A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:4/2/2016
Start Date:February 2015
End Date:April 2016
Contact:Seth Stoller, MD
Email:seth.stoller@atlantichealth.org
Phone:9085222709

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Trial Summary
Trial Overview
Inclusion Criteria
This study is an observational study with the primary objective to assess the safety and
tolerability of Ausanil in the treatment of primary headache disorders. The secondary
objective is to assess headache pain, functional outcome, time loss to headache and patient
satisfaction with Ausanil treatment.


Inclusion Criteria:

- Men and women aged 18 to 80 years

- Primary Headache disorder as per International Classification of Headache
Disorders-11

- Ausanil naive

- Signed dated informed consent

- Females of childbearing potential must be using adequate contraception during study
period.

- Willing and able to comply with registry requirements to document headache response

Exclusion Criteria:

- Known allergy to Ausanil or any of its ingredients

- Active bronchial asthma that in the opinion of the investigator would interfere with
use of Ausanil

- Nasal obstruction due to any cause or extensive nasal surgery resulting in scarring
or other such impact on nasal mucosa that might lead to heightened sensitivity to
Ausanil in the opinion of the investigator.

- Pregnant or breast feeding females

- History of addictive behavior

- Any severe or chronic unstable medical or psychiatric condition

- Active nasal infection or inflammation

- Unable or unwilling to provide informed consent

- Suffer from atypical, basilar or hemiplegic migraine that is new onset or unstable.
We found this trial at
1
site
Atlantic Health System/Overlook Medical Center Medical Arts Center
Summit, New Jersey 07901
?
mi
from
Summit, NJ
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