Trial · NCT01811706
Dalfampridine and Gait in Spinocerebellar Ataxias
NCT01811706, Not applicable, Completed, University of Florida; results first posted 2015-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dalfampridine and Gait in Spinocerebellar Ataxias. Trials, record NCT01811706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01811706
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dalfampridine and Gait in Spinocerebellar Ataxias
- NCT number
- NCT01811706
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Spinocerebellar Ataxias Type 1, Spinocerebellar Ataxias Type 2, Spinocerebellar Ataxias Type 3, Spinocerebellar Ataxias Type 6
- Interventions
- Dalfampridine, Placebo
- First posted
- 2013-03-14
- Last updated
- 2015-01-12
- Results first posted
- 2015-01-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Timed 25 Feet Walking Test (T25FW) | 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 | Change in Scale of Assessment and Rating of Ataxia (SARA) | 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. |
| Secondary | Biomechanical Assessment of Gait (BAG)-Stride Length | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Timed 25 Feet Walking Test (T25FW) | Baseline and 4 weeks after Dalfampridine or placebo | Patient with spinocerebellar ataxia (SCA) 1, 2, 3, or 6 | second | MEAN |
| SECONDARY | Change in Scale of Assessment and Rating of Ataxia (SARA) | Baseline and 4 weeks after Dalfampridine or placebo | point | MEAN | |
| SECONDARY | Biomechanical Assessment of Gait (BAG)-Stride Length | Baseline and 4 weeks after Dalfampridine or placebo | cm | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Timed 25 Feet Walking Test (T25FW) | Dalfampridine | T25FW at baseline | 23.7 | Standard Deviation 10.1 | second |
| Change in Timed 25 Feet Walking Test (T25FW) | Placebo | T25FW at baseline | 24.4 | Standard Deviation 10.1 | second |
| Change in Timed 25 Feet Walking Test (T25FW) | Dalfampridine | Change from baseline at 4 weeks | -1.1 | Standard Deviation 4.7 | second |
| Change in Timed 25 Feet Walking Test (T25FW) | Placebo | Change from baseline at 4 weeks | -0.3 | Standard Deviation 4.8 | second |
| Change in Scale of Assessment and Rating of Ataxia (SARA) | Dalfampridine | SARA at baseline | 10.0 | Standard Deviation 3.5 | point |
| Change in Scale of Assessment and Rating of Ataxia (SARA) | Placebo | SARA at baseline | 10.1 | Standard Deviation 3.3 | point |
| Change in Scale of Assessment and Rating of Ataxia (SARA) | Dalfampridine | Change from baseline at week 4 | 0.6 | Standard Deviation 1.5 | point |
| Change in Scale of Assessment and Rating of Ataxia (SARA) | Placebo | Change from baseline at week 4 | 0.8 | Standard Deviation 1.8 | point |
| Biomechanical Assessment of Gait (BAG)-Stride Length | Dalfampridine | Sstride Length at baseline | 112.7 | Standard Deviation 29.4 | cm |
| Biomechanical Assessment of Gait (BAG)-Stride Length | Placebo | Sstride Length at baseline | 111.8 | Standard Deviation 30.0 | cm |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention ( 4 Weeks) | STARTED | Dalfampridine and Then Placebo | 10 | |
| First Intervention ( 4 Weeks) | STARTED | Placebo, Then Dalfampridine | 10 | |
| First Intervention ( 4 Weeks) | COMPLETED | Dalfampridine and Then Placebo | 9 | |
| First Intervention ( 4 Weeks) | COMPLETED | Placebo, Then Dalfampridine | 10 | |
| First Intervention ( 4 Weeks) | NOT COMPLETED | Dalfampridine and Then Placebo | 1 | |
| First Intervention ( 4 Weeks) | NOT COMPLETED | Placebo, Then Dalfampridine | 0 | |
| Washout ( 2 Weeks) | STARTED | Dalfampridine and Then Placebo | 9 | |
| Washout ( 2 Weeks) | STARTED | Placebo, Then Dalfampridine | 10 | |
| Washout ( 2 Weeks) | COMPLETED | Dalfampridine and Then Placebo | 9 | |
| Washout ( 2 Weeks) | COMPLETED | Placebo, Then Dalfampridine | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | headache | Nervous system disorders | Dalfampridine | 3 | 20 | 3 |
| other | headache | Nervous system disorders | Placebo | 1 | 19 | 1 |
| other | lethargy | Nervous system disorders | Dalfampridine | 1 | 20 | 1 |
| other | lethargy | Nervous system disorders | Placebo | 0 | 19 | 0 |
| other | dental caries | Gastrointestinal disorders | Dalfampridine | 1 | 20 | 1 |
| other | dental caries | Gastrointestinal disorders | Placebo | 0 | 19 | 0 |
| other | pain in extremity | Musculoskeletal and connective tissue disorders | Dalfampridine | 1 | 20 | 1 |
| other | pain in extremity | Musculoskeletal and connective tissue disorders | Placebo | 0 | 19 | 0 |
| other | vertigo | Ear and labyrinth disorders | Dalfampridine | 0 | 20 | 0 |
| other | vertigo | Ear and labyrinth disorders | Placebo | 1 | 19 | 1 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalfampridine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dalfampridine | 7 | 20 |
| Total, other adverse events | Placebo | 8 | 19 |
| Total, serious adverse events | Dalfampridine | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dalfampridine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01811706
GET https://conductscience.org/api/trials/v1/NCT01811706/events?page=2