Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

Pramipexole

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female 18-80 years Confident diagnosis of RLS according to International RLS Study Group criteria RLS rating scale for severity score >15 PLM (during time in bed ) index at least 5 per hour Weekly presence of RLS symptoms within last three months Written Informed consent Exclusion Criteria: Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception Postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection Women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom Any women not having negative serum pregnancy test at screening

Sites / Locations

NEURO

Outcomes

Primary Outcome Measures

Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG).

Secondary Outcome Measures

Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS), and patient reported outcomes).

Full Information

NCT ID

NCT00239486

First Posted

October 14, 2005

Last Updated

October 31, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00239486

Brief Title

Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)

Official Title

Evaluation of the Effect of Different Doses of Pramipexole on Subjective and Objective Symptoms of Idiopathic Restless Legs Syndrome (RLS).

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

April 2004 (Actual)

Study Completion Date

April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of different doses of pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs Syndrome (RLS) and also to determine the optimal dose of pramipexole in patients with RLS by polysomnography and evaluation of clinical improvement.

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 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

109 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pramipexole

Primary Outcome Measure Information:

Title

Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG).

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS), and patient reported outcomes).

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Male and female 18-80 years Confident diagnosis of RLS according to International RLS Study Group criteria RLS rating scale for severity score >15 PLM (during time in bed ) index at least 5 per hour Weekly presence of RLS symptoms within last three months Written Informed consent Exclusion Criteria: Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception Postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection Women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom Any women not having negative serum pregnancy test at screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim Study Coordinator

Organizational Affiliation

B.I. Finland Ky

Official's Role

Study Chair

Facility Information:

Facility Name

NEURO

City

Helsinki

ZIP/Postal Code

FIN-00250

Country

Finland

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.515_U04-2112.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.515_literature.pdf

Description

Related Info

Restless Legs Syndrome

About this trial

Eligibility Criteria

Sites / Locations

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