Restless Legs Syndrome Treatment With Botulinum Toxin (SOXIS)

This study has been completed.
Sponsor:
Collaborator:
IPSEN PHARMA S.A.S
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00949806
First received: July 29, 2009
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Restless Legs Syndrome
Drug: BNT (intradermal injection)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Non Comparative, Open Study to Assess the Efficacy and Safety of the Botulinum Toxin Type A in Patients With Restless Legs Syndrome (RLS)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 [ Time Frame: Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events of BNT injection [ Time Frame: Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Global Impression (CGI) improvement [ Time Frame: Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: August 2009
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Administrated
All patients included will receive an intradermal administration of BNT
Drug: BNT (intradermal injection)

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.


Detailed Description:

The restless legs syndrome (RLS) is a chronic sensori-motor disorder affecting an estimated 7.2% to 11.5% of the adult population. It is characterised by a complaint of an irresistible urge to move the legs. This urge can often be accompanied by pain or other uncomfortable and unpleasant sensations, it either occurs or worsens with rest particularly at night, and improves with activity. RLS is diagnosed clinically by means of the four essential criteria established by the International Restless Legs Syndrome Study Group.

There is still no comprehensive understanding of the underlying pathophysiological processes of RLS, but the evidence for a primary dopaminergic role in RLS is to be found in the excellent pharmacological response to low-dose dopaminergic medications. Another recent evidence suggests an enhanced sensitization of central pain processing in patients with RLS. This had led to consider the botulinum toxin type A (BNT) as an alternative treatment in patients refractory to current RLS medications or in those suffering from adverse events. The therapeutic benefit of BNT injection in patients with recalcitrant RLS has been anecdotally reported lately but not confirmed by other reports.

The aim of our study is to evaluate the efficacy and tolerance of intradermal BNT injection in severely affected patients with idiopathic RLS.

For this we designed a phase II non comparative, open study. 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.

Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks following BNT administration and assessed by mean of the International RLS Rating Scale and Clinical Global Impression Scale.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949806

Locations
France
CHU de Bordeaux
Pessac, France, 33600
Sponsors and Collaborators
University Hospital, Bordeaux
IPSEN PHARMA S.A.S
Investigators
Principal Investigator: Imad GHORAYEB, MD, PhD University Hospital Bordeaux, France
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00949806     History of Changes
Other Study ID Numbers: CHUBX 2008/35
Study First Received: July 29, 2009
Last Updated: July 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Botulinum toxin

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014