Restless Legs Syndrome Treatment With Botulinum Toxin

NCT00949806 | Completed Phase 2

• 2 other identifiers: CHUBX 2008/352009-011386-92
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Restless Legs Syndrome (RLS) is a common sensori-motor disorder that causes sensory discomfort and motor restlessness, most often in the legs, which improves with movement. Although medications are available to treat the disorder, many people either experience side effects that prevent them from continuing on the medication or do not sufficiently respond to current RLS medications. Recently, botulinum toxin type A (BNT) has been reported to relief RLS in patients with severe symptoms but this was not confirmed by other anecdotal reports. The investigators propose to test the efficacy of BNT on RLS symptoms by designing a more controlled study. Ultimately, this may lead to extend the therapeutic arsenal of this disorder.

Conditions

Restless Legs Syndrome

Keywords

Botulinum toxin

Outcome Measures

Primary Outcomes (1)

• Efficacy of BNT in the treatment of RLS measured by at least 50% improvement of the RLS severity score as measured by the International Restless Legs Syndrome Severity Scale (IRLSRS) at day 15 following BNT injection

  Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks.

Secondary Outcomes (3)

• Efficacy duration (maintenance of at least 50% improvement of the RLS severity on the IRLSRS at week 6, 12, 18 and 24 compared to baseline severity score

  Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks

• Adverse events of BNT injection

  Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks

• Clinical Global Impression (CGI) improvement

  Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks

Study Arms (1)

Administrated

EXPERIMENTAL

All patients included will receive an intradermal administration of BNT

Drug: BNT (intradermal injection)

Interventions

BNT (intradermal injection) DRUG

Patients with severe RLS will receive a one-time intradermal administration of BNT into the most symptomatic areas of both legs. Injections will be distributed in a grid distribution pattern covering a total of 20 equidistant sites per symptomatic area. Each symptomatic area will receive a maximum 250 units of BNT (12.5 units per injection). The total BNT injected units should not exceed 1000 units per patient.

Administrated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \> 18 years old
• Normal neurological clinical examination
• A minimum score of 21 on the RLS severity rating scale
• Primary RLS diagnosis based on (i) the presence of a characteristic clinical history and on (ii) the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria.
• Medications regimen for RLS must be stabilized for more than 6 weeks prior to entering the study
• informed consent

You may not qualify if:

• Medical history of diabetes, depression, kidney failure, myasthenia
• Iron deficiency
• Pregnancy, lactation, woman of childbearing age without efficient contraceptive method
• Patient undergoing aminosid antibiotherapy or BNT injection for other indication
• Any contra-indication to BNT injection
• Participation to other clinical study within 30 days
• Patient under any administrative or legal supervision

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• IPSEN PHARMA S.A.S: collaborator

Study Sites (1)

CHU de Bordeaux

Pessac, 33600, France

Location

Related Publications (4)

• Rotenberg JS, Canard K, Difazio M. Successful treatment of recalcitrant restless legs syndrome with botulinum toxin type-A. J Clin Sleep Med. 2006 Jul 15;2(3):275-8.

  PMID: 17561538 BACKGROUND

• Ghorayeb I, Burbaud P. Failure of botulinum toxin A to relieve restless legs syndrome. Sleep Med. 2009 Mar;10(3):394-5. doi: 10.1016/j.sleep.2008.03.002. Epub 2008 May 29. No abstract available.

  PMID: 18514023 BACKGROUND

• Nahab FB, Peckham EL, Hallett M. Double-blind, placebo-controlled, pilot trial of botulinum toxin A in restless legs syndrome. Neurology. 2008 Sep 16;71(12):950-1. doi: 10.1212/01.wnl.0000325994.93782.a1. No abstract available.

  PMID: 18794499 BACKGROUND

• Ghorayeb I, Benard A, Vivot A, Tison F, Burbaud P. A phase II, open-label, non-comparative study of Botulinum toxin in Restless Legs Syndrome. Sleep Med. 2012 Dec;13(10):1313-6. doi: 10.1016/j.sleep.2012.08.019. Epub 2012 Oct 11.

  PMID: 23063302 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Injections, Intradermal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Imad GHORAYEB, MD, PhD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 30, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 12, 2026

Record last verified: 2012-07

Locations

FR (1)