Treatment for Migraines With an Implantable Device

• ClinicalTrials.gov Identifier: NCT00286078
• Recruitment Status: Completed
• First Posted: February 3, 2006
• Results First Posted: August 9, 2016
• Last Update Posted: July 30, 2019
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Tracking Information

• First Submitted Date: February 1, 2006
• First Posted Date: February 3, 2006
• Results First Submitted Date: April 6, 2016
• Results First Posted Date: August 9, 2016
• Last Update Posted Date: July 30, 2019
• Study Start Date: February 2006
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 28, 2016)

• Migraine Frequency at 12 Weeks [ Time Frame: Baseline and 12 weeks ]
  Change from baseline in migraine days/month at 12 weeks
• Frequency of Adverse Event [ Time Frame: 26 weeks ]
  Cumulative frequency of adverse events from randomization to 26 weeks

Original Primary Outcome Measures (submitted: February 1, 2006)

• Migraine Frequency at 12 Weeks
• Frequency of Adverse Event throughout the study.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: February 1, 2006)

• Migraine Frequency at 26, 40, and 52 weeks
• Medication use at 12, 26, 40, and 52 weeks
• Headache Frequency at 12, 26, 40, and 52 weeks
• Cost-effectiveness, Quality of Life, Disability, and Productivity at 12, 26, 40, and 52 weeks.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment for Migraines With an Implantable Device
• Official Title: Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
• Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of an implantable device for difficult to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Migraine

Intervention

Device: Precision

Implantable neurostimulator

Study Arms

• Experimental: Treatment
  Active occipital nerve stimulation (stimulation on)
  Intervention: Device: Precision
• Sham Comparator: Control
  Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
  Intervention: Device: Precision

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 5, 2007): 179
• Original Enrollment (submitted: February 1, 2006): 180
• Actual Study Completion Date: November 7, 2018
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Be diagnosed with multiple migraines per month of moderate to severe intensity;
• Be refractory to medication;
• Be an appropriate candidate for the surgical procedures required for this study;
• Be willing and able to comply with all study related procedures;
• Be capable of reading and understanding patient information materials and giving written informed consent.

Key Exclusion Criteria:

• Have onset of migraine after age 50;
• Have a significant psychiatric disorder;
• Have previously been treated with occipital nerve stimulation;
• Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
• Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radio frequency procedure currently in effect;
• Have a condition currently requiring or likely to require the use of MRI or diathermy;
• Have an active implantable device;
• Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00286078
• Other Study ID Numbers: EI0105
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Boston Scientific Corporation
• Study Sponsor: Boston Scientific Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Richard Lipton, MD; Albert Einstein College of Medicine

• PRS Account: Boston Scientific Corporation
• Verification Date: July 2019