A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil
Stopped early
Conditions studied: Primary Headache Disorders
In brief
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.
Key facts
- Study ID
- NCT02392273
- Run by
- VR1 Corporation
- People needed
- 20
- Starts
- 2015-02-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2016-12-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Atlantic Health System/Overlook Medical Center Medical Arts Center — Summit, New Jersey, United States
Full record on ClinicalTrials.gov
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