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Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02172573
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease using placebo and bromocriptine tablets as comparators in a double-blind design (phase III comparative study).

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Pramipexole Drug: Bromocriptine Drug: Placebo pramipexole Drug: Placebo bromocriptine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's Disease
Study Start Date : April 1999
Actual Primary Completion Date : July 2000


Arm Intervention/treatment
Experimental: Pramipexole Drug: Pramipexole
Experimental: Bromocriptine Drug: Bromocriptine
Placebo Comparator: Placebo Drug: Placebo pramipexole
Drug: Placebo bromocriptine



Primary Outcome Measures :
  1. Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) [ Time Frame: Baseline and week 12 ]
  2. Change from baseline in total score of UPDRS Part III (Motor Examination) [ Time Frame: Baseline and week 12 ]

Secondary Outcome Measures :
  1. Changes from baseline in sores of individual items on UPDRS Part II [ Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12 ]
  2. Changes from baseline in scores of individual items on UPDRS Part III [ Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12 ]
  3. Change from baseline in area under the curve (AUC) in the UPDRS Part II score [ Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12 ]
  4. Change from baseline in area under the curve (AUC) in the UPDRS Part III score [ Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12 ]
  5. Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood) [ Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12 ]
  6. Change from baseline in total score of UPDRS Part IV (complications of therapy) [ Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12 ]
  7. Change from baseline in total score of UPDRS Part I-III [ Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12 ]
  8. Change from baseline in total score of UPDRS Part I-IV [ Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12 ]
  9. Change from baseline in Modified Hoehn & Yahr stage [ Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12 ]
  10. Clinical global impression of efficacy [ Time Frame: week 12 ]
  11. Number of patients with adverse events [ Time Frame: up to 16 weeks ]
  12. Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate) [ Time Frame: up to 12 weeks ]
  13. Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to 12 weeks ]
  14. Number of patients with abnormal changes in 12-lead electrocardiogram (ECG) [ Time Frame: up to 12 weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)
  • Patients who meet all of the following inclusion criteria

    • Patients who were at least 20 years of age
    • In- or outpatients of either sex
    • Patients in any stage on the modified Hoehn and Yahr scale
  • Patients being treated with L-dopa who have any of the following clinical conditions and problems

    • Patients with the wearing-off phenomenon
    • Patients with the on-off phenomenon
    • Patients to whom a sufficient amount of L-dopa cannot be administered owing to the occurrence of an adverse event
    • Patients in whom the effect of L-dopa is attenuated
    • Patients in whom a dose increase of L-dopa has been refrained
    • Patients with freezing phenomenon

Exclusion Criteria:

  • Patients being treated with other dopamine agonists (bromocriptine, pergolide mesylate, talipexole hydrochloride). Patients who have been treated with other dopamine agonist for at least 4 weeks before the start of the study (the day of giving informed consent) are eligible for the study
  • Patients with a history of hypersensitivity to ergot preparations
  • Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour
  • Patients with subjective symptoms derived from orthostatic hypotension
  • Patients with hypotension (systolic blood pressure less than 100 mmHg)
  • Patients wiht Raynaud disease
  • Patients with peptic ulcer
  • Patients with complications such as severe cardiac, renal, hepatic disease etc.
  • Patients with a current or past history of epilepsy
  • Women who are or may be pregnant and lactating women
  • Patients who are receiving any other investigational products or who have received any other investigational product within 6 months of the study
  • Patients who are incompetent to give consent
  • Others judged by the investigator or co-investigator to be ineligible as subjects
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172573    
Other Study ID Numbers: 248.505
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Pramipexole
Bromocriptine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists