Safety and Efficacy of Pramipexole and Bromocriptine Comb... | NCT02172573

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

NCT02172573

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jun 24, 2014Estimated

Enrollment

315Actual

Phase

Phase 3

Conditions

Parkinson Disease

Interventions

Pramipexole
Bromocriptine
Placebo pramipexole
Placebo bromocriptine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1999

Primary Completion Date

Jul 2000Actual

Completion Date

Not provided

First Submitted Date

Jun 20, 2014

First Submission Date that Met QC Criteria

Jun 20, 2014

First Posted Date

Jun 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2014

Last Update Posted Date

Jun 24, 2014Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

315Actual

Label	Type	Intervention Names
Pramipexole	Experimental	Drug: Pramipexole
Bromocriptine	Experimental	Drug: Bromocriptine
Placebo	Placebo Comparator	Drug: Placebo pramipexole Drug: Placebo bromocriptine

Name	Type	Description	Arm Group Labels	Other Names
Pramipexole	Drug		Pramipexole
Bromocriptine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Change from baseline in total score of UPDRS Part III (Motor Examination)		Baseline and week 12

Secondary Outcomes

Measure	Description	Time Frame
Changes from baseline in sores of individual items on UPDRS Part II		Baseline and weeks 2, 4, 6, 8, 10, 12
Changes from baseline in scores of individual items on UPDRS Part III		Baseline and weeks 2, 4, 6, 8, 10, 12

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D052160	Benzothiazoles
D013844	Thiazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring