NCT02392273
Terminated
Not Applicable
A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil
ConditionsPrimary Headache Disorders
DrugsAusanil
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Headache Disorders
- Sponsor
- VR1 Corporation
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events (all cause)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Incidence of Adverse Events (all cause)
Time Frame: 8 weeks
Patient/Physician reporting
Incidence of Adverse Events causally related to Ausanil
Time Frame: 8 weeks
Patient/Physician reporting
Serious Adverse Events
Time Frame: 8 weeks
Patient/Physician reporting
Secondary Outcomes
- Headache Response to Ausanil(24 hours)
- Functional Assessment(24 Hours)
- Patient satisfaction for Treatment(24 hours)
- Time Loss to headache(24 hours)
- Use of Rescue Medication(24 hours)
- Sting severity and duration(one hour)
Study Sites (1)
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