Study of Occipital Nerve Stimulation for Drug Refractory Migraine

NCT00747812 | Terminated Phase 2 Results

• 1 other identifier: PRISM-UK-05
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.

Conditions

Migraine

Keywords

Headache; Migraine; Refractory; Chronic; Pain

Outcome Measures

Primary Outcomes (2)

• Number of Hours of Headache

  12 weeks

• Number of Days With 4 or More Hours of Headache

  12 Weeks

Study Arms (2)

1

EXPERIMENTAL

Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.

Device: Precision

2

SHAM COMPARATOR

Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.

Device: Precision

Interventions

Precision DEVICE

Implantable Neurostimulator

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 fo 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.

You may not qualify if:

• Have onset of headache after age 50;
• Are current substance abusers (including alcohol and illicit drugs);
• Have a significant psychiatric disorder;
• Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant);
• Have had nerve stimulation for pain relief.
• 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 radiofrequency procedure currently in effect.
• Have a condition currently requiring or likely to require the use of MRI or diathermy;
• Have an active implantable device;
• Are pregnant or lactating or planning to become pregnant in the next 14 months;
• Have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Royal Free Hospital - Dept of Clinical Neurosciences

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Bronchiolitis Obliterans Syndrome; Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Limitations and Caveats

Insufficient data collected from limited number of implanted subjects.

Results Point of Contact

• Title: Lyn Pimentel, Clinical Project Manager
• Organization: Boston Scientific

Lyn.Pimentel@bsci.com

(661) 949-4174

Study Officials

• Peter J. Goadsby, MD

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: May 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2012
• Last Updated: November 27, 2020
• Results First Posted: August 3, 2012

Record last verified: 2020-11

Locations

GB (1)