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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sorlandsklinikken

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

19 Aug 2025 → ongoing

Decision date (initial)

2025-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Praktiserende Spesialisters Landsforening

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The present study aims to explore the possible effects of injections with BoNTA on tinnitus in patients with concurrent bruxism and/or jaw muscle myalgia

Secondary objectives 3

1. To determine if treatment with BoNTA injections lessen headache in patients with tinnitus
2. To determine if treatment with BoNTA injections lessen jaw muscle pain in patients with tinnitus.
3. To determine if treatment with BoNTA injections improve Quality of Life (QoL) in patients with tinnitus

Conditions and MedDRA coding

Tinnitus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Participant must be 18 years or older. • Participant has had tinnitus in one or both ears present for more than three months. • Participant has a THI score at screening > 40. • Participant’s hearing was assessed as normal by audiometry. • Participant presents with severe bruxism as assessed by a neurologist and where other treatments have been insufficient to alleviate symptoms. • VAS score for headache ≥1 • VAS score for jaw muscle pain ≥1 • Participant can understand and complete the forms (THI and QoL-EQ-5D-5L) in the Norwegian language. • In case of women of childbearing potential (WOCBP) they have to be using highly effective contraception (for more details refer to appendix 10.3.1). • Signed written informed consent.

Exclusion criteria 1

1. Participants are excluded from the study if any of the following criteria apply: 1. Participant exhibits pulsatile tinnitus. 2. Participant shows evidence of middle ear disease, chronic middle ear, or mastoid infection assessed by an ENT specialist. 3. Active infection at the sites of injection. 4. Participant has a severe somatic illness or psychiatric disorder that would make the individual unable to comply and participate in the study. 5. Participant has any medical condition that may put the patient at increased risk of exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, Amyotrophic lateral sclerosis, other diseases interfering with neuromuscular function (Felleskatalogen, 2024) or treatment with drugs affecting the neuromuscular junction. 6. Participant has hemophilia or other clotting disorders that cause bleeding diathesis. 7. Participant has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that has been active or required treatment in the past 6 months. 8. Females who are breastfeeding, pregnant, or unwilling to practice adequate contraception throughout the study 9. Participant received treatment with botulinum toxin of any serotype within six months before randomization. 10. Participant has a known allergy to BoNTA. 11. Participant has been immunized for any botulinum toxin serotype. 12. Abuse of alcohol or illicit drugs. 13. Participant has any condition or situation that, in the investigator’s opinion, puts them at significant risk, could confound the study results, and may interfere significantly with the patient’s participation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sorlandsklinikken

Sponsor organisation

Sorlandsklinikken

Address

Stoaveien 9

City

Arendal

Postcode

4848

Country

Norway

Scientific contact point

Organisation

Sorlandsklinikken

Contact name

Karen Herlofson

Public contact point

Organisation

Sorlandsklinikken

Contact name

Karen Herlofson

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications