway and tests balance, once with eyes open and once with eyes closed.
Change History Complete list of historical versions of study NCT01811706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
  • Change in Scale of Assessment and Rating of Ataxia (SARA) [ Time Frame: Screening and week 10 ]
    SARA is a clinical scale including 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.
  • Change in Karnofsky Performance Scale (KPS) [ Time Frame: Screening and week 10 ]
    Karnofsky Performance Scale (KPS) will be used to measure functional status. It was designed to measure the level of patient activity and medical care requirements. It is a general measure of patient independence.
  • Change in World Health Organization Quality of Life (WHOQOL) Questionnaire [ Time Frame: Screening and week 10 ]
    The WHOQOL questionnaire is an international cross-culturally comparable quality of life assessment instrument. It assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 13, 2013)
  • Dalfampridine plasma level [ Time Frame: week 4 and week 10 ]
    This is a blood test to monitor compliance by looking at Dalfampridine plasma level.
  • Adverse Events [ Time Frame: Weeks 2, 4, 6, 8, 10 ]
    Patients will report on any adverse events they experienced that may or may not be due to treatment so that we may monitor safety.
 
Descriptive Information
Brief Title  ICMJE Dalfampridine and Gait in Spinocerebellar Ataxias
Official Title  ICMJE Therapeutic Effect of Dalfampridine on Gait Incoordination in Spinocerebellar Ataxias- A Randomized, Double-blinded, Placebo-controlled, Crossover Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinocerebellar Ataxias Type 1
  • Spinocerebellar Ataxias Type 2
  • Spinocerebellar Ataxias Type 3
  • Spinocerebellar Ataxias Type 6
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Dalfampridine
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Dalfampridine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2013)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2013)
30
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01811706
Other Study ID Numbers  ICMJE 20121107
1133511 ( Other Identifier: WIRB Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Acorda Therapeutics
Investigators  ICMJE
Principal Investigator: Guangbin Xia, MD, PhD University of Florida
PRS Account University of Florida
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP