Last updated: 11/06/2018 23:41:27
A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS)
Trial description: A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Haan J, Volc D, Montplaisir J. The long-term management of RLS with ropinirole: maintained efficacy over 36 weeks. International Congress of Parkinson’s Disease and Movement Disorders, Rome, Italy, Jun 13–17 2004. Mov Disord 2004; 19(suppl 9): S420: P1232
Montplaisir, J 1; Karrasch, J 2; Haan, J 3; Kruger, AJ 4, and Volc, D 5, 2681061 (1) Sleep Disorders Clinic, Hopital du Sacre-Coeur de Montreal, Montreal, QC, Canada; 2) Peninsula Clinical Research Centre, Kipparing, QLD, Australia; 3) Kliniken Maria Hilf GmbH, Neurologische Klinik, Schlafmedizinisches Zentrum, Moenchengladbach, Germany; 4) Neurology Department, University of The Free State, Bloemfontein, Free State, South Africa; 5) Confraternitaet - Privatklinik, Josefstadt, Wien, Austria). The Impact of Ropinirole Treatment on RLS Symptoms and Health-Related Quality of Life (HRQoL) in Patients with RLS: Results of a Multinational 36-Week Study [656]. 6/5/2004: 1) Sleep Disorders Clinic, Hopital du Sacre-Coeur de Montreal Montreal QC Canada; 2) Peninsula Clinical Research Centre, Kipparing QLD Australia; 3) Kliniken Maria Hilf GmbH, Neurologische Klinik Schlafmedizinisches Zentrum Moenchengladbach Germany; 4) Neurology Department, University of The Free State Bloemfontein Free State
Montplaisir, Jacques 1; Karrasch, Jeff 2; Haan, Jean 3; Kruger, Abraham J. 4, and Volc, Dieter 5, 2556012 (1) Montreal, QC, Canada; 2) Kipparing, Australia; 3) Moenchengladbach, Germany; 4) Bloemfontein, South Africa; 5) Vienna, Austria). The Impact of Ropinirole Treatment on Health-Related Quality of Life (HRQoL) in Patients with RLS: Results of a Multinational 36-Week Study [P01.080]. 4/24/2004: 1) Montreal, QC Canada; 2) Kipparing, Australia; 3) Moenchengladbach, Germany; 4) Bloemfontein, South Africa, and 5) Vienna, Austria, 5/1/2004. 56th Annual Meeting of the American Academy of Neurology; San Francisco, CA; USA. San Francisco, CA; USA; 2004 Apr 24; c2004.
Medical condition
Restless Legs Syndrome
Product
ropinirole
Collaborators
Not applicable
Study date(s)
November 2001 to February 2003
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-05-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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