A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

VR1 Corporation

Status: Terminated

Conditions: Primary Headache Disorders

Treatments: Drug: Ausanil

Study type: Observational

Funder types: Industry

Identifiers

NCT02392273

Ausanil Study 001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.