Trial · NCT00321854

Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

NCT00321854, Phase 4, Completed, Boehringer Ingelheim; results first posted 2010-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD). Trials, record NCT00321854. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00321854

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
NCT number: NCT00321854
Status: Completed
Phases: Phase 4
Enrollment: 535 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Parkinson Disease
Interventions: pramipexole
First posted: 2006-05-04
Last updated: 2014-05-16
Results first posted: 2010-01-26

Source ClinicalTrials.gov

Registered outcomes57

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15	Baseline and Month 15	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Secondary	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15	Baseline and Month 15	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Secondary	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9	Baseline and Month 9	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Secondary	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6	Baseline and Month 6	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Secondary	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3	Baseline and Month 3	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Secondary	Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15	Baseline and Month 15	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Secondary	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15	Baseline and Month 15	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Secondary	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9	Baseline and Month 9	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Secondary	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6	Baseline and Month 6	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Secondary	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3	Baseline and Month 3	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

1 to 10 of 57Source ClinicalTrials.gov

See all 57 registered outcomes

Outcomes57

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15	Baseline and Month 15	The Phase 2 Full Analysis Set (FAS2) was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15	Baseline and Month 15	The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9	Baseline and Month 9	The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6	Baseline and Month 6	The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3	Baseline and Month 3	The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15	Baseline and Month 15	The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15	Baseline and Month 15	The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9	Baseline and Month 9	The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6	Baseline and Month 6	The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3	Baseline and Month 3	The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.	Units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 57Source ClinicalTrials.gov

See all 57 outcomes

Results by group178

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15	Early Pramipexole	0.3	Standard Error 0.7	Units on a scale
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15	Delayed Pramipexole	0.7	Standard Error 0.7	Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15	Early Pramipexole	0.6	Standard Error 0.7	Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15	Delayed Pramipexole	0.5	Standard Error 0.7	Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9	Early Pramipexole	-0.5	Standard Error 0.6	Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9	Delayed Pramipexole	4.3	Standard Error 0.6	Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6	Early Pramipexole	-1.8	Standard Error 0.6	Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6	Delayed Pramipexole	2.6	Standard Error 0.6	Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3	Early Pramipexole	-2.9	Standard Error 0.5	Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3	Delayed Pramipexole	-0.1	Standard Error 0.5	Units on a scale

1 to 10 of 178Source ClinicalTrials.gov

See all 178 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Early Pramipexole	261
Overall Study	STARTED	Delayed Pramipexole	274
Overall Study	COMPLETED	Early Pramipexole	198
Overall Study	COMPLETED	Delayed Pramipexole	192
Overall Study	NOT COMPLETED	Early Pramipexole	63
Overall Study	NOT COMPLETED	Delayed Pramipexole	82

Source ClinicalTrials.gov

Adverse events164

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Early Pramipexole	19	261
other	Nasopharyngitis	Infections and infestations	Delayed Pramipexole	24	274
other	Insomnia	Psychiatric disorders	Early Pramipexole	26	261
other	Insomnia	Psychiatric disorders	Delayed Pramipexole	21	274
other	Depression	Psychiatric disorders	Early Pramipexole	18	261
other	Depression	Psychiatric disorders	Delayed Pramipexole	16	274
other	Sleep disorder	Psychiatric disorders	Early Pramipexole	14	261
other	Sleep disorder	Psychiatric disorders	Delayed Pramipexole	6	274
other	Abnormal dreams	Psychiatric disorders	Early Pramipexole	8	261
other	Abnormal dreams	Psychiatric disorders	Delayed Pramipexole	14	274

1 to 10 of 164Source ClinicalTrials.gov

See all 164 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Early Pramipexole
Total, all-cause mortality	Delayed Pramipexole
Total, other adverse events	Early Pramipexole	172	261
Total, other adverse events	Delayed Pramipexole	164	274
Total, serious adverse events	Early Pramipexole	25	261
Total, serious adverse events	Delayed Pramipexole	25	274

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23726851	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Early Pramipexole vs Delayed Pramipexole: Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15	Trial comparisons
Early Pramipexole vs Delayed Pramipexole: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00321854

GET https://conductscience.org/api/trials/v1/NCT00321854/registered?page=2

API reference For AI assistants