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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
9/08/2024

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,VIC
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Monash House Private Hospital - Clayton
Recruitment postcode(s) [1] 0 0
NSW, 2292 - Broadmeadow
Recruitment postcode(s) [2] 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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06450444