Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy

NCT01337453 | Completed

• 1 other identifier: H-27678
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

Flu-like Symptoms

Keywords

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

Outcome Measures

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

  Eight months or 2 treatment cycles

Study Arms (1)

Flu-like symtoms, incidence

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Christine Hunter: lead
• Merz North America, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine, Dept. of Neurology

Houston, Texas, 77030, United States

Location

Study Officials

• Joseph Jankovic, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Nurse Manager

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 19, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 24, 2012

Record last verified: 2012-08

Locations

US (1)