Trial · NCT01491022
A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
NCT01491022, Phase 1, Phase 2, Completed, University of Miami; results first posted 2017-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease. Trials, record NCT01491022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01491022
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
- NCT number
- NCT01491022
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Parkinson's Disease
- Interventions
- Ampyra first, then Placebo, placebo first, then Ampyra
- First posted
- 2011-12-13
- Last updated
- 2018-01-02
- Results first posted
- 2017-04-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Velocity | baseline and 4 weeks | The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system. |
| Secondary | United Parkinson's Disease Rating Scale Score(UPDRS) , | 4 weeks | change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse. |
| Secondary | Freezing of Gait Questionnaire (FOGQ) | 4 weeks | change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired |
| Secondary | Timed Up and Go (TUG) Score | 4 weeks | time required to perform TUG. |
| Secondary | Timed 25-foot Walk Test (T25FW) | 4 weeks | time required to perform T25FW. |
| Secondary | Change in Stride Legth | 4 weeks | change in stride length as measured by 3 D capture analysis |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Velocity | baseline and 4 weeks | m/s | MEAN | |
| SECONDARY | United Parkinson's Disease Rating Scale Score(UPDRS) , | 4 weeks | units on a scale | MEAN | |
| SECONDARY | Freezing of Gait Questionnaire (FOGQ) | 4 weeks | units on a scale | MEAN | |
| SECONDARY | Timed Up and Go (TUG) Score | 4 weeks | seconds | MEAN | |
| SECONDARY | Timed 25-foot Walk Test (T25FW) | 4 weeks | seconds | MEAN | |
| SECONDARY | Change in Stride Legth | 4 weeks | meters | 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 Velocity | Ampyra | 0.03 | Standard Deviation 0.03 | m/s | |
| Change in Velocity | Placebo | 0.05 | Standard Deviation 0.03 | m/s | |
| United Parkinson's Disease Rating Scale Score(UPDRS) , | Ampyra | 35.22 | Standard Error 14.4 | units on a scale | |
| United Parkinson's Disease Rating Scale Score(UPDRS) , | Placebo | 35.55 | Standard Error 13.7 | units on a scale | |
| Freezing of Gait Questionnaire (FOGQ) | Ampyra Then Placebo | 13.16 | Standard Deviation 4.9 | units on a scale | |
| Freezing of Gait Questionnaire (FOGQ) | Placebo Then Ampyra | 13.4 | Standard Deviation 3.7 | units on a scale | |
| Timed Up and Go (TUG) Score | Ampyra Then Placebo | 23.25 | Standard Error 15.4 | seconds | |
| Timed Up and Go (TUG) Score | Placebo Then Ampyra | 20.6 | Standard Error 15.3 | seconds | |
| Timed 25-foot Walk Test (T25FW) | Ampyra Then Placebo | 11.6 | Standard Error 5.0 | seconds | |
| Timed 25-foot Walk Test (T25FW) | Placebo Then Ampyra | 11.8 | Standard Error 6.5 | seconds |
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 |
|---|---|---|---|---|
| Intervention 1 | STARTED | Ampyra Then Placebo | 10 | |
| Intervention 1 | STARTED | Placebo Then Ampyra | 12 | |
| Intervention 1 | COMPLETED | Ampyra Then Placebo | 9 | |
| Intervention 1 | COMPLETED | Placebo Then Ampyra | 11 | |
| Intervention 1 | NOT COMPLETED | Ampyra Then Placebo | 1 | |
| Intervention 1 | NOT COMPLETED | Placebo Then Ampyra | 1 | |
| 2 Week Washout | STARTED | Ampyra Then Placebo | 9 | |
| 2 Week Washout | STARTED | Placebo Then Ampyra | 11 | |
| 2 Week Washout | COMPLETED | Ampyra Then Placebo | 9 | |
| 2 Week Washout | COMPLETED | Placebo Then Ampyra | 11 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events6
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 | dizzines | Nervous system disorders | Ampyra | 4 | 22 | 4 |
| other | dizzines | Nervous system disorders | Placebo | 1 | 22 | 1 |
| other | urinary tract infection | Infections and infestations | Ampyra | 2 | 22 | 2 |
| other | urinary tract infection | Infections and infestations | Placebo | 1 | 22 | 1 |
| other | balance worsening | Nervous system disorders | Ampyra | 2 | 22 | 2 |
| other | balance worsening | Nervous system disorders | Placebo | 0 | 22 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ampyra | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ampyra | 5 | 22 |
| Total, other adverse events | Placebo | 2 | 22 |
| Total, serious adverse events | Ampyra | 0 | 22 |
| Total, serious adverse events | Placebo | 0 | 22 |
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 |
|---|
| Ampyra 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/NCT01491022
GET https://conductscience.org/api/trials/v1/NCT01491022/registered