Parkinson DiseasePhase 1NCT01788696
Pilot Study To Assess Effect of Treatment and Adherence in PD Subjects
A Phase 1 study testing Group A - Early Imaging and Group B - Delayed Imaging in people with Parkinson Disease, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool in the management of early Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Group A - Early Imaging and Group B - Delayed Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2015
- Phase
- Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80;
- diagnosis of idiopathic PD exhibiting at least 2 of 3 cardinal signs (bradykinesia, rigidity and resting tremor);
- maximum duration of previous exposure to anti-parkinsonian therapy being < 8 weeks;
- ability to signed informed consent;
- willingness and ability to complete medication diary and questionnaires;
- if a female subject of child-bearing potential, the use of an effective method of contraception.
Who cannot join
- current treatment with anti-parkinsonian medication;
- previous treatment with anti-parkinsonian medication for greater than 8 weeks;
- inability to complete questionnaires;
- unwillingness to complete all questionnaires and medication diary;
- subjects with secondary causes of parkinsonism;
- participant has evidence of clinical significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder;
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- positive serum/urine pregnancy test at any time during the study period;
- the participant has a history of alcohol, narcotic, or any other drug abuse as defined by the DSM-IV within the past 2 years;
- participation in a concurrent PD trial within 60 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health Center
Durham, North Carolina, 27705
About this study
Official title: Assessment of the Effect of Treatment Pathways, Adherence, and Treatment Efficacy in Parkinson's Disease Subjects Randomized to SPECT Imaging of the Dopamine Transporter (Ioflupane I123 Injection)
The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool in the management of early Parkinson's disease (PD).
Read the detailed description
The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as DaTscan. DaTscan is FDA approved.
- Conditions
- Parkinson Disease
- Being tested
- Group A - Early Imaging, Group B - Delayed Imaging
- Keywords
- Parkinsonism, Idiopathic Parkinson Disease
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A - Early ImagingRadiation
Also called [123I]-FP-CIT SPECT
Total of 3 scans
Group B - Delayed ImagingRadiation
Also called [123I]-FP-CIT SPECT
Total of 2 scans
| Study group | Role | What they receive |
|---|---|---|
| Group A - Early Imaging | Active comparator | Group A will receive SPECT imaging 3 times during the study. The first scan will take place prior to the initiation of any treatment, followed by scans at week 26 and week 52. Receives: Radiation: Group A - Early Imaging |
| Group B - Delayed Imaging | Active comparator | Group B will receive SPECT imaging 2 times during the study. Group B will not have the first scan (prior to the initiation of any treatment). Scan will take place at week 26 and week 52. Receives: Radiation: Group B - Delayed Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient adherence to treatment plan
Patient and treating physician agree on a treatment plan at visit 3. Patient adherence to medications will be evaluated based on pill count at each follow-up study visit. Additionally, each patient will record their adherence to therapy on the Patient Expectations and Disease-related Questionnaire (PEDQ) at each follow-up study visit, allowing the study team to track compliance with pharmacologic therapy as well as treatments including therapy exercise plans.
Measured: 1 year
Secondary outcomes (5)
Unified Parkinson Disease Rating Scale (UPDRS)
Other outcome measures will be between any group differences in UPDRS.
Measured: 1 year
Life Orientation Test - Revised (LOT-R)
Other outcome measures will be between any group differences in LOT-R. This test assesses individual differences in generalized optimism versus pessimism.
Measured: 1 year
Marlowe - Crowne Social Desirability Scale (MCSD)
Other outcome measures will be between any group differences in MCSD. This test assesses the extent to which individuals attempt to depict themselves as similar to the norms and standards of their society and community.
Measured: 1 year
Obsessive - Compulsive Inventory (OCI)
Other outcome measures will be between any group differences in OCI. This self-report scale assesses distress from symptoms commonly experienced in obsessive-compulsive disorder.
Measured: 1 year
Expectation of Global Response (EGCR)
Other outcome measures will be between any group differences in EGCR.
Measured: 1 year
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 startJun 2012
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Duke 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Patrick Hickey, DO, Principal investigator, Duke University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788696
- Sponsor's protocol ID
- Pro00036503
- Status last verified
- Jun 2015
- First submitted
- 7 Feb 2013
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Treatment Pathways, Adherence, and Treatment Efficacy in Parkinson's Disease Subjects Randomized to SPECT Imaging of the Dopamine Transporter (Ioflupane I123 Injection)
- ClinicalTrials.gov ID
- NCT01788696
- Acronym / sponsor ID
- Pro00036503
- Conditions
- Parkinson Disease
- Keywords
- Parkinsonism, Idiopathic Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Jun 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Feb 2013 (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.
The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool in the management of early Parkinson's disease (PD).
Detailed description
The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as DaTscan. DaTscan is FDA approved.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Early Imaging | Active comparator | Radiation: Group A - Early ImagingGroup A will receive SPECT imaging 3 times during the study. The first scan will take place prior to the initiation of any treatment, followed by scans at week 26 and week 52. |
| Group B - Delayed Imaging | Active comparator | Radiation: Group B - Delayed ImagingGroup B will receive SPECT imaging 2 times during the study. Group B will not have the first scan (prior to the initiation of any treatment). Scan will take place at week 26 and week 52. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18-80;
- diagnosis of idiopathic PD exhibiting at least 2 of 3 cardinal signs (bradykinesia, rigidity and resting tremor);
- maximum duration of previous exposure to anti-parkinsonian therapy being < 8 weeks;
- ability to signed informed consent;
- willingness and ability to complete medication diary and questionnaires;
Key exclusion criteria (9 listed)
- current treatment with anti-parkinsonian medication;
- previous treatment with anti-parkinsonian medication for greater than 8 weeks;
- inability to complete questionnaires;
- unwillingness to complete all questionnaires and medication diary;
- subjects with secondary causes of parkinsonism;
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 |
|---|---|---|
| Group A - Early ImagingAlso: [123I]-FP-CIT SPECTTotal of 3 scans | Radiation | Group A - Early Imaging |
| Group B - Delayed ImagingAlso: [123I]-FP-CIT SPECTTotal of 2 scans | Radiation | Group B - Delayed Imaging |
Primary outcome
Patient adherence to treatment plan
Time frame: 1 year
Patient and treating physician agree on a treatment plan at visit 3. Patient adherence to medications will be evaluated based on pill count at each follow-up study visit. Additionally, each patient will record their adherence to therapy on the Patient Expectations and Disease-related Questionnaire (PEDQ) at each follow-up study visit, allowing the study team to track compliance with pharmacologic therapy as well as treatments including therapy exercise plans.
5 secondary outcomes
Unified Parkinson Disease Rating Scale (UPDRS)
Time frame: 1 year
Life Orientation Test - Revised (LOT-R)
Time frame: 1 year
Marlowe - Crowne Social Desirability Scale (MCSD)
Time frame: 1 year
Obsessive - Compulsive Inventory (OCI)
Time frame: 1 year
Expectation of Global Response (EGCR)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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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.
Patrick Hickey, DO principal investigator
Duke University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group A - Early Imaging and Group B - Delayed Imaging in people with Parkinson Disease, run by Duke 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 6 inclusion and 9 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 12 Jun 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Patient adherence to treatment plan (time frame: 1 year). 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 12 Jun 2015.