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Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy

This study has been completed.
Sponsor:
Collaborator:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Christine Hunter, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01337453
First received: April 14, 2011
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Flu-like Symptoms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy

Resource links provided by NLM:

MedlinePlus related topics: Botox Flu
U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • The frequency of FLS will be estimated by number of patients and number of Botox treatments [ Time Frame: Eight months or 2 treatment cycles ] [ Designated as safety issue: Yes ]
    The frequency of FLS will be estimated by number of patients and number of Botox treatments


Enrollment: 247
Study Start Date: April 2011
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Flu-like symtoms, incidence
The frequency of FLS will be estimated by number of patients and number of Botox treatments.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337453

Locations
United States, Texas
Baylor College of Medicine, Dept. of Neurology
Houston, Texas, United States, 77030
Sponsors and Collaborators
Christine Hunter
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Joseph Jankovic, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Christine Hunter, Research Nurse Manager, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01337453     History of Changes
Other Study ID Numbers: H-27678
Study First Received: April 14, 2011
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
botulinum toxin
flu like symptoms
frequency of FLS
Botox

Additional relevant MeSH terms:
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013