Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01337453

Enrollment

247

Registered

2011-04-19

Start date

2011-04-30

Completion date

2012-07-31

Last updated

2012-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flu-like Symptoms

Keywords

botulinum toxin, flu like symptoms, frequency of FLS, Botox

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 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) 2. Patients who will be injected in at least two consecutive visits in our clinic, three months apart. 3. 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. 4. Patients who are willing to complete with the study requirements. 5. Patients who deny the blood sample will be included for the symptoms and risk factors analysis. 6. Patients who give written informed consent.

Exclusion criteria

1. Patients who will only be injected with BoNT once in our clinic at BCM. 2. Patients who deny participating in the clinical survey.

Design outcomes

Primary

Measure	Time frame	Description
The frequency of FLS will be estimated by number of patients and number of Botox treatments	Eight months or 2 treatment cycles	The frequency of FLS will be estimated by number of patients and number of Botox treatments

Countries

United States

Outcome results