Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy

NCT ID: NCT01337453

Last Updated: 2012-08-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 247 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Flu-like symtoms, incidence

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

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: collaborator

Christine Hunter

OTHER

Sponsor Role: lead

Responsible Party

Christine Hunter

Research Nurse Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph Jankovic, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine, Dept. of Neurology

Houston, Texas, United States

Countries

United States

Other Identifiers

H-27678

Identifier Type: -

Identifier Source: org_study_id