Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

NCT01255813 | Completed DMC

• 1 other identifier: Pathway CH-1 (CIP-001)
• Study Type: interventional
• Target: 43
• Locations: 4 countries
• Sites: 5

Brief Summary

The purpose of the proposed clinical study is to evaluate the use of an implanted Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of the pain associated with cluster headaches.

Conditions

Chronic Cluster Headache

Keywords

Chronic Cluster Headache

Outcome Measures

Primary Outcomes (2)

• Number of device related Serious Adverse Events (SAEs)

  Implant through the Experimental Period

• Acute Pain Relief response (as defined by patient)

  15 minutes

Secondary Outcomes (5)

• Pain Freedom

  15 minutes

• Rescue medication use

  90 minutes

• Pain Relief after initiating therapy

  30 minutes

• Pain Relief after initiating therapy

  60 minutes

• Pain Relief after initiating therapy

  90 minutes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Other: Control

Sub-perception

EXPERIMENTAL

Device: Stimulation (Sub-perception)

Full Stimulation

EXPERIMENTAL

Device: Stimulation (Full)

Interventions

Stimulation (Sub-perception) DEVICE

Stimulation applied below the perception threshold

Sub-perception

Stimulation (Full) DEVICE

Stimulation applied above the perception threshold

Full Stimulation

Control OTHER

No stimulation applied

Placebo

Eligibility Criteria

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

You may qualify if:

• Age from 18 to 65 years old (inclusive).
• Subject has been diagnosed with chronic cluster headache according to the 2004 International Headache Society (IHS) criteria 3.1.2.
• Subject reports a minimum of 4 cluster headaches per week.
• Subject reports dissatisfaction with current cluster headache treatment (Criterion includes both preventive or abortive therapy per the Investigator's standard of care. Reasons for dissatisfaction with existing headache therapies may include failure of therapies, contraindication, side effects of therapies, or patient refusal of available therapies)
• Subject is able to distinguish cluster headaches from other headaches (i.e., tension-type headaches).
• Subject has the ability to read and comprehend, and to reliably record information as required by the Protocol.
• Subject is able to provide written informed consent prior to participation in the study.

You may not qualify if:

• Subject has had a change in type or dosage of prophylactic headache medications \< one (1) month prior to study enrollment
• Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned implant site within the last four (4) months.
• Subject has active oral or dental abscess.
• Subject has been treated with radiation to the facial region within the last six (6) months.
• Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past six (6) months.
• Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
• Subject is a woman of childbearing age who is pregnant, nursing, or not using contraception.
• Subject is currently participating or has participated in the last month in another clinical study in which the subject has, is, or will be exposed to an investigational or non-investigational drug or device.
• Subject is felt to be at risk of non-compliance (e.g., for completing the diary or maintaining a stable headache medicine regimen) in the Investigator's opinion.
• Subject has had previous lesional radio-frequency ablation of the ipsilateral sphenopalatine ganglion (SPG).
• Subject has had blocks of the ipsilateral SPG in the last three (3) months.
• Subject has undergone botulinum toxin injections of the head and/or neck in the last three (3) months.
• Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier.
• Subject has a history of bleeding disorders or coagulopathy or is unable to discontinue anticoagulation, antiplatelet, or GP IIb IIIa inhibitor medication in preparation for the implantation procedure.
• Subject is not suitable for the study for any reason in the judgment of the Investigator.

Sponsors & Collaborators

• Autonomic Technologies, Inc.: lead

Study Sites (5)

Citadelle Hospital

Liège, Belgium

Location

Danish Headache Center, Dept. of Neurology, Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Headache Center, Dept. of Neurology, University Duisburg-Essen

Essen, 45147, Germany

Location

Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

Location

Department of Neurology, University Clinic Hospital, University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jean Schoenen, M.D.

  Professor of Functional Neuroanatomy, Leige University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 7, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

DK (1); BE (1); ES (1); DE (2)