NCT01811706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 12, 2015

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

March 6, 2013

Results QC Date

December 10, 2014

Last Update Submit

January 8, 2015

Conditions

Spinocerebellar Ataxias Type 1Spinocerebellar Ataxias Type 2Spinocerebellar Ataxias Type 3Spinocerebellar Ataxias Type 6

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 4 weeks after Dalfampridine or placebo

Secondary Outcomes (2)

  • Change in Scale of Assessment and Rating of Ataxia (SARA)

    Baseline and 4 weeks after Dalfampridine or placebo

  • Biomechanical Assessment of Gait (BAG)-Stride Length

    Baseline and 4 weeks after Dalfampridine or placebo

Study Arms (2)

Dalfampridine and then placebo

EXPERIMENTAL

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: DalfampridineDrug: Placebo

Placebo, Then Dalfampridine

EXPERIMENTAL

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: DalfampridineDrug: Placebo

Interventions

DalfampridineDRUG

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

Also known as: Ampyra
Dalfampridine and then placeboPlacebo, Then Dalfampridine
PlaceboDRUG

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

Also known as: Sugar Pill
Dalfampridine and then placeboPlacebo, Then Dalfampridine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Interventions

4-AminopyridineSugars

Intervention Hierarchy (Ancestors)

AminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbohydrates

Results Point of Contact

Title
Dr. Guangbin Xia, Assistant Professor
Organization
University of Florida
guangbin.xia@neurology.ufl.edu
352-273-5550

Study Officials

  • Guangbin Xia, MD, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 14, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 12, 2015

Results First Posted

January 12, 2015

Record last verified: 2015-01

Locations

US(1)