Trial · NCT00472199

Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)

NCT00472199, Phase 4, Completed, Boehringer Ingelheim; results first posted 2009-11-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS). Trials, record NCT00472199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00472199

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Trial

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

Title: Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
NCT number: NCT00472199
Status: Completed
Phases: Phase 4
Enrollment: 331 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Restless Legs Syndrome
Interventions: Pramipexole, Placebo
First posted: 2007-05-11
Last updated: 2014-06-27
Other registries' IDs: eudract:2006-006431-42
Results first posted: 2009-11-17

Source ClinicalTrials.gov

Registered outcomes31

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks	Baseline and 26 weeks	IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)
Secondary	Clinical Global Impression - Global Improvement (CGI-I) Responder Rate	after 26 weeks of treatment	CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring 1 or 2 (at least much improved)
Secondary	International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate	after 26 weeks of treatment	IRLS response was defined as at least 50% reduction in IRLS total score from baseline. IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe symptoms)
Secondary	Patient Global Impression (PGI) Responder Rate	after 26 weeks of treatment	PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)
Secondary	Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks	baseline and 26 weeks of treatment	The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Secondary	Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks	Baseline and 26 weeks of treatment	The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Secondary	Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks	baseline and 26 weeks of treatment	The question was rated on an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Secondary	Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks	Baseline and 26 weeks of treatment	The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Secondary	Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks	Baseline and 26 weeks of treatment	The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Secondary	Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks	Baseline and 26 weeks of treatment	The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week

1 to 10 of 31Source ClinicalTrials.gov

See all 31 registered outcomes

Outcomes31

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 International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks	Baseline and 26 weeks	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression - Global Improvement (CGI-I) Responder Rate	after 26 weeks of treatment	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values.	participants	NUMBER
SECONDARY	International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate	after 26 weeks of treatment	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values	participants	NUMBER
SECONDARY	Patient Global Impression (PGI) Responder Rate	after 26 weeks of treatment	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values	participants	NUMBER
SECONDARY	Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score Satisfaction With Sleep After 26 Weeks	baseline and 26 weeks of treatment	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values	Scores on a scale	MEDIAN
SECONDARY	Change From Baseline in RLS-6 Score Severity Falling Asleep After 26 Weeks	Baseline and 26 weeks of treatment	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values	Scores on a scale	MEDIAN
SECONDARY	Change From Baseline in RLS-6 Score Severity During the Night After 26 Weeks	baseline and 26 weeks of treatment	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values	Scores on a scale	MEDIAN
SECONDARY	Change From Baseline in RLS-6 Score Severity During the Day When at Rest After 26 Weeks	Baseline and 26 weeks of treatment	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values	Scores on a scale	MEDIAN
SECONDARY	Change From Baseline RLS-6 Score Severity During the Day Engaged in Activities After 26 Weeks	Baseline and 26 weeks of treatment	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values	Scores on a scale	MEDIAN
SECONDARY	Change From Baseline in RLS-6 Score Tired or Sleepy During the Day After 26 Weeks	Baseline and 26 weeks of treatment	Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values	Scores on a scale	MEDIAN

1 to 10 of 31Source ClinicalTrials.gov

See all 31 outcomes

Results by group80

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks	Pramipexole		-13.7	Standard Error 0.8	Scores on a scale
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks	Placebo		-11.1	Standard Error 0.8	Scores on a scale
Clinical Global Impression - Global Improvement (CGI-I) Responder Rate	Pramipexole	CGI-I responder (at least much improved)	111		participants
Clinical Global Impression - Global Improvement (CGI-I) Responder Rate	Placebo	CGI-I responder (at least much improved)	80		participants
Clinical Global Impression - Global Improvement (CGI-I) Responder Rate	Pramipexole	CGI-I non-responder	51		participants
Clinical Global Impression - Global Improvement (CGI-I) Responder Rate	Placebo	CGI-I non-responder	79		participants
International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate	Pramipexole	IRLS responder	95		participants
International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate	Placebo	IRLS responder	68		participants
International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate	Pramipexole	IRLS non-responder	67		participants
International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate	Placebo	IRLS non-responder	91		participants

1 to 10 of 80Source ClinicalTrials.gov

See all 80 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pramipexole	166
Overall Study	STARTED	Placebo	163
Overall Study	COMPLETED	Pramipexole	131
Overall Study	COMPLETED	Placebo	103
Overall Study	NOT COMPLETED	Pramipexole	35
Overall Study	NOT COMPLETED	Placebo	60

Source ClinicalTrials.gov

Adverse events44

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	Nausea	Gastrointestinal disorders	Pramipexole	24	166
other	Nausea	Gastrointestinal disorders	Placebo	6	163
other	Fatigue	General disorders	Pramipexole	18	166
other	Fatigue	General disorders	Placebo	15	163
other	Headache	Nervous system disorders	Pramipexole	13	166
other	Headache	Nervous system disorders	Placebo	17	163
other	Restless legs syndrome	Nervous system disorders	Pramipexole	11	166
other	Restless legs syndrome	Nervous system disorders	Placebo	11	163
other	Somnolence	Nervous system disorders	Pramipexole	11	166
other	Somnolence	Nervous system disorders	Placebo	8	163

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pramipexole
Total, all-cause mortality	Placebo
Total, other adverse events	Pramipexole	70	166
Total, other adverse events	Placebo	58	163
Total, serious adverse events	Pramipexole	8	166
Total, serious adverse events	Placebo	3	163

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons3

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

Comparison	Source
Pramipexole vs Placebo: Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation	Trial comparisons
Pramipexole vs Placebo: Diagnosis of Classified Augmentation According to Independent Expert Panel	Trial comparisons
Pramipexole vs Placebo: 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/NCT00472199

GET https://conductscience.org/api/trials/v1/NCT00472199/registered?page=2

API reference For AI assistants