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TINNITOX - Botulinum toxin A in tinnitus patients with concurrent bruxism and/or jaw muscle myalgia. A triple blind, randomized, placebo-controlled cross-over trial.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518256-23-00
Acronym
Tinnitox
Enrollment
100
Registered
2025-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Brief summary

Difference in change of the Tinnitus Handicap Inventory (THI) score from baseline to week 18 between the active treatment and the placebo

Detailed description

Difference in change of headache score using the Visual Analog Scale (VAS) from baseline to week 18 between the active treatment and the placebo, Difference in change of jaw muscle pain score using the VAS from baseline to week 18 between the active treatment and the placebo, Difference in change of QoL score using EQ-5D-5L questionnaire from baseline to week 18 between the active treatment and the placebo

Interventions

Sponsors

Sorlandsklinikken
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Difference in change of the Tinnitus Handicap Inventory (THI) score from baseline to week 18 between the active treatment and the placebo

Secondary

MeasureTime frame
Difference in change of headache score using the Visual Analog Scale (VAS) from baseline to week 18 between the active treatment and the placebo, Difference in change of jaw muscle pain score using the VAS from baseline to week 18 between the active treatment and the placebo, Difference in change of QoL score using EQ-5D-5L questionnaire from baseline to week 18 between the active treatment and the placebo

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026