An observational study in Primary Headache Disorders, sponsored by VR1 Corporation. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-28.
Sponsored by VR1 Corporation · Observational
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.
Patients in a Clinical headache practice (outpatient) with a diagnosis of a primary headache disorder.
Exclusion Criteria:
Patients with Primary Headache disorders will receive Ausanil in the context of usual and routine clinical care.
Also known as: capsicum annuum
Incidence of Adverse Events (all cause)
Patient/Physician reporting
Time frame: 8 weeks
Incidence of Adverse Events causally related to Ausanil
Patient/Physician reporting
Time frame: 8 weeks
Serious Adverse Events
Patient/Physician reporting
Time frame: 8 weeks
Headache Response to Ausanil
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
Time frame: 24 hours
Functional Assessment
Improvement in ability to function after Headache treatment
Time frame: 24 Hours
Patient satisfaction for Treatment
Patients will be asked to rate their satisfaction with treatment on a 7 point scale (very dissatisfied to very satisfied)
Time frame: 24 hours
Time Loss to headache
How many hours of function were lost as result of the headache?
Time frame: 24 hours
Use of Rescue Medication
Frequency of Rescue medication will be tabulated
Time frame: 24 hours
Sting severity and duration
How long does the sting associated with Ausanil treatment last?
Time frame: one hour
This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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