Authorised Therapeutic confirmatory (Phase III) Tinnitus

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

EU CTIS ID: 2024-518256-23-00

What this study is testing

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

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • • 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.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.