Parkinson DiseasePhase 4NCT00402233

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

A Phase 4 study testing Pramipexole in people with Parkinson Disease, run by Boehringer Ingelheim at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 31 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Pramipexole
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 312 participants
Where: 39 sitesUnited States
Study dates: Nov 2006to Sep 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 31 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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.
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.
Breastfeeding.
Known hypersensitivity or intolerability to pramipexole.
Participating in other drug studies or receiving other experimental medications within 30 days of Baseline Visit.
History of drug or alcohol dependency within 6 months of baseline visit.

Trial locations and contacts

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

United States39 sites

248.622.196 Boehringer Ingelheim Investigational Site
Boca Raton, Florida
248.622.17 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
248.622.40 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
248.622.76 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
248.622.135 Boehringer Ingelheim Investigational Site
Brooklyn, New York
248.622.5 Boehringer Ingelheim Investigational Site
Chicago, Illinois
248.622.89 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
248.622.20 Boehringer Ingelheim Investigational Site
Columbus, Ohio
248.622.190 Boehringer Ingelheim Investigational Site
Danbury, Connecticut
248.622.108 Boehringer Ingelheim Investigational Site
Denver, Colorado
248.622.186 Boehringer Ingelheim Investigational Site
East Lansing, Michigan
248.622.69 Boehringer Ingelheim Investigational Site
Fountain Valley, California
248.622.169 Boehringer Ingelheim Investigational Site
Hershey, Pennsylvania
248.622.139 Boehringer Ingelheim Investigational Site
Honolulu, Hawaii
248.622.199 Boehringer Ingelheim Investigational Site
Houston, Texas
248.622.7 Boehringer Ingelheim Investigational Site
Houston, Texas
248.622.216 Boehringer Ingelheim Investigational Site
Kingston, New York
248.622.198 Boehringer Ingelheim Investigational Site
La Jolla, California
248.622.155 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire
248.622.112 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
248.622.87 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
248.622.215 Boehringer Ingelheim Investigational Site
Manchester, Connecticut
248.622.14 Boehringer Ingelheim Investigational Site
Miami, Florida
248.622.104 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
248.622.207 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
248.622.202 Boehringer Ingelheim Investigational Site
New York, New York
248.622.86 Boehringer Ingelheim Investigational Site
New York, New York
248.622.77 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
248.622.111 Boehringer Ingelheim Investigational Site
Oxnard, California
248.622.18 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
248.622.170 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
248.622.1 Boehringer Ingelheim Investigational Site
Rochester, New York
248.622.61 Boehringer Ingelheim Investigational Site
Sacramento, California
248.622.23 Boehringer Ingelheim Investigational Site
San Diego, California
248.622.73 Boehringer Ingelheim Investigational Site
San Francisco, California
248.622.132 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
248.622.213 Boehringer Ingelheim Investigational Site
Spokane, Washington
248.622.138 Boehringer Ingelheim Investigational Site
Springfield, Illinois
248.622.149 Boehringer Ingelheim Investigational Site
Weston, Florida

Other trials in United States

About this study

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)

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
Being tested: Pramipexole, Placebo
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PramipexoleDrug
PlaceboDrug

Study groups in NCT00402233
Study group	Role	What they receive
Placebo	Other	Not described Receives: Drug: Placebo
Pramipexole 0.5 mg Tid	Other	Pramipexole 0.5 mg tid (three times a day) Receives: Drug: Pramipexole
Pramipexole 0.5 mg Bid	Other	Pramipexole 0.5 mg bid (bis in die (two times a day)) Receives: Drug: Pramipexole
Pramipexole 0.75 mg Bid	Other	Pramipexole 0.75 mg bid (bis in die (two times a day)) Receives: Drug: Pramipexole

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: From baseline to week 12

Secondary outcomes (3)

Modified Hoehn and Yahr Stage
Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)
Measured: From baseline to week 12
Epworth Sleepiness Scale
Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)
Measured: From baseline to week 12
Beck Depression Inventory II
Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)
Measured: From baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Sep 2008

First posted22 Nov 2006 (estimated)
Study startNov 2006
Primary completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00402233
Sponsor's protocol ID: 248.622
Other IDs: PramiBID
Status last verified: May 2014
First submitted: 19 Nov 2006
Last updated: 16 May 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00402233
Acronym / sponsor ID: 248.622
Conditions: Parkinson Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Sep 2008 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Posted 13 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Other	Drug: Placebo
Pramipexole 0.5 mg Tid	Other	Drug: PramipexolePramipexole 0.5 mg tid (three times a day)
Pramipexole 0.5 mg Bid	Other	Drug: PramipexolePramipexole 0.5 mg bid (bis in die (two times a day))
Pramipexole 0.75 mg Bid	Other	Drug: PramipexolePramipexole 0.75 mg bid (bis in die (two times a day))

Who may qualify

Ages: 31 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pramipexole	Drug	Pramipexole 0.5 mg Bid, Pramipexole 0.5 mg Tid, Pramipexole 0.75 mg Bid
Placebo	Drug	Placebo

Primary outcome

Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Time frame: From baseline to week 12
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)

3 secondary outcomes

Modified Hoehn and Yahr Stage
Time frame: From baseline to week 12
Epworth Sleepiness Scale
Time frame: From baseline to week 12
Beck Depression Inventory II
Time frame: From baseline to week 12

Results and safety

Results posted to the registry on 13 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	77	72
Mirapex (Pramipexole 0.5 mg Tid)	80	70
Mirapex (Pramipexole 0.5 mg Bid)	81	70
Mirapex (Pramipexole 0.75 mg Bid)	73	62

Primary outcome: Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

Time frame: From baseline to week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 77	Mirapex (Pramipexole 0.5 mg Tid) n = 80	Mirapex (Pramipexole 0.5 mg Bid) n = 81	Mirapex (Pramipexole 0.75 mg Bid) n = 73
UPDRS at baseline	28.97 (11.82)	27.66 (10.72)	27.21 (11.76)	27.77 (9.18)
UPDRS at week 12	28.19 (12.94)	22.92 (10.44)	22.96 (11.94)	22.65 (10.82)

Placebo vs Mirapex (Pramipexole 0.5 mg Tid): Mean Difference (Final Values): -4.4 (95% CI -6.53 to -2.26), p <0.0001, ANCOVA
Placebo vs Mirapex (Pramipexole 0.5 mg Bid): Mean Difference (Final Values): -4.41 (95% CI -6.54 to -2.28), p <0.0001, ANCOVA
Placebo vs Mirapex (Pramipexole 0.75 mg Bid): Mean Difference (Final Values): -4.72 (95% CI -6.91 to -2.52), p <0.0001, ANCOVA

Population analysed: Treated set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 77 (0%)	27 of 77 (35.1%)	Not reported
Mirapex (Pramipexole 0.5 mg Bid)	0 of 81 (0%)	42 of 81 (51.9%)	Not reported
Mirapex (Pramipexole 0.75 mg Bid)	2 of 73 (2.7%)	37 of 73 (50.7%)	Not reported
Mirapex (Pramipexole 0.5 mg Tid)	1 of 80 (1.3%)	43 of 80 (53.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

39 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pramipexole in people with Parkinson Disease, run by Boehringer Ingelheim at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (time frame: From baseline to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.