Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Chronic Cluster Headache Clinical Trial

Official title:

Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255813
• Other study ID #: Pathway CH-1 (CIP-001)
• Status: Completed
• Phase: N/A
• First received: December 3, 2010
• Last updated: December 28, 2015
• Start date: December 2010
• Est. completion date: March 2013

Study information

• Verified date: December 2015
• Source: Autonomic Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Cluster Headache
• Cluster Headache
• Headache

Intervention

Device:
• Stimulation (Sub-perception)
Stimulation applied below the perception threshold
• Stimulation (Full)
Stimulation applied above the perception threshold

Other:
• Control
No stimulation applied

Locations

Country	Name	City	State
Belgium	Citadelle Hospital	Liege
Denmark	Danish Headache Center, Dept. of Neurology, Glostrup Hospital	Glostrup
Germany	Headache Center, Dept. of Neurology, University Duisburg-Essen	Essen
Germany	Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)	Hamburg
Spain	Department of Neurology, University Clinic Hospital, University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Autonomic Technologies, Inc.

Countries where clinical trial is conducted

Belgium,  Denmark,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of device related Serious Adverse Events (SAEs)		Implant through the Experimental Period	Yes
Primary	Acute Pain Relief response (as defined by patient)		15 minutes	No
Secondary	Pain Freedom		15 minutes	No
Secondary	Rescue medication use	Use of medications to treat headache pain within 90 minutes after initiating therapy.	90 minutes	No
Secondary	Pain Relief after initiating therapy		30 minutes	No
Secondary	Pain Relief after initiating therapy		60 minutes	No
Secondary	Pain Relief after initiating therapy		90 minutes	No