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

September 3, 2012
November 8, 2013
January 2013
Not Provided
Headache relief [ Time Frame: 2 hours post-initiation of treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01680029 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PBASE-system Acute Migraine Clinical Investigation
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Migraine
Device: PBASE-system 2.0
Experimental: PBASE-system 2.0
Intervention: Device: PBASE-system 2.0
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
Not Provided
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01680029
PM001
No
Rhinomed AB
Rhinomed AB
Not Provided
Not Provided
Rhinomed AB
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP