An observational study in Dysphonia, sponsored by GlaxoSmithKline. Status unknown at 1 site in Japan. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by GlaxoSmithKline · Observational
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.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's planned enrollment of 400 is above the median of 123 across 40 observational studies indexed under Dysphonia.
Browse Dysphonia studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
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Subjects receiving BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study.
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Exclusion Criteria:
Subjects with a diagnosis of spasmodic dysphonia, for which BOTOX is indicated, will be included.
Drug: BOTOX
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
No publications or documents are linked to this record.
Started Jul 2018 (actual). Primary completion is estimated for Feb 2022, 43 months after the start.
Of 18 observational studies under Dysphonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 193. This study's planned 43 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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