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REsponse to Combined SONS and ONS in Chronic Cluster headachE (RESPONSE)

Primary Purpose

Chronic Cluster Headache

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
PRIMUS
Sponsored by
Salvia BioElectronics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Chronic Cluster Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Able and willing to provide informed consent Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) Stable on preventive treatment for at least two weeks prior to enrolment. Agree to refrain from starting new prophylactic cluster headache medication or other preventive treatments, from 4 weeks before entering the baseline period throughout the duration of the study MRI available (not older than 4 years prior to study enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache Able and willing to complete a headache Diary Main Exclusion Criteria: Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms Concomitant neuromodulation, except tVNS Previous failure to any implantable neuromodulation device for neurovascular headache Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …) Metal implants in the skull (e.g. skull plates, seeds) nearby the implant Have a pacemaker or implantable cardioverter defibrillator (ICD) Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months Use of botulinum toxin injections in the past 12 weeks Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment Women of childbearing age who are pregnant, nursing or not using contraception

Sites / Locations

  • Resolve PainRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRIMUS

Arm Description

PRIMUS PNS System

Outcomes

Primary Outcome Measures

Safety Evaluation
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at 30 days.
Safety Evaluation
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at the end of the study.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2023
Last Updated
August 23, 2023
Sponsor
Salvia BioElectronics
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1. Study Identification

Unique Protocol Identification Number
NCT05868044
Brief Title
REsponse to Combined SONS and ONS in Chronic Cluster headachE
Acronym
RESPONSE
Official Title
REsponse to Combined SuPra-orbital and Occipital Nerve Stimulation in Chronic Cluster headachE With the PRIMUS System, a First in Human Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salvia BioElectronics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the safe use of a novel cranio-facial Peripheral Nerve Stimulator PNS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PNS System for the treatment of chronic cluster headache.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cluster Headache

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRIMUS
Arm Type
Experimental
Arm Description
PRIMUS PNS System
Intervention Type
Device
Intervention Name(s)
PRIMUS
Intervention Description
Peripheral Nerve Stimulator System
Primary Outcome Measure Information:
Title
Safety Evaluation
Description
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at 30 days.
Time Frame
4 weeks
Title
Safety Evaluation
Description
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at the end of the study.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Able and willing to provide informed consent Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) Stable on preventive treatment for at least two weeks prior to enrolment. Agree to refrain from starting new prophylactic cluster headache medication or other preventive treatments, from 4 weeks before entering the baseline period throughout the duration of the study MRI available (not older than 4 years prior to study enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache Able and willing to complete a headache Diary Main Exclusion Criteria: Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms Concomitant neuromodulation, except tVNS Previous failure to any implantable neuromodulation device for neurovascular headache Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …) Metal implants in the skull (e.g. skull plates, seeds) nearby the implant Have a pacemaker or implantable cardioverter defibrillator (ICD) Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months Use of botulinum toxin injections in the past 12 weeks Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment Women of childbearing age who are pregnant, nursing or not using contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wim Pollet, MD
Phone
+32 498 57 98 98
Email
wim.pollet@salvianeuro.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Frank, MD
Organizational Affiliation
Resolve Pain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Resolve Pain
City
Buderim
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Frank, MD
Email
clinicaltrial@resolvepain.com.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

REsponse to Combined SONS and ONS in Chronic Cluster headachE

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