A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil
- Conditions
- Primary Headache Disorders
- Registration Number
- NCT02392273
- Lead Sponsor
- VR1 Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (all cause) 8 weeks Patient/Physician reporting
Incidence of Adverse Events causally related to Ausanil 8 weeks Patient/Physician reporting
Serious Adverse Events 8 weeks Patient/Physician reporting
- Secondary Outcome Measures
Name Time Method Sting severity and duration one hour How long does the sting associated with Ausanil treatment last?
Headache Response to Ausanil 24 hours Change in Headache severity on a four point scale (0-3) will be measured at 5 minutes, one hour, two hours and twenty four hours
Functional Assessment 24 Hours Improvement in ability to function after Headache treatment
Patient satisfaction for Treatment 24 hours Patients will be asked to rate their satisfaction with treatment on a 7 point scale (very dissatisfied to very satisfied)
Time Loss to headache 24 hours How many hours of function were lost as result of the headache?
Use of Rescue Medication 24 hours Frequency of Rescue medication will be tabulated
Trial Locations
- Locations (1)
Atlantic Health System/Overlook Medical Center Medical Arts Center
🇺🇸Summit, New Jersey, United States