Overview

This trial is active, not recruiting.

Condition migraine disorders
Treatment occipital nerve stimulator
Sponsor Boston Scientific Corporation
Start date January 2013
End date September 2016
Trial size 180 participants
Trial identifier NCT01775735, CDM00046436, G120051

Summary

The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
The treatment device is an occipital nerve stimulator, specifically the BSC Precision™ ONS System
occipital nerve stimulator Boston Scientific Precision System
Electrical stimulation of the greater occipital nerve
(Active Comparator)
The treatment device is on occipital nerve stimulator, specifically the BSC Precision™ ONS System
occipital nerve stimulator Boston Scientific Precision System
Electrical stimulation of the greater occipital nerve

Primary Outcomes

Measure
Change in the number of moderate-to-severe headache days per month
time frame: from Baseline to 6 months post-randomization

Secondary Outcomes

Measure
Moderate-to-severe headache frequency response
time frame: 6 months post-randomization
Conversion to <15 moderate-to-severe headache days per month
time frame: 6 months post-randomization
Change in average number of moderate-to-severe headache hours per day
time frame: from Baseline to 6 months post-randomization
Change in daily headache intensity
time frame: from Baseline to 6 months post-randomization
Headache intensity response (30%)
time frame: 6 months post-randomization
Change in headache impact
time frame: from Baseline to 6 months post-randomization
Change in migraine-specific quality of life
time frame: from Baseline to 6 months post-randomization
Subject satisfaction with treatment
time frame: 6 months post-randomization
Rate of adverse events (AEs)
time frame: 6 months post-randomization

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

Key Inclusion Criteria: - Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history - Evidence of intractability - Posterior-dominant head pain - Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening - Onset of migraine before the age of 50 - If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test Key Exclusion Criteria: - Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia) - Untreated panic disorder - Untreated major depression evidenced by a PHQ-9 score >20 - Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15 - Currently diagnosed with severe personality disorder - A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception - Participating in another drug, device, or biologics trial within 3 months prior to Screening - A terminal illness associated with survival <24 months

Additional Information

Official title Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
Principal investigator Richard Lipton, MD
Description Initial reports of managing migraine headache with ONS described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. The leads were tunneled under the skin to an implantable pulse generator (IPG) implanted in the chest wall or abdomen. The OPTIMISE Trial is designed to be a pivotal study of the Boston Scientific PRECISION neurostimulation system, when the system is used for ONS. The PRECISION System has been previously been approved for Spinal Cord Stimulation (SCS).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.