DysphoniaNCT03543150
BOTOX® Drug Use Investigation (Spasmodic Dysphonia)
An observational study of Dysphonia, run by GlaxoSmithKline at 1 site in Japan.
Trial summary
This study is a drug use investigation program of BOTOX. The objective of this investigation is to collect and assess information on the safety and efficacy of BOTOX injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysphonia
- What is being tested?
- BOTOX
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteJapan
- Study dates
- 20 Jul 2018to 28 Feb 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects receiving BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study.
Who may be able to join
- All subjects treated with Botox for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia are included in this study.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Tokyo, 107-0052
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: Botox Drug Use Investigation (Spasmodic Dysphonia)
This study is a drug use investigation program of BOTOX. The objective of this investigation is to collect and assess information on the safety and efficacy of BOTOX injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. All subjects treated with BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study. Approximately 400 subjects will be included in the study. The observation period per subject will be up to 12 months from the date of the first administration of BOTOX. The total study duration will be will be approximately 3 years from the date of approval for the indication of BOTOX for spasmodic dysphonia. BOTOX is a registered trademark of Allergan, Inc.
- Conditions
- Dysphonia
- Being tested
- BOTOX
- Keywords
- Spasmodic Dysphonia, VHI-10 scores, BOTOX, Drug use investigation
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOXDrug
BOTOX injections will be administered to eligible subjects with diagnosis of spasmodic dysphonia. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving BOTOX | Subjects with a diagnosis of spasmodic dysphonia, for which BOTOX is indicated, will be included. Receives: Drug: BOTOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse drug reactions
The investigator will collect the information about all adverse drug reactions including diseases and symptoms, occurring after the first administration of Botox, regardless of whether they are related to BOTOX.
Measured: Up to 1 year
Change from Baseline in voice handicap index (VHI)-10 scores
The VHI is a 30-item questionnaire divided into 3 subsections including functional, physical, and emotional which measures the effect of voice problems on quality of life. Subjects will mark each item on this 30-item questionnaire on a scale ranging from 0-4 (0 being never and 4 being always). Points for each subscale are tallied and a total composite score is also given. A total score of 0-11 is considered normal, 12-28 is considered mild minimal handicap, 29-56 is considered moderate handicap, and 57-120 is considered severe handicap.
Measured: Baseline and up to 1 year
Efficacy rate based on global assessment of efficacy
The efficacy rate is the number of subjects assessed as "effective" based on the course of subjective symptoms and clinical symptoms during the observation period from the date of the first administration of BOTOX injections.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start20 Jul 2018
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543150
- Sponsor's protocol ID
- 208506
- Status last verified
- Oct 2021
- First submitted
- 18 May 2018
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Iimura S, Nose Y, Tabata K, Oda K, Yamashita Y, Takahashi N, Kawano Y. Safety and Effectiveness of OnabotulinumtoxinA in Patients with Laryngeal Dystonia: Final Report of a 52-Week, Multicenter Postmarketing Surveillance Study. Toxins (Basel). 2023 Sep 5;15(9):553. doi: 10.3390/toxins15090553.
PubMed 37755979
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botox Drug Use Investigation (Spasmodic Dysphonia)
- ClinicalTrials.gov ID
- NCT03543150
- Acronym / sponsor ID
- 208506
- Conditions
- Dysphonia
- Keywords
- Spasmodic Dysphonia, VHI-10 scores, BOTOX, Drug use investigation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 1 Jun 2018 (actual)
- 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.
This study is a drug use investigation program of BOTOX. The objective of this investigation is to collect and assess information on the safety and efficacy of BOTOX injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. All subjects treated with BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study. Approximately 400 subjects will be included in the study. The observation period per subject will be up to 12 months from the date of the first administration of BOTOX. The total study duration will be will be approximately 3 years from the date of approval for the indication of BOTOX for spasmodic dysphonia. BOTOX is a registered trademark of Allergan, Inc.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving BOTOX | – | Drug: BOTOXSubjects with a diagnosis of spasmodic dysphonia, for which BOTOX is indicated, will be included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects receiving BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study.
Key inclusion criteria (1 listed)
- All subjects treated with Botox for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia are included in this study.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOTOXBOTOX injections will be administered to eligible subjects with diagnosis of spasmodic dysphonia. Dose unit, daily dose frequency, date of administration will be at the investigator discretion. | Drug | Subjects receiving BOTOX |
Primary outcome
Number of subjects with adverse drug reactions
Time frame: Up to 1 year
The investigator will collect the information about all adverse drug reactions including diseases and symptoms, occurring after the first administration of Botox, regardless of whether they are related to BOTOX.
Change from Baseline in voice handicap index (VHI)-10 scores
Time frame: Baseline and up to 1 year
The VHI is a 30-item questionnaire divided into 3 subsections including functional, physical, and emotional which measures the effect of voice problems on quality of life. Subjects will mark each item on this 30-item questionnaire on a scale ranging from 0-4 (0 being never and 4 being always). Points for each subscale are tallied and a total composite score is also given. A total score of 0-11 is considered normal, 12-28 is considered mild minimal handicap, 29-56 is considered moderate handicap, and 57-120 is considered severe handicap.
Efficacy rate based on global assessment of efficacy
Time frame: Up to 1 year
The efficacy rate is the number of subjects assessed as "effective" based on the course of subjective symptoms and clinical symptoms during the observation period from the date of the first administration of BOTOX injections.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Derived from this study: PubMed 37755979Iimura S, Nose Y, Tabata K, Oda K, Yamashita Y, Takahashi N, Kawano Y. Safety and Effectiveness of OnabotulinumtoxinA in Patients with Laryngeal Dystonia: Final Report of a 52-Week, Multicenter Postmarketing Surveillance Study. Toxins (Basel). 2023 Sep 5;15(9):553. doi: 10.3390/toxins15090553.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Dysphonia, run by GlaxoSmithKline at 1 site in Japan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Oct 2021. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse drug reactions (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543150, which also lists 1 linked publication.
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 7 Oct 2021.