Vagus Nerve Stimulation in Crohn's Disease

NCT02311660 | Unknown

• 1 other identifier: SPM-007
• Study Type: interventional
• Target: 15
• Locations: 4 countries
• Sites: 4

Brief Summary

This is an open label interventional study using an implantable vagus nerve stimulation device in patients with Crohn's disease who have active disease despite treatment with a tumor necrosis factor (TNF) antagonist drug.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Crohn's Disease Activity Index

  Week 16

Secondary Outcomes (7)

• Simple Endoscopic Score for Crohn's Disease (SES-CD)

  Week 16

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  Week 16

• Heart Rate Variability (HRV)

  Week 16

• Changes in Whole Blood Lipopolysaccharide-Induced TNF Release Assay

  Week 16

• Serum Inflammation Mediators using Meso Scale Discovery Inflammation Multiplex Assay

  Week 16

Study Arms (1)

vagus nerve stimulation

EXPERIMENTAL

Patients will have an implanted vagus nerve stimulation device.

Device: Vagus Nerve Stimulation Device

Interventions

Vagus Nerve Stimulation Device DEVICE

Cyberonics VNS System

vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18-75 years, inclusive
• Written informed consent prior to any of the screening procedures
• Diagnosis of Crohn's disease for more than 4 months prior to Week -4 Visit, with small bowel and/or colonic involvement
• Current evidence of moderately-to-severely active disease defined by a Week -4 Visit Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive
• Simple Endoscopic Score for Crohn's Disease evaluation at baseline showing presence of a minimal ulcer score of 2 or 3 in at least 1 segment
• Levels of fecal calprotectin greater than or equal to 200 microgram/gram feces at Week -4 Visit
• History of inadequate response and/or intolerance or adverse events leading to discontinuation of one or more TNF-alpha inhibitors (e.g., infliximab, adalimumab, or certolizumab pegol), or vedolizumab
• Female subjects of child-bearing potential are eligible if not pregnant, not planning to become pregnant during the course of the study, and committed to use of contraceptive methods with a failure rate of less than 1 percent per year

You may not qualify if:

• Celiac disease
• Diagnosis of ulcerative or indeterminate colitis
• Enterocutaneous, abdominal or pelvic fistulae with abscesses, or fistulae likely to require surgery during the course of the study period
• Bowel surgery, other than appendectomy, within 12 weeks prior to Week -4 Visit and/or has planned surgery or deemed likely to need surgery for Crohn's disease during the study period
• Extensive colonic resection, subtotal or total colectomy
• Presence of ileostomies, colostomies or rectal pouches
• Fixed symptomatic stenoses of small bowel or colon
• History of more than 3 small bowel resections or diagnosis of short bowel syndrome
• Use of prohibited medications inside the specified washout period (prior to Week -4 Visit), and throughout the study. Prohibited medications include the following:
• TNF antagonists and vedolizumab may continue throughout the study, but treatments should have been given at a stable dose for at least 6 months prior to the screening date and should be maintained at this level throughout the study
• Use of any natalizumab within 8 weeks
• Use of glucocorticoids at doses greater than 10 mg prednisone orally QD, or an equivalent dose of other oral or parenteral glucocorticoids within 4 weeks
• Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks
• Use of intravenous antibiotics for Crohn's disease within 4 weeks
• Use of tube or enteral feeding, or elemental diet within 2 weeks

Sponsors & Collaborators

• SetPoint Medical Corporation: lead

Study Sites (4)

Clinical Hospital Dubrava

Zagreb, Croatia

Location

Humanitas Research Hospital

Milan, Italy

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Karolinska University Hospital, Solna

Stockholm, Sweden

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Geert D'Haens, M.D., Ph.D.

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 8, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); SE (1); CR (1); IT (1)