Trial · NCT01789047
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
NCT01789047, Phase 2, Terminated, Rush University Medical Center; results first posted 2019-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease. Trials, record NCT01789047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01789047
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
- NCT number
- NCT01789047
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Rush University Medical Center
- Conditions
- Idiopathic Parkinson's Disease, Drug Induced Dyskinesia
- Interventions
- Topiramate, Placebo, Amantadine
- First posted
- 2013-02-11
- Last updated
- 2019-04-16
- Results first posted
- 2019-04-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Unified Dyskinesia Rating Scale (UDysRS) | Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale | The Unified Dyskinesia Rating Scale (UDysRS) will be the primary outcome measure for this study. This choice is based on the outcome of the Validation of Dyskinesia Rating Scales study. In this study, the UDysRS was identified as the most sensitive scale to detect change in dyskinesia in an 8-week, double-blind, placebo-controlled trial of amatadine. The UDysRS utilizes rater information, patient self-report and objective measures of dyskinesia to provide assessments of impairment and disability due to dyskinesia. Score ranges are 0-108 with higher scores representing more severe impairment. |
| Other | Clinical Global Impression - Change Score | Assessed at Week 10 and 14 by blinded treating physician and subject | The Clinical Global Impression - Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with "no change". |
| Other | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Assessed at baseline, week 6, week 10 and week 14 | This is a 4-part scale that rates both non-motor and motor (including dyskinesia) aspects of Parkinson's disease. Parts of the scales will be completed by the blinded treating physician while assessing the subject and other parts will be self-completed by the subject |
| Other | Hoehn & Yahr Staging | Assessment completed at baseline, week 6, week 10 and week 14 | Hoehn \& Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Unified Dyskinesia Rating Scale (UDysRS) | Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale | Last Observation Carried Forward imputation | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Clinical Global Impression - Change Score | Assessed at Week 10 and 14 by blinded treating physician and subject | |||
| OTHER_PRE_SPECIFIED | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Assessed at baseline, week 6, week 10 and week 14 | |||
| OTHER_PRE_SPECIFIED | Hoehn & Yahr Staging | Assessment completed at baseline, week 6, week 10 and week 14 |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Unified Dyskinesia Rating Scale (UDysRS) | Topiramate | 4.00 | Standard Deviation 11.34 | units on a scale | |
| The Unified Dyskinesia Rating Scale (UDysRS) | Placebo (Sugar Pill) | 1.67 | Standard Deviation 10.27 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topiramate | 21 | |
| Overall Study | STARTED | Placebo (Sugar Pill) | 21 | |
| Overall Study | COMPLETED | Topiramate | 17 | |
| Overall Study | COMPLETED | Placebo (Sugar Pill) | 17 | |
| Overall Study | NOT COMPLETED | Topiramate | 4 | |
| Overall Study | NOT COMPLETED | Placebo (Sugar Pill) | 4 |
Source ClinicalTrials.gov
Adverse events56
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 | Balance instability | Nervous system disorders | Topiramate | 1 | 21 | 1 |
| other | Balance instability | Nervous system disorders | Placebo (Sugar Pill) | 1 | 21 | 1 |
| other | Biting lower lip | General disorders | Topiramate | 1 | 21 | 1 |
| other | Biting lower lip | General disorders | Placebo (Sugar Pill) | 0 | 21 | 0 |
| other | Blurred vision | Eye disorders | Topiramate | 3 | 21 | 3 |
| other | Blurred vision | Eye disorders | Placebo (Sugar Pill) | 1 | 21 | 1 |
| other | cognitive decline | Nervous system disorders | Topiramate | 0 | 21 | 0 |
| other | cognitive decline | Nervous system disorders | Placebo (Sugar Pill) | 1 | 21 | 1 |
| other | Common cold | Infections and infestations | Topiramate | 1 | 21 | 1 |
| other | Common cold | Infections and infestations | Placebo (Sugar Pill) | 0 | 21 | 0 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate | 0 | 21 |
| Total, all-cause mortality | Placebo (Sugar Pill) | 0 | 21 |
| Total, other adverse events | Topiramate | 16 | 21 |
| Total, other adverse events | Placebo (Sugar Pill) | 12 | 21 |
| Total, serious adverse events | Topiramate | 2 | 21 |
| Total, serious adverse events | Placebo (Sugar Pill) | 0 | 21 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Topiramate vs Placebo (Sugar Pill): deaths from any cause | Trial comparisons |
| Topiramate vs Placebo (Sugar Pill): serious adverse events | 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/NCT01789047
GET https://conductscience.org/api/trials/v1/NCT01789047/events?page=2