Chronic MigraineNCT04871152
Trip-Tox, Effectiveness of Triptans Before and After Onabotulinumtoxin A Treatment in Chronic Migraine
An observational study of Chronic Migraine, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- OnabotulinumtoxinA
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 25 Mar 2021to 25 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant women
- Migraine of less than one year of evolution since diagnosis.
- Pathologies that contraindicate the use of OnabotulinumtoxinA (myasthenia gravis, myopathies).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Headache and Neuralgia Unit. Neurology Department. Hospital Santa Creu i Sant Pau
Barcelona
Robert Belvís, PhD, +34 93 291 90 00, rbelvis@santpau.cat
About this study
Official title: Trip-tox Study. Analysis of the Efficacy and Satisfaction of Symptomatic Treatment With Triptans in Patients With Chronic Migraine Undergoing onabotulinumtoxinA Treatment
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.
Read the detailed description
Hypothesis In patients with chronic migraine the efficacy of triptans, previously taken by the patient for the migraine attack, is better and more satisfactory after starting treatment with onabotulinumtoxinA.
Objectives To analyze the efficacy and satisfaction of the triptan usually taken by the patient with chronic migraine before starting preventive treatment with onabotulinumtoxinA, at 4 months, after two sessions of Botox, and at 7 months of treatment, after three sessions of Botox.
Sample size n=100 patients with chronic migraine in whom treatment with onabotulinumtoxinA is indicated. The indication for Botox treatment will be performed as usual and the patient will take his usual triptan if he has a migraine attack, so there is no therapeutic modification in this study that could involve any bioethical issue.
All patients signed the informed consent and the study was approved by the Comitè d'Ètica de la Investigació amb Medicaments (CEIm) de l'Hospital de la Santa Creu i Sant Pau.
- Conditions
- Chronic Migraine
- Being tested
- OnabotulinumtoxinA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Also called Triptans
To compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: OnabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to 7 months
Satisfaction (Likert scale 1-5)
Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA
Measured: From baseline to 4 months
Satisfaction (Likert scale 1-5)
Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA
Measured: From baseline to 7 months
Secondary outcomes (3)
Pain free at one hour
Percentage of patients who are completely free of pain after one hour of ingestion of their usual triptan.
Measured: 4 and 7 months
Sustained pain-free
Percentage of patients who achieve pain-free at two hours and do not require rescue medication within 24-48 hours.
Measured: 4 and 7 months
Headache relapse
Percentage of patients experiencing recurrence of pain within 48 h on triptans with long half-life or 24 h on triptans with short half-life.
Measured: 4 and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start25 Mar 2021
- Primary completion25 Sep 2022 (estimated)
- Study completion25 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Belvís, PhD, Principal investigator, Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871152
- Sponsor's protocol ID
- IIBSP-TOX-2020-67
- Status last verified
- Oct 2021
- First submitted
- 23 Apr 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trip-tox Study. Analysis of the Efficacy and Satisfaction of Symptomatic Treatment With Triptans in Patients With Chronic Migraine Undergoing onabotulinumtoxinA Treatment
- ClinicalTrials.gov ID
- NCT04871152
- Acronym / sponsor ID
- IIBSP-TOX-2020-67
- Conditions
- Chronic Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 25 Sep 2022 (estimated)
- Study completion
- 25 Sep 2022 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis In patients with chronic migraine the efficacy of triptans, previously taken by the patient for the migraine attack, is better and more satisfactory after starting treatment with onabotulinumtoxinA.
Objectives To analyze the efficacy and satisfaction of the triptan usually taken by the patient with chronic migraine before starting preventive treatment with onabotulinumtoxinA, at 4 months, after two sessions of Botox, and at 7 months of treatment, after three sessions of Botox.
Sample size n=100 patients with chronic migraine in whom treatment with onabotulinumtoxinA is indicated. The indication for Botox treatment will be performed as usual and the patient will take his usual triptan if he has a migraine attack, so there is no therapeutic modification in this study that could involve any bioethical issue.
All patients signed the informed consent and the study was approved by the Comitè d'Ètica de la Investigació amb Medicaments (CEIm) de l'Hospital de la Santa Creu i Sant Pau.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic migraine | – | Drug: OnabotulinumtoxinAIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant women
- Migraine of less than one year of evolution since diagnosis.
- Pathologies that contraindicate the use of OnabotulinumtoxinA (myasthenia gravis, myopathies).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAAlso: TriptansTo compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA. | Drug | Patients with chronic migraine |
Primary outcome
Change efficacy (Pain free at two hours )
Time frame: From baseline to 4 months
Percentage of patients who are completely free of pain after two hours of ingestion of their usual triptan.
Change efficacy (Pain free at two hours )
Time frame: From baseline to 7 months
Percentage of patients who are completely free of pain after two hours of ingestion of their usual triptan.
Satisfaction (Likert scale 1-5)
Time frame: From baseline to 4 months
Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA
Satisfaction (Likert scale 1-5)
Time frame: From baseline to 7 months
Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA
3 secondary outcomes
Pain free at one hour
Time frame: 4 and 7 months
Sustained pain-free
Time frame: 4 and 7 months
Headache relapse
Time frame: 4 and 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Belvís, PhD principal investigator
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Migraine, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Belvís, PhD (+34 93 291 90 00, rbelvis@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change efficacy (Pain free at two hours ) (time frame: From baseline to 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.