Incobotulinium toxin A group for Tetanus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tetanusincobotulinum toxin A - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Tinnitus is a persistent non-physiologic, non-psychiatric, ringing in the ear that affects up to 20% of the general US population. The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of tinnitus with use of the Tinnitus Handicap Inventory questionnaire.

Eligible Conditions
  • Tetanus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: pre-injection baseline to 4-6 weeks post injection

Week 6
Change in the Tinnitus Handicap Inventory score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Incobotulinium toxin A group
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

33 Total Participants · 2 Treatment Groups

Primary Treatment: Incobotulinium toxin A group · Has Placebo Group · Phase 2

Incobotulinium toxin A group
Drug
Experimental Group · 1 Intervention: incobotulinum toxin A · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo-Saline · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pre-injection baseline to 4-6 weeks post injection

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,255 Previous Clinical Trials
1,483,865 Total Patients Enrolled
Stephanie Standal, MDPrincipal InvestigatorUniversity of Minnesota

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are aged 18 years or older.
You have tinnitus in one or both ears for at least two months.
Your Tinnitus Handicap Inventory score is above 16, indicating a higher level of suffering from tinnitus.
You must be able and willing to provide knowledgeable consent.

Who else is applying?

What state do they live in?
Minnesota50.0%
Pennsylvania50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
050.0%
3+50.0%
Why did patients apply to this trial?
  • "It has been affecting my daily life and would like to try to find something that will help."