Primary Headache Disorders
Conditions
Keywords
migraine, cluster headache, primary headache, Ausanil, capsicum annuum
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.
Interventions
DRUGAusanil
Patients with Primary Headache disorders will receive Ausanil in the context of usual and routine clinical care.
Sponsors
VR1 Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time Loss to headache | 24 hours | How many hours of function were lost as result of the headache? |
| 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 |
| Sting severity and duration | one hour | How long does the sting associated with Ausanil treatment last? |
| Use of Rescue Medication | 24 hours | Frequency of Rescue medication will be tabulated |
| 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) |
Countries
United States
Outcome results
None listed