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Pilot Study To Assess Effect of Treatment and Adherence in PD Subjects

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Group A - Early Imaging
Group B - Delayed Imaging
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Parkinsonism, Idiopathic Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Sites / Locations

  • Duke University Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A - Early Imaging

Group B - Delayed Imaging

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Unified Parkinson Disease Rating Scale (UPDRS)
Other outcome measures will be between any group differences in UPDRS.
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.
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.
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.
Expectation of Global Response (EGCR)
Other outcome measures will be between any group differences in EGCR.

Full Information

First Posted
February 7, 2013
Last Updated
June 11, 2015
Sponsor
Duke University
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01788696
Brief Title
Pilot Study To Assess Effect of Treatment and Adherence in PD Subjects
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
GE Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed Description
The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as DaTscan. DaTscan is FDA approved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinsonism, Idiopathic Parkinson Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - Early Imaging
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B - Delayed Imaging
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Group A - Early Imaging
Other Intervention Name(s)
[123I]-FP-CIT SPECT
Intervention Description
Total of 3 scans
Intervention Type
Radiation
Intervention Name(s)
Group B - Delayed Imaging
Other Intervention Name(s)
[123I]-FP-CIT SPECT
Intervention Description
Total of 2 scans
Primary Outcome Measure Information:
Title
Patient adherence to treatment plan
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Unified Parkinson Disease Rating Scale (UPDRS)
Description
Other outcome measures will be between any group differences in UPDRS.
Time Frame
1 year
Title
Life Orientation Test - Revised (LOT-R)
Description
Other outcome measures will be between any group differences in LOT-R. This test assesses individual differences in generalized optimism versus pessimism.
Time Frame
1 year
Title
Marlowe - Crowne Social Desirability Scale (MCSD)
Description
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.
Time Frame
1 year
Title
Obsessive - Compulsive Inventory (OCI)
Description
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.
Time Frame
1 year
Title
Expectation of Global Response (EGCR)
Description
Other outcome measures will be between any group differences in EGCR.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Hickey, DO
Organizational Affiliation
Duke University Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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Pilot Study To Assess Effect of Treatment and Adherence in PD Subjects

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