Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome

NCT02025608 | Completed Phase 4 DMC

• 2 other identifiers: NSI.13.01320030_144007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Restless Legs Syndrome

Keywords

Restless legs syndrome

Outcome Measures

Primary Outcomes (1)

• Change in heart rate activations during sleep from baseline to 4 weeks

  Number and amplitude of periodic leg movements during sleep (PLMS) and non-PLMS related heart rate activations during stable nocturnal sleep

  Baseline, Week 4

Secondary Outcomes (2)

• Change in baroreflex from baseline to 4 weeks

  Baseline, Week 4

• Change in blood serum markers from baseline to 4 weeks

  Baseline, Week 4

Other Outcomes (1)

• Change in chemoreflexes from baseline to 4 weeks

  Baseline, Week 4

Study Arms (2)

Pramipexole

EXPERIMENTAL

Pramipexole, 0.25 mg, daily for 4 weeks

Drug: Pramipexole

Placebo

PLACEBO COMPARATOR

Placebo, daily for 4 weeks

Drug: Placebo

Interventions

Pramipexole DRUG

Pramipexole

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate and written informed consent
• Aged 30 to 65 years at the time of screening
• Body mass index (BMI) ≤ 30
• Unremarkable neurological and physical examination
• Unremarkable standard blood parameter according to local reference values
• RLS according to current standard international criteria
• RLS symptoms ≥ 2 times per week for ≥ 1 year and during the past 12 months.
• Either current international RLS severity scale (IRLS) ≥ 15 or current IRLS ≥ 10 and RLS symptoms ≥ 4 times per week during the past 3 months.

You may not qualify if:

• Pregnancy, or breast feeding at time of screening.
• Recent anaesthesia (last 3 months).
• Sleep related breathing disorders during nocturnal polysomnography:
• Current history of psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
• Life time history of any diagnosis of, medication or intervention for cardiovascular diseases.
• Current chronic treatment that may affect autonomic function.
• Any significant neurological disease or diagnosed metabolic diseases that may affect cardiovascular function and/or increase cardiovascular risk.
• Any unstable medical condition.
• Smoking \> 5 cigarettes per day during the last 2 years.
• Work involving night shifts (22:00 - 06:00 h) during the past 2 years.
• Travel with \> 6 time zone differences during the past 6 months.
• Participation in any other study involving investigational or marketed products concomitantly or within 3 months prior to the screening visit.
• Current participation in other clinical trials.
• Exposure to dopaminergic drugs \> 12 months during life time and/or \> 1 week during the past 3 months and/or current or during the past month.
• Exposure to other RLS relevant medication (such as opioids, antiepileptics, clonidine except hypnotics such as benzodiazepines) \> 24 months during life time and/or \> 1 week during the past 3 months and/or current intake.

Sponsors & Collaborators

• Mauro Manconi: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• Cardiocentro Ticino: collaborator

Study Sites (2)

Neurocenter of Southern Switzerland

Lugano, Canton Ticino, 6903, Switzerland

Location

Department of Neurology, Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mauro Manconi, PhD, MD

  Neurocenter of Southern Switzerland

  PRINCIPAL INVESTIGATOR

• Claudio L.A. Bassetti, MD

  Department of Neurology, Inselspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

CH (2)