Clinical Trial: A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

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.

Detailed Summary:
Sponsor: VR1 Corporation

Current Primary Outcome:

• 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

Original Primary Outcome:

• Incidence of Adverse Events (all cause) [ Time Frame: 8 weeks ]
• Incidence of Adverse Events causally related to Ausanil [ Time Frame: 8 weeks ]
• Serious Adverse Events [ Time Frame: 8 weeks ]

Current Secondary Outcome:

• Headache Response to Ausanil [ Time Frame: 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
• Functional Assessment [ Time Frame: 24 Hours ]
  Improvement in ability to function after Headache treatment
• Patient satisfaction for Treatment [ Time Frame: 24 hours ]
  Patients will be asked to rate their satisfaction with treatment on a 7 point scale (very dissatisfied to very satisfied)
• Time Loss to headache [ Time Frame: 24 hours ]
  How many hours of function were lost as result of the headache?
• Use of Rescue Medication [ Time Frame: 24 hours ]
  Frequency of Rescue medication will be tabulated
• Sting severity and duration [ Time Frame: one hour ]
  How long does the sting associated with Ausanil treatment last?

Original Secondary Outcome:

• Headache Response to Ausanil [ Time Frame: 24 hours ]
• Functional Assessment [ Time Frame: 24 Hours ]
  Improvement in ability to function after Headache treatment
• Patient satisfaction for Treatment [ Time Frame: 24 hours ]
• Time Loss to headache [ Time Frame: 24 hours ]
  How many hours of function were lost as result of the headache?
• Use of Rescue Medication [ Time Frame: 24 hours ]
• Sting severity and duration [ Time Frame: one hour ]
  How long does the sting associated with Ausanil treatment last?

Information By: VR1 Corporation

Dates:
Date Received: March 12, 2015
Date Started: February 2015
Date Completion: January 2017
Last Updated: December 23, 2016
Last Verified: December 2016