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NCT Number: NCT01337453

Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy

Botulinum toxin (BoNT) has become a revolutionary treatment for many neurological, autonomic, gastrointestinal, genitourinary, and cosmetic disorders. The use of this treatment requires expertise in dosage calculations and application technique to avoid potential side effects. Most adverse events (AEs) related to BoNT are local and related to its mechanism of action, i.e., paralysis of unwanted muscles. However, systemic AEs may also be observed. Flu-like symptoms (FLS) are well recognized AEs in patients treated with BoNT; however there is a paucity of information regarding the frequency, clinical impact, and associated risk factors of this particular complication.

Between December 1989 and May 2003, 1,437 reports of BoNT-related AEs were registered at the Food and Drug Administration (FDA). FLS were reported in 4.6% of serious, and 3.2% of non-serious side effects.

In this study, the investigators aim to assess prospectively the frequency, clinical characteristics, and risk factors for development of FLS in a group of patients affected with diverse movement disorders and treated with BoNT type A at the Parkinson's Disease Center and Movement Disorders Clinic (PDCMDC) of Baylor College of Medicine (BCM). The investigators will also assess biomarker of inflammatory response in those patients who develop FLS after treatment with BoNT.

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Key information

Conditions

Flu-like Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor College of Medicine, Dept. of Neurology

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with any movement disorder: dystonia, tremor, tics, myoclonus or tardive dyskinesias and treated with botulinum toxin type A (Botox or Dysport) to type B (Myobloc)
  • Patients who will be injected in at least two consecutive visits in our clinic, three months apart.
  • We will invite patients who are regularly treated in our clinic "established patients" and those who will be treated for the first time "new patients".
  • Patients who are willing to complete with the study requirements.
  • Patients who deny the blood sample will be included for the symptoms and risk factors analysis.
  • Patients who give written informed consent.

Exclusion criteria

  • Patients who will only be injected with BoNT once in our clinic at BCM.
  • Patients who deny participating in the clinical survey.

Treatment and study plan

Primary outcomes

  1. The frequency of FLS will be estimated by number of patients and number of Botox treatments

    Time frame: Eight months or 2 treatment cycles

    The frequency of FLS will be estimated by number of patients and number of Botox treatments

Sponsors and collaborators

Lead sponsor

Christine Hunter

Other

Collaborators

  • Merz North America, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2011
Registry last updated
Aug 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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