PBASE-system Acute Migraine Clinical Investigation

This study has been terminated.
(Too slow recruitment rate)
Sponsor:
Information provided by (Responsible Party):
Rhinomed AB
ClinicalTrials.gov Identifier:
NCT01680029
First received: September 3, 2012
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Acute Migraine
Device: PBASE-system 2.0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rhinomed AB:

Primary Outcome Measures:
  • Headache relief [ Time Frame: 2 hours post-initiation of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2013
Arms Assigned Interventions
Experimental: PBASE-system 2.0 Device: PBASE-system 2.0

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680029

Locations
United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Stoke-on-trent, United Kingdom
Sponsors and Collaborators
Rhinomed AB
  More Information

No publications provided

Responsible Party: Rhinomed AB
ClinicalTrials.gov Identifier: NCT01680029     History of Changes
Other Study ID Numbers: PM001
Study First Received: September 3, 2012
Last Updated: November 8, 2013
Health Authority: United Kingdom: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014