A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

Primary Headache Disorders Clinical Trial

Official title:

A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02392273
• Other study ID #: Ausanil Study 001
• Status: Terminated
• Phase: N/A
• First received: March 12, 2015
• Last updated: December 23, 2016
• Start date: February 2015
• Est. completion date: January 2017

Study information

• Verified date: December 2016
• Source: VR1 Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Primary Headache Disorders

Intervention

Drug:
• Ausanil
Patients with Primary Headache disorders will receive Ausanil in the context of usual and routine clinical care.

Locations

Country	Name	City	State
United States	Atlantic Health System/Overlook Medical Center Medical Arts Center	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
VR1 Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (all cause)	Patient/Physician reporting	8 weeks	Yes
Primary	Incidence of Adverse Events causally related to Ausanil	Patient/Physician reporting	8 weeks	Yes
Primary	Serious Adverse Events	Patient/Physician reporting	8 weeks	Yes
Secondary	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	No
Secondary	Functional Assessment	Improvement in ability to function after Headache treatment	24 Hours	No
Secondary	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	No
Secondary	Time Loss to headache	How many hours of function were lost as result of the headache?	24 hours	No
Secondary	Use of Rescue Medication	Frequency of Rescue medication will be tabulated	24 hours	No
Secondary	Sting severity and duration	How long does the sting associated with Ausanil treatment last?	one hour	No