PBASE-system Acute Migraine Clinical Investigation

November 8, 2013 updated by: Chordate Medical

A Clinical Investigation to Evaluate the Safety and Performance of the PBASE-system When Used in the Treatment of Acute Migraine Episodes of Moderate to Severe Intensity

To evaluate the performance and safety of the PBASE-system when used in the treatment of acute migraine episodes of moderate to severe intensity. The study will evaluate the effect of treatment on migraine pain and symptoms during an acute attack and also any long-term effect.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
      • Stoke-on-trent, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to provide written informed consent prior to participation in the clinical investigation
  • Male or female aged between 18 and 65 years
  • Diagnosed as suffering from migraine with or without aura according to IHS classification (ICHD-II)
  • Reported history of 2 to 6 migraine episodes per month during previous 3 months, confirmed during a prospective baseline period of one month
  • Reported history of no less than 50% of migraine episodes involving moderate or severe pain intensity, confirmed during a prospective baseline period of one month
  • Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during a prospective baseline period of one month
  • Reported history of the majority of untreated migraine attack durations lasting 8 hours or more
  • Onset of migraine headache occured before age 50
  • Reported history of migraine for more than one year
  • Able and willing to maintain current preventive headache medication regimen(s) (no change in type, frequency or dose) from baseline screening visit to 2 weeks post-treatment
  • Able to understand and complete the electronic diary
  • Experiencing an acute migraine attack of moderate to severe pain intensity at the time of treatment
  • Treatment is possible within 5 hours of migraine onset

Exclusion Criteria:

  • Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during a prospective baseline period of one month
  • Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during a prospective baseline period of one month
  • Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack
  • Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visit
  • Previously treated with an implantable stimulator or any implantable devices in the head and/or neck
  • Diagnosed as having a pronounced anterior septal deviation
  • History of sinus surgery, transphenoidal surgery for pituitary or other lesions or CSF rhinorrhea
  • Fitted with a pacemaker /defibrillator
  • Previously treated with radiation to the face
  • Ongoing bacterial infection in the nasal cavity
  • History of nose bleeds (epistaxis)
  • Ongoing malignancy in the nasal cavity
  • Concomitant condition that could cause excessive bleeding
  • Known allergy to polyvinylchloride,the material used for fabrication of the balloon part of Catheter A100, or medicinal liquid paraffin
  • Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation
  • Any change in migraine prophylaxis between the screening and treatment visit
  • Women of childbearing potential who is pregnant or at risk of becoming pregnant prior to or during the treatment phase
  • Participation in a clinical research study within 3 months of enrolment or planned participation at any time during this clinical investigation
  • Considered to meet the definition of vulnerable in the Investigator's opinion
  • Headache or migraine episode within the 48 hours prior to treatment
  • PRN (as required) or acute migraine medication(s) taken within the 48 hours prior to treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PBASE-system 2.0
Device: PBASE-system 2.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Headache relief
Time Frame: 2 hours post-initiation of treatment
2 hours post-initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chordate Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

September 3, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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