Flu-like SymptomsNCT01337453
Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy
An observational study of Flu-like Symptoms, run by Christine Hunter at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flu-like Symptoms
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who will only be injected with BoNT once in our clinic at BCM.
- Patients who deny participating in the clinical survey.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine, Dept. of Neurology
Houston, Texas, 77030
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Flu-like symtoms, incidence | The frequency of FLS will be estimated by number of patients and number of Botox treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Eight months or 2 treatment cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flu-like SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christine Hunter
- Sponsor type
- University, hospital or other
- Collaborators
- Merz North America, Inc.
- Responsible party
- Sponsor-investigator, Christine Hunter, Baylor College of Medicine
- Investigators
- Joseph Jankovic, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337453
- Sponsor's protocol ID
- H-27678
- Status last verified
- Aug 2012
- First submitted
- 14 Apr 2011
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy
- ClinicalTrials.gov ID
- NCT01337453
- Acronym / sponsor ID
- H-27678
- Conditions
- Flu-like Symptoms
- Keywords
- botulinum toxin, flu like symptoms, frequency of FLS, Botox
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Christine HunterUniversity, hospital or other
- Collaborators
- Merz North America, Inc.
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flu-like symtoms, incidence | – | –The frequency of FLS will be estimated by number of patients and number of Botox treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who will only be injected with BoNT once in our clinic at BCM.
- Patients who deny participating in the clinical survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The frequency of FLS will be estimated by number of patients and number of Botox treatments
Time frame: Eight months or 2 treatment cycles
The frequency of FLS will be estimated by number of patients and number of Botox treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Jankovic, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flu-like Symptoms, run by Christine Hunter at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of FLS will be estimated by number of patients and number of Botox treatments (time frame: Eight months or 2 treatment cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.