TerminatedPhase 1/2

Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome

Stopped: Lead investigator moved to a new medical center; study was stopped when he left.

United States9 participantsStarted 2008-12

Plain-language summary

Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable distress. To date there is no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or simply use of cotton wads/ silicon cones to simulate the resistive action to airflow of the resected turbinates. This study will research the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of botulinum toxin type A (Botox).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has no known allergies to Botox. Exclusion Criteria: * Patients younger than 18 years or older than 65 years of age. * Patients with neuromuscular disorders or neuropathic diseases. * Patients with infection and or swelling at the site where Botox is to be injected. * Patients with known hypersensitivity to any ingredient in the drug formulation (botulinum toxin, human albumin) * Patients who are or plan to become pregnant within the time period in which the study will be conducted. * Patients who are nursing

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)

Timeframe: 2 weeks after intervention, 2 months

Trial details

NCT IDNCT00732680

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2013-11-13

View on ClinicalTrials.gov More Empty Nose Syndrome trials