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Restless Legs SyndromePhase 3NCT00152958

A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

A Phase 3 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 12 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to assess sustained efficacy in patients who have responded to a 6 month treatment with open-label pramipexole. Secondary objectives are the measurement of severity of the RLS, assessment of early withdrawal phenomena after termination of trial medication, augmentation under treatment… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Restless Legs Syndrome
What is being tested?
Pramipexole
How many people
224 participants
Where
12 sitesGermany
Study dates
Jan 2004to Feb 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female out-patients aged 18-80
  • Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group
  • RLSRS score > 15
  • RLS symptoms present at least 2 to 3 days per week within the last 3 months
  • Written informed consent

Who cannot join

  • Women of childbearing potential without adequate contraception, or breastfeeding
  • Concomitant or previous pharmacologically therapy of RLS
  • Clinically significant renal disease, and/or hepatic disease
  • Any of the following lab results at screening: Hb, TSH, T3 or T4, clinically significantly out of normal range, positive urine drug screen
  • Other clinically significant metabolic-endocrine (including diabetes mellitus requiring insulin therapy), haematological, gastro-intestinal disease or pulmonary disease . Poorly controlled cardiovascular disease
  • History or clinical signs of peripheral neuropathy (PNP), myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms, history of or clinical signs for any form of epilepsy or seizures
Show all 11Show fewer
  • Presence of any sleep disorder
  • History of schizophrenia or any psychotic disorder, history of mental disorders, alcohol abuse or drug addiction
  • History of or clinical signs of malign neoplasm
  • Patients on a shift-work-schedule, or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated
  • Allergic to pramipexole or its excipients

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • Boehringer Ingelheim Investigational Site

    Berlin

  • Charité Campus Virchow-Klinikum

    Berlin

  • emovis GmbH

    Berlin

  • Boehringer Ingelheim Investigational Site

    Chemnitz

  • ClinPharm Internat. GmbH & Co. KG

    Görlitz

  • Clinpharm International GmbH & Co. KG

    Hellersdorf

  • Paracelsus-Elena-Klinik

    Kassel

  • ClinPharm International GmbH & Co. KG

    Leipzig

  • Neurologische Klinik der Otto-von-Guericke-Universität

    Magdeburg

  • Universitätsklinikum Giessen und Marburg

    Marburg

  • Boehringer Ingelheim Investigational Site

    München

  • Boehringer Ingelheim Investigational Site

    Würzburg

Other trials in Germany

About this study

Official title: A Double-blind, Placebo-controlled, Randomised Withdrawal Study of 3 Month Duration in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

The primary objective is to assess sustained efficacy in patients who have responded to a 6 month treatment with open-label pramipexole.

Secondary objectives are the measurement of severity of the RLS, assessment of early withdrawal phenomena after termination of trial medication, augmentation under treatment, sleepiness, quality of life and subjective wellbeing, the physician's clinical assessment of symptom severity and improvement. Another secondary objective is safety and tolerability of treatment.

Being tested
Pramipexole
Medical subject headings
Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PramipexoleDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to target event (CGI-I rating in association with RLSRS score above 15, period 2) for full analysis set

    Measured: from randomization up to 3 months

Secondary outcomes (24)

  1. Time to target event for per protocol set (period 2)

    Measured: from randomization up to 3 months

  2. Number of target events (period 2)

    Measured: from randomization up to 3 months

  3. Change from baseline (visit 10) in the total score of Restless Legs Syndrome Rating Scale for Severity (RLSRS) (period 2)

    Measured: from randomization up to 3 months

  4. Clinical Global Impressions - Global Improvement (period 2)

    Measured: from randomization up to 3 months

  5. Change from baseline (visit 10) in Clinical Global Impressions - Severity of illness score (CGI-S) by 2 or more categories (period 2)

    Measured: from randomization up to 3 months

  6. Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 2)

    Measured: from randomization up to 3 months

  7. Clinical Global Impressions - Side Effects (CGI-SE) (period 2)

    Measured: from randomization up to 3 months

  8. Change in Patient global impression (PGI) (period 2)

    Measured: from randomization up to 3 months

  9. Change from baseline (visit 10) in Johns Hopkins Quality of Life (RLS-QoL) score (period 2)

    Measured: from randomization up to 3 months

  10. Change from baseline (visit 10) in Visual analogue scales (RLS-VASs) for assessment of RLS symptoms (period 2)

    Measured: from randomization up to 3 months

  11. Change from baseline (visit 10) in Epworth sleepiness scale (ESS)

    Measured: from randomization up to 3 months

  12. Change from baseline (visit 2) in Augmentation severity rating scale of IRLSSG (ASRS) (period 2)

    Measured: up to 9 months

  13. Change from baseline ASRS (period 1)

    Measured: up to 6 months

  14. Change from baseline in the total score of RLSRS (period 1)

    Measured: up to 6 months

  15. RLSRS responder status by visit (non-responder, partial responder, responder) (period 1)

    Measured: after 6 months

  16. RLSRS responder status for patients who discontinued the study prematurely in period 1 by reason for discontinuation (period 1)

    Measured: up to 6 months

  17. Clinical Global Impressions - Global Improvement (period 1)

    Measured: 6 months

  18. Clinical Global Impressions - Severity of illness score (CGI-S) (period 1)

    Measured: 6 months

  19. Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 1)

    Measured: 6 months

  20. Clinical Global Impressions - Side Effects (CGI-TE) (period 1)

    Measured: 6 months

  21. Change in patient global impression from baseline (period 1)

    Measured: 6 months

  22. Change from baseline in Johns Hopkins Quality of Life (RLS-QoL) score (period 1)

    Measured: 6 months

  23. Change from baseline in RLS-VASs (period 1)

    Measured: 6 months

  24. Change from baseline in ESS

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startJan 2004
  3. Primary completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
224 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00152958
Sponsor's protocol ID
248.546
Status last verified
Nov 2013
First submitted
8 Sep 2005
Last updated
19 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 12 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to target event (CGI-I rating in association with RLSRS score above 15, period 2) for full analysis set (time frame: from randomization up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00152958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.

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