A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

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.

Study Overview

• Status: Terminated
• Conditions: Primary Headache Disorders
• Intervention / Treatment: Drug: Ausanil

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Atlantic Health System/Overlook Medical Center Medical Arts Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in a Clinical headache practice (outpatient) with a diagnosis of a primary headache disorder.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (all cause)	Patient/Physician reporting	8 weeks
Incidence of Adverse Events causally related to Ausanil	Patient/Physician reporting	8 weeks
Serious Adverse Events	Patient/Physician reporting	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours
Functional Assessment	Improvement in ability to function after Headache treatment	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)	24 hours
Time Loss to headache	How many hours of function were lost as result of the headache?	24 hours
Use of Rescue Medication	Frequency of Rescue medication will be tabulated	24 hours
Sting severity and duration	How long does the sting associated with Ausanil treatment last?	one hour

Collaborators and Investigators

• Sponsor: VR1 Corporation
• Investigators: Principal Investigator: Seth Stoller, MD, Atlantic Health System

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Estimate): December 28, 2016
• Last Update Submitted That Met QC Criteria: December 23, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: migraine; cluster headache; primary headache; Ausanil; capsicum annuum
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders; Headache Disorders, Primary
• Other Study ID Numbers: Ausanil Study 001