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Clinical Trials/EUCTR2005-003788-22-GB
EUCTR2005-003788-22-GB
Active, not recruiting
Phase 1

A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.

Boehringer Ingelheim Limited0 sites318 target enrollmentNovember 11, 2005
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ConditionsA randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms
DrugsSifrol

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms
Sponsor
Boehringer Ingelheim Limited
Enrollment
318
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 11, 2005
End Date
May 20, 2008
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. 15\-item Geriatric Depression Scale (GDS) \= 5
  • •2\. UPDRS Part I Score on Question \#3 \= 2
  • •3\. Folstein's Mini\-Mental State Examination (MMSE) score \> 24
  • •4\. Male or female patient with idiopathic PD.
  • •5\. Patients with idiopathic PD, Stage I\-III Modified Hoehn and Yahr Scale and optimally controlled PD symptoms in the opinion of the investigator.
  • •6\. Male or female patients aged 30 \- 80 years at time of screening visit.
  • •7\. Ability to provide written informed consent in accordance with GCP and local legislation.
  • •8\. Women of childbearing potential must have a negative serum Beta\-HCG pregnancy test at the Screening visit unless surgically sterile or last menstruation \> 12 months prior to signing IC, or must be using an accepted contraceptive . No exceptions will be made.
  • •9\. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •1\. Previous history of allergic response, lack of efficacy or complications with pramipexole or its excipients.
  • •2\. History of suicidal attempts in the last twelve months.
  • •3\. Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
  • •4\. History of PD stereotactic brain surgery.
  • •5\. History of active epilepsy (i.e. occurrence of a seizure) within the past year.
  • •6\. Symptomatic orthostatic hypotension prior to randomization.
  • •7\. Malignant melanoma or history of previously treated malignant melanoma.
  • •8\. Patients who have received typical neuroleptics, metoclopramide, selegiline or amphetamine derivatives within the past 6 months.
  • •9\. Patients who have received dopamine agonists within the past 30 days
  • •10\. Electroconvulsive therapy during the 90 days preceding the screening visit (V1\).

Outcomes

Primary Outcomes

Not specified

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