Idiopathic Parkinson's DiseasePhase 2TOP-DYSKNCT01789047
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
A Phase 2 study testing Topiramate and Amantadine in people with Idiopathic Parkinson's Disease and Drug Induced Dyskinesia, run by Rush University Medical Center at 5 sites in United States.
Trial summary
The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on amantadine. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Idiopathic Parkinson's Disease, Drug Induced Dyskinesia
- What is being tested?
- Topiramate and Amantadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2013to Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria
- Current age between 30-90
- Clinically pertinent dyskinesias defined by Clinical Global Impression - Severity (CGI-s) score (see attachment) > 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. *
- Stable doses of all antiparkinsonian medications for at least 4 weeks
- Stable treatment with at least 200 mg amantadine for at least 4 weeks.
- Presence of a caregiver willing to participate in the study
Show all 9Show fewer
- In the opinion of the enrolling investigator, the subject will be able to maintain current dosing schedule of antiparkinsonian drugs for the duration of the trial.
- Subjects must be free of dementia, depression and psychosis as determined by clinical examination.
- The subject must be willing to participate in all study related activities and visits.
Who cannot join
- Any subjects with clinical evidence suggestive of an atypical or secondary form of Parkinson's Disease
- Any subject who, in the opinion of the Principal Investigator, has a concomitant medical illness which would preclude them from being treated with amantadine,
- Any subject who, in the opinion of the Principal Investigator, will be unable to maintain current stable dosing of their anti-parkinsonian medications for the duration of the trial,
- Any subject with evidence for dementia, depression, or psychosis, as determined by clinical examination.
- Any subject who has not signed informed consent, or unable or unwilling to participate in all of the study related activities.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama
Birmingham, Alabama, 35233
Rush University Medical Center
Chicago, Illinois, 60612
Duke University
Durham, North Carolina, 27705
Oregon Health Sciences University
Portland, Oregon, 97201
University of South Florida
Tampa, Florida, 33612
About this study
The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on amantadine.
Read the detailed description
We conducted a randomized placebo controlled trial of topiramate in PD dyskinetic subjects already on amantadine but with continuing dyskinesia. Topiramate or placebo was introduced in blinded fashion with a gradual titration (topiramate 25-150 mg/d) over 6 weeks and then a maintenance period of 8 weeks. The primary outcome of interest was change from baseline to end of study in total Unified Dyskinesia Rating Scale (UDysRS) score using Intention to Treat analysis.
- Being tested
- Topiramate, Placebo, Amantadine
- Keywords
- Parkinson's disease, dyskinesia, Indonesia, amantadine
- Medical subject headings
- Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Also called Topamax
Topiramate as adjunct to amantadine
PlaceboDrug
Also called sugar pill
Placebo control
AmantadineDrug
Also called Symmetrel
Existing treatment for all participants
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Active comparator | Topiramate as adjunct to amantadine. Receives: Drug: Topiramate; Drug: Amantadine |
| Placebo (sugar pill) | Placebo comparator | Placebo Receives: Drug: Placebo; Drug: Amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Unified Dyskinesia Rating Scale (UDysRS)
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.
Measured: Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Sponsor withdrew support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Christopher G. Goetz, MD, Rush University Medical Center
- Investigators
- Christopher G Goetz, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789047
- Sponsor's protocol ID
- TOP-DYSK
- Acronym
- TOP-DYSK
- Status last verified
- Mar 2019
- First submitted
- 7 Feb 2013
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01789047
- Acronym / sponsor ID
- TOP-DYSK / TOP-DYSK
- Keywords
- Parkinson's disease, dyskinesia, Indonesia, amantadine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew support
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Mar 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on amantadine.
Detailed description
We conducted a randomized placebo controlled trial of topiramate in PD dyskinetic subjects already on amantadine but with continuing dyskinesia. Topiramate or placebo was introduced in blinded fashion with a gradual titration (topiramate 25-150 mg/d) over 6 weeks and then a maintenance period of 8 weeks. The primary outcome of interest was change from baseline to end of study in total Unified Dyskinesia Rating Scale (UDysRS) score using Intention to Treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Active comparator | Drug: Topiramate, Drug: AmantadineTopiramate as adjunct to amantadine. |
| Placebo (sugar pill) | Placebo comparator | Drug: Placebo, Drug: AmantadinePlacebo |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria
- Current age between 30-90
- Clinically pertinent dyskinesias defined by Clinical Global Impression - Severity (CGI-s) score (see attachment) > 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. *
- Stable doses of all antiparkinsonian medications for at least 4 weeks
- Stable treatment with at least 200 mg amantadine for at least 4 weeks.
Key exclusion criteria (5 listed)
- Any subjects with clinical evidence suggestive of an atypical or secondary form of Parkinson's Disease
- Any subject who, in the opinion of the Principal Investigator, has a concomitant medical illness which would preclude them from being treated with amantadine,
- Any subject who, in the opinion of the Principal Investigator, will be unable to maintain current stable dosing of their anti-parkinsonian medications for the duration of the trial,
- Any subject with evidence for dementia, depression, or psychosis, as determined by clinical examination.
- Any subject who has not signed informed consent, or unable or unwilling to participate in all of the study related activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopiramateAlso: TopamaxTopiramate as adjunct to amantadine | Drug | Topiramate |
| PlaceboAlso: sugar pillPlacebo control | Drug | Placebo (sugar pill) |
| AmantadineAlso: SymmetrelExisting treatment for all participants | Drug | Placebo (sugar pill), Topiramate |
Primary outcome
The Unified Dyskinesia Rating Scale (UDysRS)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher G Goetz, MD principal investigator
Rush University Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topiramate and Amantadine in people with Idiopathic Parkinson's Disease and Drug Induced Dyskinesia, run by Rush University Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Unified Dyskinesia Rating Scale (UDysRS) (time frame: Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.