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Parkinson DiseasePhase 2NCT00096720

Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease

A Phase 2 study testing levodopa, Mirapex (pramipexole) and [123I]ß-CIT and SPECT imaging in people with Parkinson Disease and Parkinsonian Syndrome, run by Institute for Neurodegenerative Disorders at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson Disease, Parkinsonian Syndrome
What is being tested?
levodopa, Mirapex (pramipexole) and [123I]ß-CIT and SPECT imaging
Type of treatment
Surgery or procedure
How many people
112 participants
Where
13 sitesUnited States
Study dates
Feb 2004to May 2007
Phase
Phase 2
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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 30 years or older at time of Parkinson Disease (PD) diagnosis
  • clinical diagnosis of PD of equal to or less than 7.5 years
  • Normal laboratory screening

Who cannot join

  • Participant is pregnant
  • Participant has atypical or drug induced PD
  • Participant has significant dementia

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Parkinson's Disease and Movement Disorders Center of Albany Medical College

    Albany, New York, 12205

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Lahey Clinic Medical Center

    Burlington, Massachusetts, 01805

  • Northwestern University

    Chicago, Illinois, 60611

  • RUSH University Medical Center

    Chicago, Illinois, 60612

  • Duke University

    Durham, North Carolina, 27705

  • Colorado Neurology, PC

    Englewood, Colorado, 80113

  • University of Florida Movement Disorders Center

    Gainesville, Florida, 32610

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107

  • NeuroHealth, Inc.

    Warwick, Rhode Island, 02886

Other trials in United States

About this study

Official title: Investigating Effects of Short-term Treatment With Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson's

Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.

Read the detailed description

Brain imaging will be conducted three times during this study. Study participants will travel to IND for [123I]ß-CIT and SPECT imaging (scan 1). Subjects will be randomized to no treatment, treatment with either levodopa, or treatment with Mirapex and undergo treatment for a period of 12 weeks. Subjects will return to IND for [123I]ß-CIT and SPECT imaging (scan 2) after 12 weeks of treatment and withdraw from the medication following the scan. Eight to 12 weeks after medication withdrawal, a final [123I]ß-CIT and SPECT imaging study (scan 3) will be performed at IND. The imaging outcome, striatal uptake of [123I]ß-CIT, from scan 1 (untreated) and scan 2 (treated with levodopa or pramipexole) will be compared to determine if there is a significant change in the uptake of the marker that may be attributed to levodopa or pramipexole treatment. In addition, scan 3 will be compared to scan 2 to determine the duration and reversibility of any regulatory effect that occurs. The subjects will be randomized, but not blinded to study drug assignment. The imaging technologist and all imaging analyses will be performed by investigators blinded to study drug assignment.

Being tested
levodopa, Mirapex (pramipexole), [123I]ß-CIT and SPECT imaging
Keywords
parkinson, brain imaging, diagnosis
Medical subject headings
Parkinson Disease, Parkinsonian Disorders, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • levodopaDrug

  • Mirapex (pramipexole)Drug

  • [123I]ß-CIT and SPECT imagingProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in outcomes from scan 1 to scan 2

Secondary outcomes (1)

  1. Change in outcomes from scan 2 to scan 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2004 (estimated)
  2. Study startFeb 2004
  3. Study completionMay 2007

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096720
Sponsor's protocol ID
INSPECT
Status last verified
May 2007
First submitted
12 Nov 2004
Last updated
29 Sep 2010
Results posted
No
Data monitoring committee
No

Publications

  • Ahlskog JE. Slowing Parkinson's disease progression: recent dopamine agonist trials. Neurology. 2003 Feb 11;60(3):381-9. doi: 10.1212/01.wnl.0000044047.58984.2f.

    PubMed 12580184

  • Ahlskog JE, Uitti RJ, O'Connor MK, Maraganore DM, Matsumoto JY, Stark KF, Turk MF, Burnett OL. The effect of dopamine agonist therapy on dopamine transporter imaging in Parkinson's disease. Mov Disord. 1999 Nov;14(6):940-6. doi: 10.1002/1531-8257(199911)14:63.0.co;2-y.

    PubMed 10584667

  • Brucke T, Asenbaum S, Pirker W, Djamshidian S, Wenger S, Wober C, Muller C, Podreka I. Measurement of the dopaminergic degeneration in Parkinson's disease with [123I] beta-CIT and SPECT. Correlation with clinical findings and comparison with multiple system atrophy and progressive supranuclear palsy. J Neural Transm Suppl. 1997;50:9-24.

    PubMed 9120429

  • Fahn S. Is levodopa toxic? Neurology. 1996 Dec;47(6 Suppl 3):S184-95. doi: 10.1212/wnl.47.6_suppl_3.184s. No abstract available.

    PubMed 8959987

  • Guttman M, Stewart D, Hussey D, Wilson A, Houle S, Kish S. Influence of L-dopa and pramipexole on striatal dopamine transporter in early PD. Neurology. 2001 Jun 12;56(11):1559-64. doi: 10.1212/wnl.56.11.1559.

    PubMed 11402115

  • Innis RB, Seibyl JP, Scanley BE, Laruelle M, Abi-Dargham A, Wallace E, Baldwin RM, Zea-Ponce Y, Zoghbi S, Wang S, et al. Single photon emission computed tomographic imaging demonstrates loss of striatal dopamine transporters in Parkinson disease. Proc Natl Acad Sci U S A. 1993 Dec 15;90(24):11965-9. doi: 10.1073/pnas.90.24.11965.

    PubMed 8265656

  • Innis RB, Marek KL, Sheff K, Zoghbi S, Castronuovo J, Feigin A, Seibyl JP. Effect of treatment with L-dopa/carbidopa or L-selegiline on striatal dopamine transporter SPECT imaging with [123I]beta-CIT. Mov Disord. 1999 May;14(3):436-42. doi: 10.1002/1531-8257(199905)14:33.0.co;2-j.

    PubMed 10348466

  • Little KY, Gorebig J, Carroll FI, Mapili J, Meador-Woodruff JH. Lack of dopamine receptor agonists effect on striatal dopamine transporter binding sites. Brain Res. 1996 Dec 2;742(1-2):313-6. doi: 10.1016/s0006-8993(96)01033-5.

    PubMed 9117410

  • Marek K, Innis R, van Dyck C, Fussell B, Early M, Eberly S, Oakes D, Seibyl J. [123I]beta-CIT SPECT imaging assessment of the rate of Parkinson's disease progression. Neurology. 2001 Dec 11;57(11):2089-94. doi: 10.1212/wnl.57.11.2089.

    PubMed 11739831

  • Morrish PK, Rakshi JS, Bailey DL, Sawle GV, Brooks DJ. Measuring the rate of progression and estimating the preclinical period of Parkinson's disease with [18F]dopa PET. J Neurol Neurosurg Psychiatry. 1998 Mar;64(3):314-9. doi: 10.1136/jnnp.64.3.314.

    PubMed 9527140

  • Nurmi E, Bergman J, Eskola O, Solin O, Hinkka SM, Sonninen P, Rinne JO. Reproducibility and effect of levodopa on dopamine transporter function measurements: a [18F]CFT PET study. J Cereb Blood Flow Metab. 2000 Nov;20(11):1604-9. doi: 10.1097/00004647-200011000-00010.

    PubMed 11083235

  • Parkinson Study Group. Dopamine transporter brain imaging to assess the effects of pramipexole vs levodopa on Parkinson disease progression. JAMA. 2002 Apr 3;287(13):1653-61. doi: 10.1001/jama.287.13.1653.

    PubMed 11926889

  • Fahn S; Parkinson Study Group. Does levodopa slow or hasten the rate of progression of Parkinson's disease? J Neurol. 2005 Oct;252 Suppl 4:IV37-IV42. doi: 10.1007/s00415-005-4008-5.

    PubMed 16222436

  • Rioux L, Frohna PA, Joyce JN, Schneider JS. The effects of chronic levodopa treatment on pre- and postsynaptic markers of dopaminergic function in striatum of parkinsonian monkeys. Mov Disord. 1997 Mar;12(2):148-58. doi: 10.1002/mds.870120204.

    PubMed 9087972

  • Schapira AH. Dopamine agonists and neuroprotection in Parkinson's disease. Eur J Neurol. 2002 Nov;9 Suppl 3:7-14. doi: 10.1046/j.1468-1331.9.s3.9.x.

    PubMed 12464116

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing levodopa, Mirapex (pramipexole) and [123I]ß-CIT and SPECT imaging in people with Parkinson Disease and Parkinsonian Syndrome, run by Institute for Neurodegenerative Disorders at 13 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in outcomes from scan 1 to scan 2. 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 NCT00096720, which also lists 17 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 29 Sep 2010.

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