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Trial record 28 of 121 for:    "spinocerebellar degenerations" OR "marinesco-sjogren syndrome"

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 Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Spinocerebellar Ataxias Type 1
Spinocerebellar Ataxias Type 2
Spinocerebellar Ataxias Type 3
Spinocerebellar Ataxias Type 6
Interventions: Drug: Dalfampridine
Drug: Placebo

  Participant Flow

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
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.

Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period

Placebo: Placebo will be administered orally every 12 hours, for a 4 week period.

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.

Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period

Placebo: Placebo will be administered orally every 12 hours, for a 4 week period.


Participant Flow for 3 periods

Period 1:   First Intervention ( 4 Weeks)
    Dalfampridine and Then Placebo   Placebo, Then Dalfampridine
STARTED   10   10 
COMPLETED   9   10 
NOT COMPLETED   1   0 
Adverse Event                1                0 

Period 2:   Washout ( 2 Weeks)
    Dalfampridine and Then Placebo   Placebo, Then Dalfampridine
STARTED   9   10 
COMPLETED   9   10 
NOT COMPLETED   0   0 

Period 3:   Second Intervention (4 Weeks)
    Dalfampridine and Then Placebo   Placebo, Then Dalfampridine
STARTED   9   10 
COMPLETED   9   10 
NOT COMPLETED   0   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
All Study Participants No text entered.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.9  (14.3) 
Gender 
[Units: Participants]
 
Female   8 
Male   12 
Region of Enrollment 
[Units: Participants]
 
United States   20 
T25FW at screening visit [1] 
[Units: Second]
Mean (Standard Deviation)
 25.5  (9.7) 
[1] Timed 25-Foot Walk (T25FW): The patient is directed to one end of a 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.
SARA at screening visit [1] 
[Units: Point]
Mean (Standard Deviation)
 11.1  (3.4) 
[1] 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.


  Outcome Measures

1.  Primary:   Change in Timed 25 Feet Walking Test (T25FW)   [ Time Frame: Baseline and 4 weeks after Dalfampridine or placebo ]

2.  Secondary:   Change in Scale of Assessment and Rating of Ataxia (SARA)   [ Time Frame: Baseline and 4 weeks after Dalfampridine or placebo ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Guangbin Xia, Assistant Professor
Organization: University of Florida
phone: 352-273-5550
e-mail: guangbin.xia@neurology.ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01811706     History of Changes
Other Study ID Numbers: 20121107
1133511 ( Other Identifier: WIRB Study Number )
First Submitted: March 6, 2013
First Posted: March 14, 2013
Results First Submitted: December 10, 2014
Results First Posted: January 12, 2015
Last Update Posted: January 12, 2015