Expired Study
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Portland, Oregon 97239


Purpose:

The purpose of this study is to determine whether there is a benefit to giving a dopamine agonist to a patient with Parkinson's disease who is already being treated with levodopa.


Study summary:

Patients with idiopathic PD based on London Brain Bank criteria as determined by an OHSU movement disorder specialist entered the study. They gave informed consent to a protocol approved by the Oregon Health and Science University Institutional Review Board and General Clinical Research Center (GCRC) Review Committee. Patients were on long-term levodopa therapy, and had motor fluctuations and dyskinesia as determined during screening. Subjects were screened with finger tapping (FT) in the practically defined OFF motor state, having been off LD overnight, and in the practically defined ON motor state. To qualify, they had to have a minimum 10% improvement in the ON state. The trial was a randomized, double-blind, placebo-controlled crossover study with subjects on pramipexole for 4 weeks and an identically appearing placebo for 4 weeks. The response to two-hour LD infusions at 0.5 (threshold) and 1.0 (suprathreshold) mg/kg/hr were examined at the end of each 4 week treatment period. The primary outcome was finger-tapping speed, as a surrogate marker of bradykinesia, over a seven hour time period. The area under the curve (AUC) was calculated as finger taps x minutes (FTM). Secondary outcomes measured included peak motor response, as measured by FT, walking speed, dyskinesia, time-to-ON (defined as a 10% increase in finger tapping speed over the baseline), and effects of LD infusion on subjects' perceived mood, anxiety and fatigue. Subjects were randomized to receive either pramipexole (PPX) or placebo for the initial 5 weeks of the study. The PPX and placebo was titrated up over 9 days to a target dose of 1.0mg TID. If they were already taking a DA, this was tapered and discontinued while the study medication was titrated upward. Their LD was continued according to the subjects normal schedule during this time period, as well as any other antiparkinsonian medications they were taking. After a maintenance phase of 4 weeks on study medication (PPX 1.0mg TID or placebo TID) subjects were admitted in the evening to the inpatient GCRC at OHSU. Their last LD dose was given no later than 10 pm and all other PD medications were withheld after 10 pm. They practiced FT sessions on the night of admission. At 7 AM the next morning, a dose of the study drug was given and an IV line was placed. An IV levodopa infusion was administered starting at 9 am, continuously over 2 hours at a rate of either 0.5mg/kg/hr or 1.0 mg/kg/hr. The infusion rate was blinded and randomized. The infusion was stopped at 11 am. After 2:00 PM and when subjects were deemed "off", the usual antiparkinson medications were reinstituted. FT, tremor, walking (timed and # of steps), dyskinesia, and a "global" PD scale were measured by research nurses, and subjects completed visual analogue scales (VASs) for anxiety, fatigue and mood every 30 minutes from 7:00 AM until 2:00 PM.


Criteria:

Inclusion Criteria: - Age 30-80 - Idiopathic PD Hoehn & Yahr stage 2-4, - diagnosed by 2 of the 3 cardinal motor features - Fluctuation response to levodopa - Dyskinesia - No other historical, laboratory or physical signs to suggest an alternate diagnosis - No significant dementia, MMSE>24 - On oral levodopa therapy Exclusion Criteria: - dementia - psychosis - severe anxiety - unstable cardiovascular disease - uncontrolled hypertension - history of cardiac arrhythmias - active peptic ulcer disease - anemia (HCT<32%)


Study is Available At:


Original ID:

697


NCT ID:

NCT00666653


Secondary ID:


Study Acronym:

DALI


Brief Title:

Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease


Official Title:

Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease: a Double-Blind Placebo Controlled Crossover Study


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

30 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Oregon Health and Science University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

13


Enrollment Type:

Actual


Overall Contact Information

Official Name:Matthew A Brodsky, MD
Principal Investigator
Oregon Health and Science University

Study Dates

Start Date:July 2003
Completion Date:May 2007
Completion Type:Actual
Primary Completion Date:May 2007
Primary Completion Type:Actual
Verification Date:April 2008
Last Changed Date:April 24, 2008
First Received Date:April 23, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Gait performance
Time Frame:2 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Dyskinesia rating score
Time Frame:2 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Area Under the Curve of motor function based on finger tapping scores
Time Frame:2 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:pramipexole

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Oregon Health and Science University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Boehringer Ingelheim Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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