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

Primary Purpose

Restless Legs Syndrome

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Pramipexole

Placebo

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local Institutional Review Board/Independent Ethics Committee (IRB/IEC) requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments
Male or female out-patients aged 18-85 years
Diagnosis of idiopathic RLS according to the clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG) [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS.
RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2)
IRLS total score >15 at baseline (Visit 2)

Exclusion Criteria:

Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner's surgical sterilization
Any woman of child-bearing potential not having a negative pregnancy test at screening
Breastfeeding women
Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets
Diagnosis of augmentation under previous pharmacological RLS treatment
Concomitant or previous pharmacologic therapy as follows: Any intake of dopamine agonists within 14 days prior to baseline (Visit 2); Any intake of levodopa within 14 days prior to baseline (Visit 2); Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole);

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pramipexole

Placebo

Arm Description

4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase or decrease the dose in steps to 0.25 mg, 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks.

4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks

IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)

Secondary Outcome Measures

Clinical Global Impression - Global Improvement (CGI-I) Responder Rate

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)

International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate

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)

Patient Global Impression (PGI) Responder Rate

PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)

Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks

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

Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks

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

Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks

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

Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks

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

Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks

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

Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks

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

Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks

Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)

Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks

The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm)

Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks

RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life

Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating less bodily pain

Change From Baseline in SF-36 Dimension General Health After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better health status

Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better mental health

Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better physical functioning

Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems

Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems

Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better social functioning

Change From Baseline in SF-36 Dimension Vitality After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better vitality

Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better health

Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better health

Diagnosis of Classified Augmentation According to Independent Expert Panel

Augmentation is a worsening of RLS symptoms and may manifest as increased severity and the involvement of other extremities or as a shift of RLS symptoms to a time period that is 2 or more hours earlier than was typical of the time of symptom onset during the initial course of beneficial stable treatment or the state before recently starting treatment.

Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation

Worsening of RLS symptoms, in comparison to baseline, following abrupt treatment discontinuation (for patients with no added RLS therapy after study drug discontinuation). Assessment of worsening of RLS was based on the IRLS total score assessed 7 ± 1 days after treatment discontinuation (the end of the study or premature discontinuation) compared with that at baseline. Analysis considered the number of patients experiencing a clinically relevant deterioration of ≥4 points in total IRLS score 7 ± 1 days after discontinuation of trial medication compared with baseline.

Baseline, Week 26 Mean Supine Systolic Blood Pressure

Baseline, Week 26 Mean Standing Systolic Blood Pressure

Baseline, Week 26 Mean Supine Diastolic Blood Pressure

Baseline, Week 26 Mean Standing Diastolic Blood Pressure

Baseline, Week 26 Mean Supine Pulse Rate

Baseline, Week 26 Mean Standing Pulse Rate

Full Information

NCT ID

NCT00472199

First Posted

May 10, 2007

Last Updated

June 17, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00472199

Brief Title

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

Official Title

A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol, Mirapexin) 0.125-0.75 mg/Day Per os to Investigate the Long-term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by a 26 Week Open-label Extension Treatment Period

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo. The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

331 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pramipexole

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks.

Intervention Type

Drug

Intervention Name(s)

Pramipexole

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks

Description

IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)

Time Frame

Baseline and 26 weeks

Secondary Outcome Measure Information:

Title

Clinical Global Impression - Global Improvement (CGI-I) Responder Rate

Description

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)

Time Frame

after 26 weeks of treatment

Title

International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate

Description

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)

Time Frame

after 26 weeks of treatment

Title

Patient Global Impression (PGI) Responder Rate

Description

PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)

Time Frame

after 26 weeks of treatment

Title

Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks

Description

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

Time Frame

baseline and 26 weeks of treatment

Title

Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks

Description

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

Time Frame

Baseline and 26 weeks of treatment

Title

Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks

Description

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

Time Frame

baseline and 26 weeks of treatment

Title

Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks

Description

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

Time Frame

Baseline and 26 weeks of treatment

Title

Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks

Description

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

Time Frame

Baseline and 26 weeks of treatment

Title

Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks

Description

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

Time Frame

Baseline and 26 weeks of treatment

Title

Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks

Description

Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)

Time Frame

Baseline and 26 weeks of treatment

Title

Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks

Description

The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm)

Time Frame

Baseline and 26 weeks of treatment

Title

Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks

Description

RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life

Time Frame

Baseline and 26 weeks of treatment

Title

Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating less bodily pain

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in SF-36 Dimension General Health After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating better health status

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating better mental health

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating better physical functioning

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating better social functioning

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in SF-36 Dimension Vitality After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating better vitality

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating better health

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks

Description

Score ranging from 0 to 100 with higher scores indicating better health

Time Frame

Baseline and 26 weeks

Title

Diagnosis of Classified Augmentation According to Independent Expert Panel

Description

Time Frame

after at least 4 weeks of treatment

Title

Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation

Description

Time Frame

after at least 1 week of treatment discontinuation

Title

Baseline, Week 26 Mean Supine Systolic Blood Pressure

Time Frame

Baseline, Week 26

Title

Baseline, Week 26 Mean Standing Systolic Blood Pressure

Time Frame

Baseline, Week 26

Title

Baseline, Week 26 Mean Supine Diastolic Blood Pressure

Time Frame

Baseline, Week 26

Title

Baseline, Week 26 Mean Standing Diastolic Blood Pressure

Time Frame

Baseline, Week 26

Title

Baseline, Week 26 Mean Supine Pulse Rate

Time Frame

Baseline, Week 26

Title

Baseline, Week 26 Mean Standing Pulse Rate

Time Frame

Baseline, Week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local Institutional Review Board/Independent Ethics Committee (IRB/IEC) requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments Male or female out-patients aged 18-85 years Diagnosis of idiopathic RLS according to the clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG) [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS. RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2) IRLS total score >15 at baseline (Visit 2) Exclusion Criteria: Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner's surgical sterilization Any woman of child-bearing potential not having a negative pregnancy test at screening Breastfeeding women Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets Diagnosis of augmentation under previous pharmacological RLS treatment Concomitant or previous pharmacologic therapy as follows: Any intake of dopamine agonists within 14 days prior to baseline (Visit 2); Any intake of levodopa within 14 days prior to baseline (Visit 2); Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole);

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

248.629.4302 Boehringer Ingelheim Investigational Site

City

Innsbruck

Country

Austria

Facility Name

248.629.4304 Boehringer Ingelheim Investigational Site

City

Linz

Country

Austria

Facility Name

248.629.3201 Boehringer Ingelheim Investigational Site

City

Edegem

Country

Belgium

Facility Name

248.629.35801 Boehringer Ingelheim Investigational Site

City

Espoo

Country

Finland

Facility Name

248.629.35805 Boehringer Ingelheim Investigational Site

City

Helsinki

Country

Finland

Facility Name

248.629.35804 Boehringer Ingelheim Investigational Site

City

Joensuu

Country

Finland

Facility Name

248.629.35802 Boehringer Ingelheim Investigational Site

City

Oulu

Country

Finland

Facility Name

248.629.35806 Boehringer Ingelheim Investigational Site

City

Tampere

Country

Finland

Facility Name

248.629.4904 Boehringer Ingelheim Investigational Site

City

Berlin (Hellersdorf)

Country

Germany

Facility Name

248.629.4903 Boehringer Ingelheim Investigational Site

City

Berlin-Steglitz

Country

Germany

Facility Name

248.629.4902 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

248.629.4908 Boehringer Ingelheim Investigational Site

City

Bochum

Country

Germany

Facility Name

248.629.4901 Boehringer Ingelheim Investigational Site

City

Ellwangen

Country

Germany

Facility Name

248.629.4906 Boehringer Ingelheim Investigational Site

City

Herborn

Country

Germany

Facility Name

248.629.4905 Boehringer Ingelheim Investigational Site

City

Leipzig

Country

Germany

Facility Name

248.629.4909 Boehringer Ingelheim Investigational Site

City

Schwerin

Country

Germany

Facility Name

248.629.4907 Boehringer Ingelheim Investigational Site

City

Würzburg

Country

Germany

Facility Name

248.629.35301 Boehringer Ingelheim Investigational Site

City

Carrigtwohill

Country

Ireland

Facility Name

248.629.35302 Boehringer Ingelheim Investigational Site

City

Co. Kildare

Country

Ireland

Facility Name

248.629.35303 Boehringer Ingelheim Investigational Site

City

Co. Tipperary

Country

Ireland

Facility Name

248.629.31001 Boehringer Ingelheim Investigational Site

City

Bennebroek

Country

Netherlands

Facility Name

248.629.31005 Boehringer Ingelheim Investigational Site

City

Hoogwoud

Country

Netherlands

Facility Name

248.629.31006 Boehringer Ingelheim Investigational Site

City

Musselkanaal

Country

Netherlands

Facility Name

248.629.31002 Boehringer Ingelheim Investigational Site

City

Oude Pekela

Country

Netherlands

Facility Name

248.629.31003 Boehringer Ingelheim Investigational Site

City

Oude Pekela

Country

Netherlands

Facility Name

248.629.31004 Boehringer Ingelheim Investigational Site

City

Rijswijk

Country

Netherlands

Facility Name

248.629.4204 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

248.629.4205 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

248.629.4202 Boehringer Ingelheim Investigational Site

City

Brezno

Country

Slovakia

Facility Name

248.629.4201 Boehringer Ingelheim Investigational Site

City

Kosice

Country

Slovakia

Facility Name

248.629.4203 Boehringer Ingelheim Investigational Site

City

Martin

Country

Slovakia

Facility Name

248.629.3402 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

248.629.3405 Boehringer Ingelheim Investigational Site

City

Granada

Country

Spain

Facility Name

248.629.3401 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

248.629.3403 Boehringer Ingelheim Investigational Site

City

San Sebastián

Country

Spain

Facility Name

248.629.3406 Hospital Arnau de Vilanova

City

Valencia

Country

Spain

Facility Name

248.629.44003 Boehringer Ingelheim Investigational Site

City

Chorley

Country

United Kingdom

Facility Name

248.629.44006 Boehringer Ingelheim Investigational Site

City

Edgbaston, Birmingham

Country

United Kingdom

Facility Name

248.629.44004 Boehringer Ingelheim Investigational Site

City

Glasgow

Country

United Kingdom

Facility Name

248.629.44001 Boehringer Ingelheim Investigational Site

City

Manchester

Country

United Kingdom

Facility Name

248.629.44002 Boehringer Ingelheim Investigational Site

City

Reading

Country

United Kingdom

Facility Name

248.629.44005 Boehringer Ingelheim Investigational Site

City

Waterloo, Liverpool

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.629_U09-0147-01-DS.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.629_Literature.pdf

Description

Related Info

Learn more about this trial

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

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

Restless Legs Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial