Parkinson's DiseaseNCT00794313
Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease
A study testing Amantadine 300 mg, Topiramate and Sugar Pill in people with Parkinson's Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias. A drug called amantadine can reduce these movements. To date, there are no objective measures of these movements. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Amantadine 300 mg, Topiramate and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2010
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's Disease
- At least 21 years of age
- Must be taking Oral levodopa
- Must have dyskinesias by history or previous clinical observation
Who cannot join
- Significant cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA) score of < 25
- Subjects with unstable medical or psychiatric conditions (including hallucinations)
- Use of dopamine receptor blocking medications (e.g., neuroleptics, certain antiemetics, tetrabenazine)
- History of unstable medical conditions (ie active cardiovascular disease, recent unwellness or surgery etc.)
- Use of anticoagulants
- Current substance abuse
- Previous adverse event on amantadine
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias. A drug called amantadine can reduce these movements. To date, there are no objective measures of these movements. The purpose of this study is to measure the reduction of the movements by amantadine and/or topiramate using an objective measure.
Read the detailed description
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Currently, one of the very few treatments for these unwanted and involuntary movements is Amantadine. New options to treat dyskinesia would be clinically very valuable. In a previous study, we developed an objective measuring device to quantify dyskinesia.
All PD participants will receive all three of the drug treatment intervention (placebo, Amantadine 300 mg, Amantadine 300 mg plus Topiramate 150 mg). After 2 weeks of one drug treatment, the participants will complete an overnight visit at the OCTRI Inpatient unit. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100. The subjects will be split into 'high' and 'low' dose groups. Those who take <50 mg/hour of oral levodopa or levodopa equivalents will be considered 'low' dose subjects and will receive 1 mg/kg/hr of IV Levodopa during the study visits (1, 2, and 3). Those who administer > 50 mg/hr of oral levodopa to themselves normally will be considered 'high' dose subjects and will received 1.5 mg/kg/hr levodopa. Both groups will receive the infusion for two hours from 0900 - 1100. The study drug will be taken orally at 0800.
- Conditions
- Parkinson's Disease
- Being tested
- Amantadine 300 mg, Topiramate, Sugar Pill
- Keywords
- Parkinsons disease, dyskinesia, amantadine, efficacy
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amantadine 300 mgDrug
Amantadine, 300 mg, capsule, three times a day, two weeks
TopiramateDrug
Also called Topamax
Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week
Sugar PillDrug
sugar pill, capsule, three times a day, 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Amantadine | Experimental | Not described Receives: Drug: Amantadine 300 mg |
| Amantadine plus Topiramate | Experimental | Not described Receives: Drug: Amantadine 300 mg; Drug: Topiramate |
| Sugar Pill | Placebo comparator | Not described Receives: Drug: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forceplate AUC
Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.
Measured: Every 1/2 hour for 8 hour levodopa cycle
Secondary outcomes (1)
Modified Abnormal Involuntary Movement Scale Area Under the Curve
Area under the curve computed for whole body (total) mAIMS (Modified Abnormal Involuntary Movement Scale) scores at each time measurement. This is a commonly utilized scale that is completed by an observer who judges the severity of levodopa induced dyskinesia (LID) in 7 body parts (face, neck, trunk, both legs, and both arms). All body parts are rated separately on this 0 (none) to 4 (severe - markedly impairs activities) scale. Thus, the total score can range from 0 - 28 with 28 indicating the most severe LID. mAIMS ratings occur as the subject performs the cognitive task while standing on the force plate. mAIMS ratings are made every half hour during the levodopa (LD) dose cycle.
Measured: Measured every 1/2 hour for a levodopa dose cycle (starting 1 hour prior to infusion and ending 4 hours post 2-hour infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Funding Ended
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Anne Chung, Oregon Health and Science University
- Investigators
- Kathryn Chung, MD, Principal investigator, Oregon Health & Science University, Portland VA Medical CenterJohn G Nutt, MD, Principal investigator, Oregon Health & Science Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794313
- Sponsor's protocol ID
- e4717
- Status last verified
- Jan 2018
- First submitted
- 19 Nov 2008
- Last updated
- 1 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Snow BJ, Macdonald L, Mcauley D, Wallis W. The effect of amantadine on levodopa-induced dyskinesias in Parkinson's disease: a double-blind, placebo-controlled study. Clin Neuropharmacol. 2000 Mar-Apr;23(2):82-5. doi: 10.1097/00002826-200003000-00004.
PubMed 10803797Verhagen Metman L, Del Dotto P, van den Munckhof P, Fang J, Mouradian MM, Chase TN. Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease. Neurology. 1998 May;50(5):1323-6. doi: 10.1212/wnl.50.5.1323.
PubMed 9595981Del Dotto P, Pavese N, Gambaccini G, Bernardini S, Metman LV, Chase TN, Bonuccelli U. Intravenous amantadine improves levadopa-induced dyskinesias: an acute double-blind placebo-controlled study. Mov Disord. 2001 May;16(3):515-20. doi: 10.1002/mds.1112.
PubMed 11391748Hagell P, Widner H. Clinical rating of dyskinesias in Parkinson's disease: use and reliability of a new rating scale. Mov Disord. 1999 May;14(3):448-55. doi: 10.1002/1531-8257(199905)14:33.0.co;2-0.
PubMed 10348468da Silva-Junior FP, Braga-Neto P, Sueli Monte F, de Bruin VM. Amantadine reduces the duration of levodopa-induced dyskinesia: a randomized, double-blind, placebo-controlled study. Parkinsonism Relat Disord. 2005 Nov;11(7):449-52. doi: 10.1016/j.parkreldis.2005.05.008. Epub 2005 Sep 9.
PubMed 16154788
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00794313
- Acronym / sponsor ID
- e4717
- Conditions
- Parkinson's Disease
- Keywords
- Parkinsons disease, dyskinesia, amantadine, efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Ended
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Posted 11 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias. A drug called amantadine can reduce these movements. To date, there are no objective measures of these movements. The purpose of this study is to measure the reduction of the movements by amantadine and/or topiramate using an objective measure.
Detailed description
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Currently, one of the very few treatments for these unwanted and involuntary movements is Amantadine. New options to treat dyskinesia would be clinically very valuable. In a previous study, we developed an objective measuring device to quantify dyskinesia.
All PD participants will receive all three of the drug treatment intervention (placebo, Amantadine 300 mg, Amantadine 300 mg plus Topiramate 150 mg). After 2 weeks of one drug treatment, the participants will complete an overnight visit at the OCTRI Inpatient unit. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100. The subjects will be split into 'high' and 'low' dose groups. Those who take <50 mg/hour of oral levodopa or levodopa equivalents will be considered 'low' dose subjects and will receive 1 mg/kg/hr of IV Levodopa during the study visits (1, 2, and 3). Those who administer > 50 mg/hr of oral levodopa to themselves normally will be considered 'high' dose subjects and will received 1.5 mg/kg/hr levodopa. Both groups will receive the infusion for two hours from 0900 - 1100. The study drug will be taken orally at 0800.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amantadine | Experimental | Drug: Amantadine 300 mg |
| Amantadine plus Topiramate | Experimental | Drug: Amantadine 300 mg, Drug: Topiramate |
| Sugar Pill | Placebo comparator | Drug: Sugar Pill |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parkinson's Disease
- At least 21 years of age
- Must be taking Oral levodopa
- Must have dyskinesias by history or previous clinical observation
Key exclusion criteria (7 listed)
- Significant cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA) score of < 25
- Subjects with unstable medical or psychiatric conditions (including hallucinations)
- Use of dopamine receptor blocking medications (e.g., neuroleptics, certain antiemetics, tetrabenazine)
- History of unstable medical conditions (ie active cardiovascular disease, recent unwellness or surgery etc.)
- Use of anticoagulants
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 |
|---|---|---|
| Amantadine 300 mgAmantadine, 300 mg, capsule, three times a day, two weeks | Drug | Amantadine, Amantadine plus Topiramate |
| TopiramateAlso: TopamaxTopiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week | Drug | Amantadine plus Topiramate |
| Sugar Pillsugar pill, capsule, three times a day, 2 weeks | Drug | Sugar Pill |
Primary outcome
Forceplate AUC
Time frame: Every 1/2 hour for 8 hour levodopa cycle
Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.
1 secondary outcome
Modified Abnormal Involuntary Movement Scale Area Under the Curve
Time frame: Measured every 1/2 hour for a levodopa dose cycle (starting 1 hour prior to infusion and ending 4 hours post 2-hour infusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10803797Snow BJ, Macdonald L, Mcauley D, Wallis W. The effect of amantadine on levodopa-induced dyskinesias in Parkinson's disease: a double-blind, placebo-controlled study. Clin Neuropharmacol. 2000 Mar-Apr;23(2):82-5. doi: 10.1097/00002826-200003000-00004.
- Background: PubMed 9595981Verhagen Metman L, Del Dotto P, van den Munckhof P, Fang J, Mouradian MM, Chase TN. Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease. Neurology. 1998 May;50(5):1323-6. doi: 10.1212/wnl.50.5.1323.
- Background: PubMed 11391748Del Dotto P, Pavese N, Gambaccini G, Bernardini S, Metman LV, Chase TN, Bonuccelli U. Intravenous amantadine improves levadopa-induced dyskinesias: an acute double-blind placebo-controlled study. Mov Disord. 2001 May;16(3):515-20. doi: 10.1002/mds.1112.
- Background: PubMed 10348468Hagell P, Widner H. Clinical rating of dyskinesias in Parkinson's disease: use and reliability of a new rating scale. Mov Disord. 1999 May;14(3):448-55. doi: 10.1002/1531-8257(199905)14:33.0.co;2-0.
- Background: PubMed 16154788da Silva-Junior FP, Braga-Neto P, Sueli Monte F, de Bruin VM. Amantadine reduces the duration of levodopa-induced dyskinesia: a randomized, double-blind, placebo-controlled study. Parkinsonism Relat Disord. 2005 Nov;11(7):449-52. doi: 10.1016/j.parkreldis.2005.05.008. Epub 2005 Sep 9.
- Individual participant dataSharing planned: No
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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.
Kathryn Chung, MD principal investigator
Oregon Health & Science University, Portland VA Medical Center
John G Nutt, MD principal investigator
Oregon Health & Science Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amantadine 300 mg, Topiramate and Sugar Pill in people with Parkinson's Disease, run by Oregon Health and Science University at 1 site 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 4 inclusion and 7 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2017). 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?
Forceplate AUC (time frame: Every 1/2 hour for 8 hour levodopa cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794313, which also lists 5 linked publications.
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 1 Feb 2018.