Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy
Public ClinicalTrials.gov record NCT01337453. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01337453
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 247 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2011
- Primary completion
- May 31, 2012
- Completion
- Jun 30, 2012
- Last update posted
- Aug 23, 2012
2011 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baylor College of Medicine, Dept. of Neurology | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01337453, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 23, 2012 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01337453 live on ClinicalTrials.gov.