NCT00560508

Brief Summary

The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_2 parkinson-disease

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 10, 2011

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

November 16, 2007

Results QC Date

November 25, 2010

Last Update Submit

July 29, 2014

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Experienced Adverse Events

    An adverse event is defined as any untoward medical occurrence

    12 weeks

Secondary Outcomes (32)

  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score

    baseline and after 12 weeks treatment

  • Change From Baseline in Percentage Off-time

    baseline and after 12 weeks treatment

  • Change From Baseline in Percentage On-time Without Dyskinesia

    baseline and after 12 weeks treatment

  • Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia

    baseline and after 12 weeks treatment

  • Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia

    baseline and after 12 weeks treatment

  • +27 more secondary outcomes

Study Arms (2)

Pramipexole Extended Release

EXPERIMENTAL

patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -\> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID

Drug: Pramipexole Extended Release

Pramipexole Immediate Release

ACTIVE COMPARATOR

patient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -\> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID

Drug: Pramipexole Immediate Release

Interventions

Pramipexole Immediate ReleaseDRUG

titrated as individually needed (0.25 mg - 4.5 mg daily)

Pramipexole Immediate Release
Pramipexole Extended ReleaseDRUG

titration as individually needed (0.375 mg -4.5 mg daily)

Pramipexole Extended Release

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients with diagnosis of PD including juvenile Parkinsonism, in whom the onset began at the age of forty or younger.
  • Patients with a modified Hoehn and Yahr scale of II to IV at "on" time.
  • Patients who have received an individual dosage of L-DOPA (either standard L-DOPA or L-DOPA with dopa-decarboxylase inhibitor) at a stable dose for at least 4 weeks before the baseline visit (Visit 2).
  • Patients who exhibit any therapeutically problematic issues or status based on L-DOPA therapy:
  • wearing-off phenomena
  • no on /delayed on
  • dystonia at off time
  • on-off phenomena
  • freezing phenomena at off time
  • the sub-optimal dose of L-DOPA had been administered due to side effects (such as dyskinesia), or therapeutical strategy

You may not qualify if:

  • Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
  • Dementia, as defined by a Mini-Mental State Examination (MMSE) score \<24 at screening visit.
  • Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the trial and/or put the patient at risk if he/she takes part in the trial.
  • History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation in the trial would not represent a significant risk for the patient).
  • Clinically significant ECG abnormalities at screening visit, according to investigator's judgement.
  • Clinically significant hypotension or symptomatic orthostatic hypotension (i.e., clinical symptoms of orthostatic hypotension such as dizziness postural etc associated with a decline \>=20 mmHg in systolic blood pressure and a decline \>=10 mmHg in diastolic blood pressure, at one minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest) either at screening visit or at baseline visit.
  • Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the trial.
  • Pregnancy (to be excluded by serum pregnancy test at screening visit) or breast-feeding.
  • Sexually active female of childbearing potential not using a medically approved method of birth control within one month before to the screening visit and throughout the trial period.
  • Serum levels of AST, ALT, alkaline phosphatases or bilirubin \>2 upper limits of normal .
  • Patients with a creatinine clearance \<50 mL/min
  • Patients with a complication or signs of malignant tumours or those within 5 years after the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

248.610.019 Boehringer Ingelheim Investigational Site

Akashi, Hyogo, Japan

Location

248.610.020 Boehringer Ingelheim Investigational Site

Akita, Akita, Japan

Location

248.610.006 Boehringer Ingelheim Investigational Site

Aomori, Aomori, Japan

Location

248.610.017 Boehringer Ingelheim Investigational Site

Asahikawa, Hokkaido, Japan

Location

248.610.018 Boehringer Ingelheim Investigational Site

Asahikawa, Hokkaido, Japan

Location

248.610.001 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

248.610.014 Boehringer Ingelheim Investigational Site

Fuchu, Tokyo, Japan

Location

248.610.011 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

248.610.015 Boehringer Ingelheim Investigational Site

Iwamizawa,Hokkaido, Japan

Location

248.610.003 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, Japan

Location

248.610.008 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

248.610.021 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

248.610.010 Boehringer Ingelheim Investigational Site

Morioka, Iwate, Japan

Location

248.610.005 Boehringer Ingelheim Investigational Site

Okayama, Okayama, Japan

Location

248.610.012 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

248.610.004 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, Japan

Location

248.610.009 Boehringer Ingelheim Investigational Site

Shimogyo-ku, Kyoto, Kyoto, Japan

Location

248.610.007 Boehringer Ingelheim Investigational Site

Shiroishi, Miyagi, Japan

Location

248.610.002 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

November 1, 2007

Primary Completion

November 1, 2009

Last Updated

July 31, 2014

Results First Posted

February 10, 2011

Record last verified: 2014-07

Locations

JP(19)