Trip-Tox, Effectiveness of Triptans Before and After Onabotulinumtoxin A Treatment in Chronic Migraine

NCT04871152 | Unknown FDA Drug

• 1 other identifier: IIBSP-TOX-2020-67
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Observational, longitudinal, prospective, prospective, comparative study of the effectiveness of triptans before and after onabotulintoxin A initiation in a single group of chronic migraine patients.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (4)

• Change efficacy (Pain free at two hours )

  Percentage of patients who are completely free of pain after two hours of ingestion of their usual triptan.

  From baseline to 4 months

• Change efficacy (Pain free at two hours )

  Percentage of patients who are completely free of pain after two hours of ingestion of their usual triptan.

  From baseline to 7 months

• Satisfaction (Likert scale 1-5)

  Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA

  From baseline to 4 months

• Satisfaction (Likert scale 1-5)

  Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA

  From baseline to 7 months

Secondary Outcomes (3)

• Pain free at one hour

  4 and 7 months

• Sustained pain-free

  4 and 7 months

• Headache relapse

  4 and 7 months

Study Arms (1)

Patients with chronic migraine

In the same group of patients, the response to triptans will be analyzed at 3 different times with respect to the start of treatment with onabotulinumtoxinA: before treatment, after 4 months and after 7 months of treatment.

Drug: OnabotulinumtoxinA

Interventions

OnabotulinumtoxinA DRUG

To compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA.

Also known as: Triptans

Patients with chronic migraine

Eligibility Criteria

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

Study Population

Patients who meet criteria for chronic migraine and have failed 2 or more oral preventive treatments (including topiramate) or have a contraindication to taking topiramate.

You may qualify if:

• ICHD-3 criteria for chronic migraine (code 1.3). See Table 3.
• Older than 18 years and younger than 65 years.
• Migraine started in their lifetime before the age of 50 years.
• Migraine of more than one year of evolution since diagnosis.
• Normal cranial CT/MRI study.
• Indication for treatment with Botox
• Taking triptans as a rescue treatment for migraine attacks

You may not qualify if:

• Pregnant women
• Migraine of less than one year of evolution since diagnosis.
• Pathologies that contraindicate the use of OnabotulinumtoxinA (myasthenia gravis, myopathies).

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Headache and Neuralgia Unit. Neurology Department. Hospital Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A; Tryptamines

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; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robert Belvís, PhD

  Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Belvís, PhD

CONTACT

+34 93 291 90 00; rbelvis@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 4, 2021
• Study Start: March 25, 2021
• Primary Completion: September 25, 2022
• Study Completion: September 25, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

ES (1)