A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients

NCT00402233 | Completed Phase 4 Results

• 2 other identifiers: 248.622PramiBID
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 39

Brief Summary

Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

  Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)

  From baseline to week 12

Secondary Outcomes (3)

• Modified Hoehn and Yahr Stage

  From baseline to week 12

• Epworth Sleepiness Scale

  From baseline to week 12

• Beck Depression Inventory II

  From baseline to week 12

Study Arms (4)

Placebo

OTHER

Drug: Placebo

Pramipexole 0.5 mg Tid

OTHER

Pramipexole 0.5 mg tid (three times a day)

Drug: Pramipexole

Pramipexole 0.5 mg Bid

OTHER

Pramipexole 0.5 mg bid (bis in die (two times a day))

Drug: Pramipexole

Pramipexole 0.75 mg Bid

OTHER

Pramipexole 0.75 mg bid (bis in die (two times a day))

Drug: Pramipexole

Interventions

Pramipexole DRUG

Pramipexole 0.5 mg Bid; Pramipexole 0.5 mg Tid; Pramipexole 0.75 mg Bid

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 31 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be willing and able to give informed consent.
• Must be over 30 years of age at Baseline.
• Must have idiopathic Parkinson's disease of less than 7 years duration since diagnosis, characterized by 2 of the following 3 cardinal signs (signs need to be asymmetric): resting tremor, bradykinesia and rigidity.
• Must have a Modified Hoehn and Yahr stage \<3.
• Should be able to safely tolerate placebo for up to 12 weeks after Baseline.
• Must have a negative urine pregnancy test at the Screening Visit and use an adequate contraceptive method throughout the study if a woman of child-bearing potential. Women who are surgically sterile (hysterectomy or tubal ligation) or whose last menstruation was 12 months or more prior to the Screening Visit are considered to be of non-child-bearing potential. Acceptable forms of contraception include oral, implanted, or injected contraceptives intrauterine devices in place for at least 3 months estrogen patch and adequate barrier methods in conjunction with spermicide. Abstinence is considered an acceptable contraceptive regimen.
• Must be willing and able to comply with trial procedures. They must be sufficiently proficient in English to understand and complete study instruments.

You may not qualify if:

• Individuals with any of the following characteristics will not be eligible for entry into this study:
• Signs or symptoms suggesting other parkinsonian syndromes.
• Use of medications that may cause secondary parkinsonism, including but not limited to: neuroleptics, metaclopramide, alphamethyldopa, flunarizine, methylphenidate, cinnarizine, reserpine, or amphetamines in the last 6 months prior to Baseline Visit.
• Use of dopaminergic medications within the last 3 months or for longer than 6 months prior to Baseline Visit.
• Presence of dementia by Diagnostic and Statistical Manual of Mental Disorders IV criteria (R06-1340) or a Mini Mental State Examination (R96-2656) (Appendix 10.1) score less than 26 at Screening Visit.
• Presence of major depression, as determined by medical history.
• Active epilepsy (i.e., occurrence of a seizure) within the past year prior to Baseline Visit.
• Electro Convulsive Therapy in previous 90 days prior to Baseline Visit.
• Myocardial infarction within previous 6 months prior to Baseline Visit.
• Third degree atrioventricular block or sick sinus syndrome.
• Congestive heart failure Class III or IV by New York Heart Association classification.
• Symptomatic orthostatic hypotension at Screening Visit.
• Stereotaxic brain surgery.
• Clinically significant liver disease.
• Clinically significant renal disease.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (39)

248.622.170 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

248.622.112 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

248.622.69 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Location

248.622.198 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Location

248.622.111 Boehringer Ingelheim Investigational Site

Oxnard, California, United States

Location

248.622.61 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

248.622.23 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

248.622.73 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

248.622.108 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

248.622.190 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Location

248.622.215 Boehringer Ingelheim Investigational Site

Manchester, Connecticut, United States

Location

248.622.196 Boehringer Ingelheim Investigational Site

Boca Raton, Florida, United States

Location

248.622.14 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

248.622.149 Boehringer Ingelheim Investigational Site

Weston, Florida, United States

Location

248.622.139 Boehringer Ingelheim Investigational Site

Honolulu, Hawaii, United States

Location

248.622.5 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

248.622.138 Boehringer Ingelheim Investigational Site

Springfield, Illinois, United States

Location

248.622.87 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

248.622.207 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

248.622.132 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

248.622.17 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

248.622.40 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

248.622.76 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

248.622.186 Boehringer Ingelheim Investigational Site

East Lansing, Michigan, United States

Location

248.622.77 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

248.622.155 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Location

248.622.135 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Location

248.622.216 Boehringer Ingelheim Investigational Site

Kingston, New York, United States

Location

248.622.202 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.622.86 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.622.1 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

248.622.89 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

248.622.20 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

248.622.169 Boehringer Ingelheim Investigational Site

Hershey, Pennsylvania, United States

Location

248.622.18 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

248.622.199 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

248.622.7 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

248.622.213 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

248.622.104 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2006
• First Posted: November 22, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2008
• Last Updated: May 16, 2014
• Results First Posted: January 13, 2010

Record last verified: 2014-05

Locations

US (39)