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.

Study Overview

• Status: Completed
• Conditions: Flu-like Symptoms

• Study Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Flu-like symtoms, incidence; The frequency of FLS will be estimated by number of patients and number of Botox treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Eight months or 2 treatment cycles

Collaborators and Investigators

• Sponsor: Christine Hunter
• Collaborators: Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (ESTIMATE): April 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 24, 2012
• Last Update Submitted That Met QC Criteria: August 23, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: botulinum toxin; Botox; flu like symptoms; frequency of FLS
• Other Study ID Numbers: H-27678