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The RECLAIM Study.

S

Salvia BioElectronics

Status

Enrolling

Conditions

High Frequency Episodic Migraine
Chronic Migraine

Treatments

Device: PRIMUS

Study type

Interventional

Funder types

Industry

Identifiers

NCT06450444
SCI-03-RM

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.

Enrollment

62 estimated patients

Sex

All

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening
  • Failure of 3 or more preventive pharmacological therapies
  • Stable on preventive migraine treatments
  • Psychologically stable

Exclusion criteria

  • Concomitant invasive or non-invasive neuromodulation
  • Previous exposure to an implantable neuromodulation device for headache
  • Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant)
  • Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.
  • Use of steroid infiltrations or IV administration in the past 3 months.
  • Not pregnant, nursing or not using contraception

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

62 participants in 2 patient groups

Treatment Group
Experimental group
Description:
Active Stimulation
Treatment:
Device: PRIMUS
Control Group
Other group
Description:
Sham stimulation
Treatment:
Device: PRIMUS

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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