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CompletedNCT01337453Updated Aug 24, 2012

Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy

An observational study in Flu-like Symptoms, sponsored by Christine Hunter. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-24.

Sponsored by Christine Hunter · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
247
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Flu-like Symptoms

Keywords

  • botulinum toxin
  • flu like symptoms
  • frequency of FLS
  • Botox
03

In context

Lead sponsor

This is the only study on the registry with Christine Hunter as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

  1. The investigators plan to study 300 consecutive patients treated with BoNT at the Parkinson Disease center and Movement Disorders Clinic (PDCMDC) of Baylor College of Medicine.
  2. The investigators will invite patients to participate in the study during an eight-month period that includes two cycles of BoNT injections. All patients within this period will be invited to take part in the clinical study. This will include patients who have never been injected in our clinic and are considered as "new" patients; and patients who are followed on a regular basis in our clinic and are considered as "established" patients.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
247 participants (actual)

Groups and cohorts

  • Flu-like symtoms, incidence

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Eight months or 2 treatment cycles

07

Study locations

1 site
  • Baylor College of Medicine, Dept. of Neurology
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01337453
Lead sponsor
Christine Hunter
Collaborators
Merz North America, Inc.
Responsible party
Christine Hunter (Research Nurse Manager, Baylor College of Medicine) — Sponsor-investigator
First posted
Apr 19, 2011
Start date
Apr 2011
Primary completion
Jun 2012
Completion
Jul 2012
Last update
Aug 24, 2012

Study contacts

Joseph Jankovic, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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