Clinical trial NCT00402233: 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
Official title: A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 312
Sex: ALL
Minimum age (years): 31
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

Potential subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study:

1. Must be willing and able to give informed consent.
2. Must be over 30 years of age at Baseline.
3. 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.
4. Must have a Modified Hoehn and Yahr stage \<3.
5. Should be able to safely tolerate placebo for up to 12 weeks after Baseline.
6. 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.
7. Must be willing and able to comply with trial procedures. They must be sufficiently proficient in English to understand and complete study instruments.

Exclusion Criteria:

Individuals with any of the following characteristics will not be eligible for entry into this study:

1. Signs or symptoms suggesting other parkinsonian syndromes.
2. 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.
3. Use of dopaminergic medications within the last 3 months or for longer than 6 months prior to Baseline Visit.
4. 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.
5. Presence of major depression, as determined by medical history.
6. Active epilepsy (i.e., occurrence of a seizure) within the past year prior to Baseline Visit.
7. Electro Convulsive Therapy in previous 90 days prior to Baseline Visit.
8. Myocardial infarction within previous 6 months prior to Baseline Visit.
9. Third degree atrioventricular block or sick sinus syndrome.
10. Congestive heart failure Class III or IV by New York Heart Association classification.
11. Symptomatic orthostatic hypotension at Screening Visit.
12. Stereotaxic brain surgery.
13. Clinically significant liver disease.
14. Clinically significant renal disease.
15. Any other clinically significant medical or psychiatric condition (e.g., angina, active neoplasm) that in the judgment of the investigator would interfere with the subjects ability to participate in the study or would jeopardize safe conduct of the study.
16. Breastfeeding.
17. Known hypersensitivity or intolerability to pramipexole.
18. Participating in other drug studies or receiving other experimental medications within 30 days of Baseline Visit.
19. History of drug or alcohol dependency within 6 months of baseline visit.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
timeFrame: From baseline to week 12
Secondary outcomes:
measure: Modified Hoehn and Yahr Stage
timeFrame: From baseline to week 12
measure: Epworth Sleepiness Scale
timeFrame: From baseline to week 12
measure: Beck Depression Inventory II
timeFrame: From baseline to week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 248.622.170 Boehringer Ingelheim Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: 248.622.112 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: 248.622.69 Boehringer Ingelheim Investigational Site
state: California
city: La Jolla
country: United States
facility: 248.622.198 Boehringer Ingelheim Investigational Site
state: California
city: Oxnard
country: United States
facility: 248.622.111 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 248.622.61 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 248.622.23 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 248.622.73 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 248.622.108 Boehringer Ingelheim Investigational Site
state: Colorado
city: Danbury
country: United States
facility: 248.622.190 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Manchester
country: United States
facility: 248.622.215 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Boca Raton
country: United States
facility: 248.622.196 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 248.622.14 Boehringer Ingelheim Investigational Site
state: Florida
city: Weston
country: United States
facility: 248.622.149 Boehringer Ingelheim Investigational Site
state: Florida
city: Honolulu
country: United States
facility: 248.622.139 Boehringer Ingelheim Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: 248.622.5 Boehringer Ingelheim Investigational Site
state: Illinois
city: Springfield
country: United States
facility: 248.622.138 Boehringer Ingelheim Investigational Site
state: Illinois
city: Louisville
country: United States
facility: 248.622.87 Boehringer Ingelheim Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: 248.622.207 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: 248.622.132 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Boston
country: United States
facility: 248.622.17 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: 248.622.40 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: 248.622.76 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: East Lansing
country: United States
facility: 248.622.186 Boehringer Ingelheim Investigational Site
state: Michigan
city: Omaha
country: United States
facility: 248.622.77 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Lebanon
country: United States
facility: 248.622.155 Boehringer Ingelheim Investigational Site
state: New Hampshire
city: Brooklyn
country: United States
facility: 248.622.135 Boehringer Ingelheim Investigational Site
state: New York
city: Kingston
country: United States
facility: 248.622.216 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 248.622.202 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 248.622.86 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 248.622.1 Boehringer Ingelheim Investigational Site
state: New York
city: Cincinnati
country: United States
facility: 248.622.89 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 248.622.20 Boehringer Ingelheim Investigational Site
state: Ohio
city: Hershey
country: United States
facility: 248.622.169 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: 248.622.18 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: 248.622.199 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 248.622.7 Boehringer Ingelheim Investigational Site
state: Texas
city: Spokane
country: United States
facility: 248.622.213 Boehringer Ingelheim Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: 248.622.104 Boehringer Ingelheim Investigational Site
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: