Combination of Botox + CGRPmAb for Migraine

Chicago Headache Center & Research Institute, Chicago, IL
MigraineCombination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL) - Drug
Eligibility
18 - 75
All Sexes

Study Summary

This trial seeks to prove the combo of OnabotulinumtoxinA and CGRPmAbs is effective for chronic migraine, which may help patients get better coverage.

Eligible Conditions
  • Chronic Migraine

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 6 months

6 months
Decrease in number of monthly migraine days with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.
To assess improvements in HIT-6 (Headache Impact Test) score of >5 point reduction with the addition of CGRPmAb Fremanezumab in chronic migraine patients currently on monotherapy OnabotulinumtoxinA.

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Combination of Botox + CGRPmAb
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Combination of Botox + CGRPmAb · No Placebo Group · Phase 4

Combination of Botox + CGRPmAb
Drug
Experimental Group · 1 Intervention: Combination of Botox + CGRPmAb (Fremanezumab 225mg/1.5mL) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Chicago Headache Center & Research InstituteLead Sponsor
1 Previous Clinical Trials
164 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who are 18 to 75 years old, who suffer from chronic migraine.
You have been experiencing migraine headaches for at least a year.
References

Frequently Asked Questions

Is it possible for me to join this clinical trial?

"A prerequisite for enrolment in this medical trial is chronic migraine and a patient's age must fall between 18 - 75. This research program has an allocated recruitment quota of 50 participants." - Anonymous Online Contributor

Unverified Answer

Is enrollment into this experiment available at the present time?

"As indicated by the clinicaltrials.gov portal, this medical trial is recruiting participants at present. The post was issued on January 26th 2023 and recently modified on February 2nd of the same year." - Anonymous Online Contributor

Unverified Answer

Does this study accept participants aged 55 and older?

"To be eligible for this trial, potential participants must range from 18 to 75 years old. Seperate trials exist for those under 18 (42 studies) and over 65 (177 studies)." - Anonymous Online Contributor

Unverified Answer

What risks and benefits come with the Combination of Botox + CGRPmAb treatment?

"This combination of Botox and CGRPmAb has been given a score of 3, as it is currently in Phase 4 trials - meaning approval has already been granted." - Anonymous Online Contributor

Unverified Answer

How many individuals are being enrolled in this inquiry?

"Affirmative. According to clinicaltrials.gov, this medical trial is presently in search of participants and was introduced on January 26th 2023 with a recent update occurring February 2nd 2023. It needs 50 patients from one location to complete the study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.