Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients

NCT00144300 | Completed Phase 4 Results

• 1 other identifier: 248.538
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 21

Brief Summary

To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Expert Panel Overall Assessment Following 2 Years on Drug

  Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments

  up to 2 years

Secondary Outcomes (20)

• Expert Panel Overall Assessment Following 1 Year on Drug

  up to 1 years

• Hoehn and Yahr Scale at Baseline

  Baseline

• Hoehn and Yahr Scale at 1 Year

  Up to 1 year

• Hoehn and Yahr Scale at 2 Years

  Up to 2 years

• Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline

  Baseline

Study Arms (2)

Mirapex

ACTIVE COMPARATOR

Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines

Drug: Mirapex

Requip

ACTIVE COMPARATOR

Requip tablets three times daily (TID) dosing according to manufacturer's guidelines

Drug: Requip

Interventions

Mirapex DRUG

Standard marketed product dispensed according to manufacturer's guidelines

Mirapex

Requip DRUG

Standard marketed product dispensed according to manufacturer's guidelines

Requip

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with idiopathic Parkinson's disease of less than 7 years characterized as Stage I-III by the Modified Hoehn and Yahr Scale and with a maximum of 6 months cumulative lifetime exposure to levodopa and/or dopamine agonist. Patients on current dopamine agonist therapy would require 14-day washout.
• Age at least 30 years.
• Women of childbearing potential must have a negative serum beta-HCG pregnancy test at the Screen (Baseline) visit and the patient must use adequate contraceptive methods.
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
• Patients who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.

You may not qualify if:

• Previous history of allergic response or complications with any dopaminergic agonist drug
• Atypical PD syndromes
• History of stereotactic brain surgery
• Positive hepatitis B (surface antigen) or hepatitis C (antibody)
• Surgery within 180 days of randomization which would negatively impact participation
• Folstein's Mini Mental State Examination (MMSE) score of 24 or less
• History of active epilepsy (seizure) in the past 1 year
• Third degree AV block or sick sinus syndrome
• Congestive heart failure, Class III or IV
• Unstable heart disease such as unstable angina, dysrhythmia, or myocardial infarction in prior 6 months
• Symptomatic orthostatic hypotension
• Clinically significant liver disease or renal disease
• Malignant melanoma or history of previously treated malignant melanoma.
• Prohibited medications taken (including any drug known to have potential retino-toxic effects taken in the prior 12 months; neuroleptics taken within prior 6 months, MAO inhibitors except rasagiline or selegiline taken within prior 3 months, beta-blockers taken to treat Parkinson's disease in the prior 30 days, and Coenzyme Q10 taken within 14 days)
• Albinism/Albinoidism of any degree, type or syndrome

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (21)

248.538.00007 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

248.538.00008 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

248.538.00021 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Location

248.538.00022 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

248.538.00001 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

Location

248.538.00002 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

248.538.00016 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

248.538.00023 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

248.538.00013 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

248.538.00009 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Location

248.538.00011 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

248.538.00005 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

248.538.00014 Boehringer Ingelheim Investigational Site

Southfield, Michigan, United States

Location

248.538.00010 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.538.00015 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.538.00020 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.538.00012 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

248.538.00006 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

248.538.00004 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

248.538.00003 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

248.538.00017 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Location

Related Publications (1)

• Seiple W, Jennings D, Rosen RB, Borchert L, Canale L, Fagan N, Gordon MF. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease. Parkinsons Dis. 2016;2016:8298503. doi: 10.1155/2016/8298503. Epub 2016 Dec 18.

  PMID: 28078162 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole; ropinirole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: January 1, 2005
• Primary Completion: September 1, 2010
• Last Updated: March 14, 2014
• Results First Posted: November 4, 2011

Record last verified: 2014-02

Locations

US (21)