A Prospective Observational Registry of Primary Headache... | NCT02392273

Studies
A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

NCT02392273

Sponsor

VR1 Corporation

Status

Terminated

Last Update Posted

Dec 28, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Primary Headache Disorders

Interventions

Ausanil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study unable to recruit

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Mar 12, 2015

First Submission Date that Met QC Criteria

Mar 12, 2015

First Posted Date

Mar 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2016

Last Update Posted Date

Dec 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ausanil	Drug	Patients with Primary Headache disorders will receive Ausanil in the context of usual and routine clinical care.		capsicum annuum

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seth Stoller, MD	Atlantic Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atlantic Health System/Overlook Medical Center Medical Arts Center		Summit	New Jersey	07901	United States

Condition Browse Module

MeSH Terms

ID	Term
D051270	Headache Disorders, Primary
D008881	Migraine Disorders
D003027	Cluster Headache

Ancestor Terms

ID	Term
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided