Status:
COMPLETED
Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Parkinson Disease
Depression
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells)...
Eligibility Criteria
Inclusion
- 15-item Geriatric Depression Scale (GDS) \> or = 5
- Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score on Question #3 \> or = 2
- Folsteins Mini-Mental State Examination (MMSE) score \> 24
- Male or female patient with PD (UK PD Brain Bank criteria).
- Patients diagnosed with idiopathic PD, Stage I-III by the Modified Hoehn and Yahr Scale and optimally controlled PD symptoms .
- Male or female patients aged 30 - 80 years.
- Ability to provide written informed consent.
- Women of childbearing potential must have a negative serum beta-humanchoriongonadotropin (Beta-HCG) pregnancy test at the Screening visit unless surgically sterile or last menstruation \>or = 12 months prior to signing informed consent.
- Women of childbearing potential must be using an accepted contraceptive.
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion
- Previous history of allergic response, lack of efficacy or complications with pramipexole or its excipients.
- History of suicidal attempts in the last twelve months; presence of suicidal tendencies/potential.
- Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- History of PD stereotactic brain surgery.
- Surgery within 180 days of randomization that would negatively impact the patients participation in the study.
- History of active epilepsy within the past year.
- Current psychotherapy or behavior therapy while participating the trial
- Symptomatic orthostatic hypotension prior to randomization.
- Malignant melanoma or history of previously treated malignant melanoma.
- Patients who have received typical neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, selegiline or amphetamine derivatives within the past 3 months.
- Patients who have received dopamine agonists within the past 30 days
- Electroconvulsive therapy during the 90 days preceding the screening visit (Visit 1).
- Patients who are currently lactating.
- Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization.
- Any other laboratory assay abnormality, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient
- Any other clinically significant medical/psychiatric condition, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT00297778
Start Date
March 1 2006
Last Update
June 9 2014
Active Locations (77)
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1
248.596.43003 Boehringer Ingelheim Investigational Site
Graz, Austria
2
248.596.43001 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
3
248.596.43005 Boehringer Ingelheim Investigational Site
Linz, Austria
4
248.596.43004 Boehringer Ingelheim Investigational Site
Sankt Pölten, Austria