Parkinson's DiseaseNCT01003002
Natural History of Levodopa-Induced Dyskinesia (LID)
An observational study of 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 (LID). The severity of these movements can range from subtle to extremely debilitating. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Levodopa (delivered intravenously)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease
Who may be able to join
- Diagnosis of Parkinson's disease
- At least 21 years of age
- Levodopa treatment that will be orally initiated no more than 1 month after the screening visit for the study.
Who cannot join
- Unable to stand for 1 minute intervals
- Sensory deficits in the feet
- Significant cognitive impairment
- Unstable medical or psychiatric conditions (including hallucinations)
- History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Determining the Natural History of Levodopa-Induced Dyskinesia (LID)
Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias (LID). The severity of these movements can range from subtle to extremely debilitating. These movements may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the occurrence rate of LID range from 12 % to 100% after one year of levodopa treatment. These estimates used reporting mechanisms such as self-report and doctor-reported. These reporting mechanisms are not reliable. We will use an objective measure of dyskinesia in the first 5 years of treatment for Parkinson's disease. The purpose of this protocol is to use an objective measure to estimate dyskinesia onset.
Read the detailed description
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) 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. Current estimates of the prevalence of LID widely range from 12 % to 100% affected after one year. The purpose of this study is to estimate the median onset time of levodopa induced dyskinesia in newly treated Parkinson's disease patients. All participants will complete seven overnight visits at the OCTRI Inpatient unit over 5 years. 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.
- Conditions
- Parkinson's Disease
- Being tested
- Levodopa (delivered intravenously)
- Keywords
- Parkinson's disease, Dyskinesia, Movement Disorders
- Medical subject headings
- Parkinson Disease, Dyskinesias, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa (delivered intravenously)Drug
One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.
| Study group | Role | What they receive |
|---|---|---|
| PD Cohort | The cohort for this study is Parkinson's disease patients that are beginning oral levodopa treatment within one month of the screening visit. This cohort has not previously (to the screening visit) been treated with oral levodopa. Receives: Drug: Levodopa (delivered intravenously) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levodopa-Induced Dyskinesia
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startDec 2010
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Funding not secured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Clinical and Translational Research Institute
- Investigators
- Kathryn Chung, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003002
- Sponsor's protocol ID
- e4773
- Status last verified
- Oct 2009
- First submitted
- 27 Oct 2009
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller T, Woitalla D, Russ H, Hock K, Haeger DA. Prevalence and treatment strategies of dyskinesia in patients with Parkinson's disease. J Neural Transm (Vienna). 2007;114(8):1023-6. doi: 10.1007/s00702-007-0718-4. Epub 2007 Apr 10.
PubMed 17417738Parkinson Study Group. Pramipexole vs levodopa as initial treatment for Parkinson disease: A randomized controlled trial. Parkinson Study Group. JAMA. 2000 Oct 18;284(15):1931-8. doi: 10.1001/jama.284.15.1931.
PubMed 11035889Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.
PubMed 10816186Nutt JG, Carter JH, Lea ES, Sexton GJ. Evolution of the response to levodopa during the first 4 years of therapy. Ann Neurol. 2002 Jun;51(6):686-93. doi: 10.1002/ana.10189.
PubMed 12112073McColl CD, Reardon KA, Shiff M, Kempster PA. Motor response to levodopa and the evolution of motor fluctuations in the first decade of treatment of Parkinson's disease. Mov Disord. 2002 Nov;17(6):1227-34. doi: 10.1002/mds.10244.
PubMed 12465061
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Natural History of Levodopa-Induced Dyskinesia (LID)
- ClinicalTrials.gov ID
- NCT01003002
- Acronym / sponsor ID
- e4773
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Dyskinesia, Movement Disorders
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding not secured.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Oregon Clinical and Translational Research Institute
- Study start
- Dec 2010
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
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 (LID). The severity of these movements can range from subtle to extremely debilitating. These movements may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the occurrence rate of LID range from 12 % to 100% after one year of levodopa treatment. These estimates used reporting mechanisms such as self-report and doctor-reported. These reporting mechanisms are not reliable. We will use an objective measure of dyskinesia in the first 5 years of treatment for Parkinson's disease. The purpose of this protocol is to use an objective measure to estimate dyskinesia onset.
Detailed description
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) 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. Current estimates of the prevalence of LID widely range from 12 % to 100% affected after one year. The purpose of this study is to estimate the median onset time of levodopa induced dyskinesia in newly treated Parkinson's disease patients. All participants will complete seven overnight visits at the OCTRI Inpatient unit over 5 years. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD Cohort | – | Drug: Levodopa (delivered intravenously)The cohort for this study is Parkinson's disease patients that are beginning oral levodopa treatment within one month of the screening visit. This cohort has not previously (to the screening visit) been treated with oral levodopa. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease
Key inclusion criteria (3 listed)
- Diagnosis of Parkinson's disease
- At least 21 years of age
- Levodopa treatment that will be orally initiated no more than 1 month after the screening visit for the study.
Key exclusion criteria (5 listed)
- Unable to stand for 1 minute intervals
- Sensory deficits in the feet
- Significant cognitive impairment
- Unstable medical or psychiatric conditions (including hallucinations)
- History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa)
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 |
|---|---|---|
| Levodopa (delivered intravenously)One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100. | Drug | PD Cohort |
Primary outcome
Levodopa-Induced Dyskinesia
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Results publication: PubMed 17417738Muller T, Woitalla D, Russ H, Hock K, Haeger DA. Prevalence and treatment strategies of dyskinesia in patients with Parkinson's disease. J Neural Transm (Vienna). 2007;114(8):1023-6. doi: 10.1007/s00702-007-0718-4. Epub 2007 Apr 10.
- Results publication: PubMed 11035889Parkinson Study Group. Pramipexole vs levodopa as initial treatment for Parkinson disease: A randomized controlled trial. Parkinson Study Group. JAMA. 2000 Oct 18;284(15):1931-8. doi: 10.1001/jama.284.15.1931.
- Results publication: PubMed 10816186Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.
- Results publication: PubMed 12112073Nutt JG, Carter JH, Lea ES, Sexton GJ. Evolution of the response to levodopa during the first 4 years of therapy. Ann Neurol. 2002 Jun;51(6):686-93. doi: 10.1002/ana.10189.
- Results publication: PubMed 12465061McColl CD, Reardon KA, Shiff M, Kempster PA. Motor response to levodopa and the evolution of motor fluctuations in the first decade of treatment of Parkinson's disease. Mov Disord. 2002 Nov;17(6):1227-34. doi: 10.1002/mds.10244.
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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 and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 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: withdrawn, as of the sponsor's last update on 6 Apr 2016. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Levodopa-Induced Dyskinesia (time frame: 5 years). 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 NCT01003002, 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 6 Apr 2016.