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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06450444




Registration number
NCT06450444
Ethics application status
Date submitted
4/06/2024
Date registered
10/06/2024
Date last updated
15/11/2024

Titles & IDs
Public title
The RECLAIM Study.
Scientific title
Randomized, Double-blind, Sham-controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. the RECLAIM Study.
Secondary ID [1] 0 0
SCI-03-RM
Universal Trial Number (UTN)
Trial acronym
RECLAIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Migraine 0 0
High Frequency Episodic Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - PRIMUS

Experimental: Treatment Group - Active Stimulation

Other: Control Group - Sham stimulation


Treatment: Devices: PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Evaluation
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Effectiveness Evaluation
Timepoint [2] 0 0
12 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Resolve Pain - Buderim
Recruitment hospital [3] 0 0
Monash House Private Hospital - Clayton
Recruitment postcode(s) [1] 0 0
NSW, 2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
4556 - Buderim
Recruitment postcode(s) [3] 0 0
VIC, 3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Limburg
Country [2] 0 0
Belgium
State/province [2] 0 0
West Vlaanderen
Country [3] 0 0
Belgium
State/province [3] 0 0
Roeselare
Country [4] 0 0
Belgium
State/province [4] 0 0
Wilrijk

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Salvia BioElectronics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06450444
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06450444