Pilot trial of onabotulinumtoxina (Botox) in moderate to severe restless legs syndrome.

Abstract

OBJECTIVE:

To evaluate the potential of onabotulinum toxin A (Botox®, Allergan, Inc., Irvine, California) in the treatment of restless legs syndrome (RLS).

METHODS:

A single-arm, open-label pilot trial of onabotulinum toxin A was conducted to determine its usefulness as an injectable treatment for RLS.

RESULTS:

The primary outcome measure, change in score on the International Restless Legs Syndrome Scale, showed a statistically significant improvement in RLS during the first 4 weeks after treatment. Two of the secondary outcome measures, pain (measured using a visual analog scale) and patients' global impression of severity of illness also showed improvement.

CONCLUSIONS:

Onabotulinum toxin A warrants further study in RLS. Increasing the drug dosage, changing the dosing schedule, and increasing the number of injection sites may result in greater activity and longer duration of action.

• Authors: Pinky Agarwal, Cherri Sia, Narendra Vaish, Ina Roy-Faderman
• Journal: The International journal of neuroscience (Int J Neurosci) Vol. 121 Issue 11 Pg. 622-5 (Nov 2011) ISSN: 1563-5279 [Electronic] England
• PMID: 21740308 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Botulinum Toxins, Type A (administration & dosage, adverse effects)
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Neuromuscular Agents (administration & dosage, adverse effects)
• Patient Satisfaction
• Pilot Projects
• Restless Legs Syndrome (drug therapy, physiopathology)
• Severity of Illness Index
• Sleep Wake Disorders (drug therapy, etiology, physiopathology)
• Young Adult