An observational study in Primary Headache Disorders, sponsored by VR1 Corporation. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-28.
Sponsored by VR1 Corporation · Observational
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.
42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.
This study's enrollment of 20 is below the median of 120 across 21 observational studies indexed under Headache Disorders, Primary.
Browse Headache Disorders, Primary studies →This is the only study on the registry with VR1 Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients in a Clinical headache practice (outpatient) with a diagnosis of a primary headache disorder.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with Primary Headache disorders will receive Ausanil in the context of usual and routine clinical care.
Also known as: capsicum annuum
Incidence of Adverse Events (all cause)
Patient/Physician reporting
Time frame: 8 weeks
Incidence of Adverse Events causally related to Ausanil
Patient/Physician reporting
Time frame: 8 weeks
Serious Adverse Events
Patient/Physician reporting
Time frame: 8 weeks
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
Time frame: 24 hours
Functional Assessment
Improvement in ability to function after Headache treatment
Time frame: 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)
Time frame: 24 hours
Time Loss to headache
How many hours of function were lost as result of the headache?
Time frame: 24 hours
Use of Rescue Medication
Frequency of Rescue medication will be tabulated
Time frame: 24 hours
Sting severity and duration
How long does the sting associated with Ausanil treatment last?
Time frame: one hour
The record gives a start of Feb 2015, a primary completion of Dec 2016 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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