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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02172573
• Collaborator: (none)
• Enrollment: 315
• Arms: 3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Apr 1, 1999
• Actual Primary Completion Date: Jul 1, 2000

Arms and Interventions

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

Outcome Measures

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) [Baseline and week 12]

2. Change from baseline in total score of UPDRS Part III (Motor Examination) [Baseline and week 12]

Secondary Outcome Measures

1. Changes from baseline in sores of individual items on UPDRS Part II [Baseline and weeks 2, 4, 6, 8, 10, 12]

2. Changes from baseline in scores of individual items on UPDRS Part III [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 [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 [Baseline and weeks 2, 4, 6, 8, 10, 12]

5. Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood) [Baseline and weeks 2, 4, 6, 8, 10, 12]

6. Change from baseline in total score of UPDRS Part IV (complications of therapy) [Baseline and weeks 2, 4, 6, 8, 10, 12]

7. Change from baseline in total score of UPDRS Part I-III [Baseline and weeks 2, 4, 6, 8, 10, 12]

8. Change from baseline in total score of UPDRS Part I-IV [Baseline and weeks 2, 4, 6, 8, 10, 12]

9. Change from baseline in Modified Hoehn & Yahr stage [Baseline and weeks 2, 4, 6, 8, 10, 12]

10. Clinical global impression of efficacy [week 12]

11. Number of patients with adverse events [up to 16 weeks]

12. Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate) [up to 12 weeks]

13. Number of patients with abnormal changes in laboratory parameters [up to 12 weeks]

14. Number of patients with abnormal changes in 12-lead electrocardiogram (ECG) [up to 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02172573
• Other Study ID Numbers: 248.505
• First Posted: Jun 24, 2014
• Last Update Posted: Jun 24, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Parkinson Disease; Pramipexole; Bromocriptine

Study Results

No Results Posted as of Jun 24, 2014