Occipital Nerve Stimulation in the Treatment of Migraine

NCT01855672 | Terminated Phase 1

• 1 other identifier: ESC-13-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this proof-of-concept study is to generate initial safety and effectiveness data for the neuro-modulation stimulation (NMS) E-Box in patients with chronic migraine in an acute setting. The results of this study will determine if further development of this device in a larger study is warranted.

Conditions

Migraine

Keywords

Migraine, occipital nerve, stimulation

Outcome Measures

Primary Outcomes (1)

• Reduction of Head Pain Severity

  The primary endpoint is overall reduction of head pain severity in subjects with chronic migraine who are treated with the NMS E-Box over a 96-hour treatment period.

  Over 96-hours treatment period

Secondary Outcomes (11)

• Rates of Reduction in Severity of Head Pain

  Over the 96-hour treatment period

• Time with No Head Pain

  Over the 96-hour Treatment Period

• Presence of Symptoms

  Over the 96-hour treatment period

• Severity of Symptoms

  Over the 96-hour treatment period

• Use of Medication

  Over the 96-hour treatment period

Other Outcomes (1)

• Safety

  Over the treatment and follow-up periods

Study Arms (2)

Perceivable Stimulation

ACTIVE COMPARATOR

Stimulation of the occipital nerves.

Device: Stimulation of the Occipital Nerves

Non-Perceivable

ACTIVE COMPARATOR

Stimulation of the occipital nerves.

Device: Stimulation of the Occipital Nerves

Interventions

Stimulation of the Occipital Nerves DEVICE

Electrical stimulation of the occipital nerves.

Non-Perceivable; Perceivable Stimulation

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥ 18 and ≤ 65 years of age females or males;
• Willing to participate in the study and to complete all study-related procedures, evaluations, and headache diaries;
• Able to understand, agree to, and sign the study's IRB-approved informed consent form;
• Has a physician-made diagnosis of Chronic Migraine as defined by the following (a, b, and c):
• Headache (tension-type and/or migraine) lasting a minimum of 4 hours on ≥15 days per month for at least 3 months and on ≥XX (redacted by sponsor to preserve integrity of study) days in the 30 days prior to the Screening Visit;
• Headaches on ≥8 days per month for at least 3 months that have fulfilled the following:
• i. Headaches with at least two of the following:
• unilateral location;
• pulsating quality;
• moderate or severe pain intensity;
• aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs);
• ii. AND at least one of the following:
• nausea and/or vomiting;
• photophobia and phonophobia;
• iii. OR headaches that have been treated and relieved by triptan(s) or ergot before the expected development of the symptoms listed in 4.b.i and 4.b.ii above;

You may not qualify if:

• Any condition that could affect the subject's ability to assess the effect of neurostimulation or in which neurostimulation may be a safety concern, including but not limited to:
• Known history of epilepsy or recurrent seizures;
• Known neurogenic and neuromuscular disorders (i.e. myasthenia gravis, multiple sclerosis, autonomic disorders);
• Uncontrolled diabetes mellitus;
• Known peripheral neuropathy;
• History of taking the following medications in the 30 days prior to the Screening Visit:
• Opioid and opioid-containing medications;
• Butalbital, butalbital-containing, and barbiturate medications;
• Systemic corticosteroids (exceptions: acute corticosteroid medication including inhaled therapy (pulmonary), ocular therapy, or non-spinal intra-articular therapy);
• Urine drug screen that is positive for any of the tested drugs (i.e., cannabis, opiates, barbiturates, amphetamines , benzodiazepines and cocaine) at the Screening Visit (Visit 1) and the Inpatient Treatment Eligibility Visit (Visit 2);
• Positive pregnancy test at the Screening Visit (Visit 1) or at the Inpatient Treatment Eligibility Visit (Visit 2);
• Known history of cardiac conduction or heart rate abnormalities associated with symptoms;
• Uncontrolled hypertension;
• Any tattoos or extensive tissue scarring in the cervical/occipital area;
• Any active skin lesions, skin damage, broken skin, history of easy bruising or bleeding disorders, or history of surgery and/or trauma in the cervical/occipital area at the time of the Screening Visit;

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (4)

ActivMed

Newington, New Hampshire, United States

Location

Clinilabs

New York, New York, United States

Location

Community Research

Cincinnati, Ohio, United States

Location

TJU

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• David Biondi, DO

  Janssen, LP

  STUDY DIRECTOR

• Jeff Hammond, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 16, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 17, 2013

Record last verified: 2013-06

Locations

US (4)