BOTULINUM TOXIN TYPE A for Tinnitus|Bruxism|Jaw muscle myalgia

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- 1.\tParticipant exhibits pulsatile tinnitus."}
• {"criterion_text":"- 2.\tParticipant shows evidence of middle ear disease, chronic middle ear, or mastoid infection assessed by an ENT specialist."}
• {"criterion_text":"- 3.\tActive infection at the sites of injection."}
• {"criterion_text":"- 4.\tParticipant has a severe somatic illness or psychiatric disorder that would make the individual unable to comply and participate in the study."}
• {"criterion_text":"- 5.\tParticipant 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."}
• {"criterion_text":"- 6.\tParticipant has hemophilia or other clotting disorders that cause bleeding diathesis."}
• {"criterion_text":"- 7.\tParticipant 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."}
• {"criterion_text":"- 8.\tFemales who are breastfeeding, pregnant, or unwilling to practice adequate contraception throughout the study"}
• {"criterion_text":"- 9.\tParticipant received treatment with botulinum toxin of any serotype within six months before randomization."}
• {"criterion_text":"- 10.\tParticipant has a known allergy to BoNTA."}
• {"criterion_text":"- 11.\tParticipant has been immunized for any botulinum toxin serotype."}
• {"criterion_text":"- 12.\tAbuse of alcohol or illicit drugs."}
• {"criterion_text":"- 13.\tParticipant 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."}

Primary endpoints

• {"endpoint_text":"- Difference in change of the Tinnitus Handicap Inventory (THI) score from baseline to week 18 between the active treatment and the placebo","definition_or_measurement_approach":"Change in Tinnitus Handicap Inventory (THI) score from baseline to week 18; comparison of difference in change between active treatment (BoNTA) and placebo."}

Secondary endpoints

• {"endpoint_text":"- Difference in change of headache score using the Visual Analog Scale (VAS) from baseline to week 18 between the active treatment and the placebo","definition_or_measurement_approach":"Change in headache score measured by Visual Analog Scale (VAS) from baseline to week 18; comparison between active and placebo."}
• {"endpoint_text":"- Difference in change of jaw muscle pain score using the VAS from baseline to week 18 between the active treatment and the placebo","definition_or_measurement_approach":"Change in jaw muscle pain measured by Visual Analog Scale (VAS) from baseline to week 18; comparison between active and placebo."}
• {"endpoint_text":"- Difference in change of QoL score using EQ-5D-5L questionnaire from baseline to week 18 between the active treatment and the placebo","definition_or_measurement_approach":"Change in quality of life measured by EQ-5D-5L from baseline to week 18; comparison between active and placebo."}

Norway

Earliest CTIS Part Ii Submission Date

29-04-2025

Latest Decision Or Authorization Date

30-04-2025

Processing Time Days

1

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Sorlandsklinikken

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway