Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome

Phase 4

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Pramipexole; Drug: Placebo

• Registration Number: NCT02025608
• Lead Sponsor: Mauro Manconi

Brief Summary

The purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with RLS.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2014-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pramipexole	Pramipexole	Pramipexole, 0.25 mg, daily for 4 weeks
Placebo	Placebo	Placebo, daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in heart rate activations during sleep from baseline to 4 weeks	Baseline, Week 4	Number and amplitude of periodic leg movements during sleep (PLMS) and non-PLMS related heart rate activations during stable nocturnal sleep

Secondary Outcome Measures

Name	Time	Method
Change in baroreflex from baseline to 4 weeks	Baseline, Week 4	Baroreflex sensitivity and baroreflex gain derived from tilt table tes
Change in blood serum markers from baseline to 4 weeks	Baseline, Week 4	Highly-sensitive C reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (lP-PLA2), and oxidised low density lipoprotein (oxLDL)

Trial Locations

Locations (2)

Department of Neurology, Inselspital; 🇨🇭 Bern, Switzerland

Neurocenter of Southern Switzerland; 🇨🇭 Lugano, Ticino, Switzerland