Botox Vs Spinal Cord Stimulation in the Treatment of Refractory Migraine Clinical Trial

NCT05382832 | Unknown DMC

• 1 other identifier: NSM 1-128/2021
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The clinical trial is focused on the treatment of selected patients with a migraine after implantation of spinal cord stimulator (SCS) based on previous neurological examination. Patients will be randomized and divided into two groups. According to randomization patients will receive saline or botox into the epidural space. The efficacy of treatment will be compared and estimated in both groups during different SCS settings. Data will be collected in pre-set time frames.

Conditions

Migraine

Outcome Measures

Primary Outcomes (6)

• Health Questionnaire (EQ-5D-5L)

  1 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems

  14 days after the SCS implant

• Health Questionnaire (EQ-5D-5L)

  Week 13 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems

  91 days after the SCS implant

• Health Questionnaire (EQ-5D-5L)

  Week 25 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems

  175 days after the SCS implant

• Health Questionnaire (EQ-5D-5L)

  Week 28 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems

  196 days after the SCS implant

• Health Questionnaire (EQ-5D-5L)

  Week 40 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems

  280 days after the SCS implant

• Health Questionnaire (EQ-5D-5L)

  Week 52

  364 dayss after the SCS implant

Secondary Outcomes (4)

• Visual numeric scale

  daily up to 10 days

• Type of migraine

  up to 1 week

• Aura presence

  up to 1 week

• Duration of the migraine episode

  up to 1 week

Study Arms (8)

A1 Group SCS

EXPERIMENTAL

Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting two weeks after the SCS implant

Combination Product: SCS

A1 Group Botox

EXPERIMENTAL

Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting two weeks after the SCS implant

Combination Product: SCS

B1 Group SCS

PLACEBO COMPARATOR

Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting two weeks after the SCS implant

Combination Product: SCS

B1 Group Saline

PLACEBO COMPARATOR

Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting two weeks after the SCS implant

Combination Product: SCS

A2 Group SCS

EXPERIMENTAL

Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting at the 28th week of clinical trial investigation

Combination Product: SCS

A2 Group Botox -after washout period

EXPERIMENTAL

Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting at the 28th week of clinical trial investigation

Combination Product: SCS

B2 Group SCS

PLACEBO COMPARATOR

Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting at the 28th week of clinical trial investigation

Combination Product: SCS

B2 Group Saline -after washout period

PLACEBO COMPARATOR

Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting at the 28th week of clinical trial investigation

Combination Product: SCS

Interventions

SCS COMBINATION_PRODUCT

SCS-experimental treatment

Also known as: Botox

A1 Group Botox; A1 Group SCS; A2 Group Botox -after washout period; A2 Group SCS; B1 Group SCS; B1 Group Saline; B2 Group SCS; B2 Group Saline -after washout period

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• migraine presence

You may not qualify if:

• disagreement with participation in the study

Sponsors & Collaborators

• Europainclinics z.ú.: lead
• National Hospital for Neurology and Neurosurgery, London: collaborator

MeSH Terms

Conditions

Migraine Disorders

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Róbert Rapcan, MD, PhD, MBA, FIPP

  EuroPainClincs

  STUDY CHAIR

• Ladislav Kočan, MD, PhD

  EuroPainClincs

  STUDY CHAIR

Central Study Contacts

Ashish Shetty, MD, FRCA, FFPMRCA

CONTACT

+447723309217; drashshetty@gmail.com

Nicolas Varela, MD, DESA

CONTACT

+447723309217

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In order to have a double-blinded RCT, the investigators will not be aware of the trial branch of the participants. Injections will be performed either with Botulinum Toxin or with Normal Saline and Spinal Cord Stimulators will be configured in order to use high-frequency stimulation or a sham treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-Blinded, Randomized, Controlled Trial

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 19, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2025
• Last Updated: May 19, 2022

Record last verified: 2022-05