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.

• Register: EUCTR
• Last refreshed on: 3 June 2013
• Main ID: EUCTR2005-003788-22-AT
• Date of registration: 18/01/2006
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim Austria GmbH
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 22/02/2006
• Target sample size: 318
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003788-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Finland, Germany, Italy, Spain, Sweden, United Kingdom

Key inclusion & exclusion 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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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).
11. Patients who are currently lactating.
12. Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization.
13. Any other laboratory assay abnormality and/or clinically significant medical/psychiatric condition, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient according to the investigator



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Trade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,088-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,18-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,35-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,7-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To investigate the efficacy of pramipexole, compared with placebo in treating Parkinson’s disease patients with stable motor function and depressive symptoms. The efficacy of pramipexole vs. placebo will be based on the Beck Depression Inventory (BDI) total score.

Secondary Objective: To assess further depression response (% patients with 50% reduction from baseline in total BDI score, GDS total score, and UPDRS part I), motor function (standard version UPDRS part II & III), complications of therapy (UPDRS part IV), anhedonia (SHAPS), quality of life (PDQ-39 and EQ-5D), Clinical Global Improvement (CGI-I) and pain (VAS)

Primary end point(s): The primary endpoint for this study is clinical response after 12 weeks of treatment, defined as a change in total score of baseline symptoms as measured by the BDI total score.

Secondary ID(s)

2005-003788-22-GB

248.596