AzTrials
AzTrials

Migraine DisordersNCT06154070

An Open Label, Study of DaxibotulinumtoxinA for Migraine Prevention

An observational study of Migraine Disorders, run by Ki Health Partners. LLC at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a prospective, multi-center, unblinded study in patients with migraine (≥ 8 MMDs(monthly migraine days)/month) requiring preventive treatment. Enrolled patients will receive DAXXIFY (DAX/Doxibutlinumtoxin A)administered subcutaneously per the EEG paradigm (injection pattern). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine Disorders
What is being tested?
DaxibotulinumtoxinA
Type of treatment
Injection or infusion
How many people
10 participants
Where
2 sitesUnited States
Study dates
24 Oct 2023to Oct 2024
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Males and Females diagnosed with Migraines between the ages of 18-75years of age who meet the eligibility criteria

Who may be able to join

  • Written informed consent must be obtained from the subject in accordance with requirements of the study site's Institutional Review Board (IRB) or ethics committee, prior to initiation of any protocol-specified procedures.
  • Subject must be able to read.
  • Male or female subjects, 18 to 75 years of age inclusive.
  • Subject has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to ICHD (International Classification of Headache Disorder), 3rd edition with the following:
  • Age of onset prior to 50 years of age
  • Migraine attacks lasting on average 4-72 hours untreated.
Show all 16Show fewer
  • By subject report at least 8 migraine days of moderate or severe intensity per month over the previous 3 months (prior to screening)
  • Ability to distinguish migraine from non-migraine headache.
  • No more than 26 headache days of any type per month by subject report.
  • Patients with at least 8 qualified migraine days per month over the three months prior to Screening will be eligible for entry into this study (assessed by historical recall). A migraine attack must last at least 30 minutes. Any use of an acute migraine-specific medication will count as a migraine attack (day). The interval between two qualified migraine days should be at least 24 hours to be counted as distinct migraine attacks. A migraine attack that remits following treatment (or sleep) and recurs within 24 hours will be counted as one migraine attack.
  • Females should be either of non-childbearing potential by reason of surgery, radiation, menopause (one year post onset), or of childbearing potential and practicing a medically acceptable method of contraception (eg, abstinence, a barrier method plus spermicide, or IUD) for at least one month before study participation and for two months after the end of the study and have a negative urine B-hCG (Beta-human chorionic gonadotropin) at Screening. Pregnant and/or lactating females are excluded. Those women using hormonal contraceptives must also be using an additional approved method of contraception (eg, a barrier method plus spermicide, or IUD) starting with the Baseline Phase and continuing throughout the entire study period.
  • A sub-set of subjects (capped at 30% of total enrolled) on not more than 1 preventive migraine medication may remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the observation period and is not expected to change.
  • Exceptions include onobotulinumtoxinA treatment (wash out = 4 months).
  • Patients who are able and willing to attend study visits, maintain a headache diary and otherwise comply with study related activities.
  • Patients may be naive to botulinum neuro toxin (BoNT) therapy (no minimum or cap), or have received BoNT therapy provided there is a 4-month washout period.
  • A minimum of 30% of eligible subjects will be Chronic Migraine, per ICHD-3 (The International Classification of Headache Disorder) criteria.

Who cannot join

  • Migraine patients with ≥26 headache days of any kind per month by historical report over the 3 months prior to study.
  • Patients with cluster headaches and other trigeminal autonomic cephalalgias, and other primary headaches (except tension-type headache) and secondary headaches (defined according to the Headache Classification Committee of the Internationals Headache Society (IHS), 3rd Edition, 2018),
  • Patients with a history of being non-responsive to adequate trials of more than two classes of migraine preventive treatments (e.g., beta blockers, calcium channel blockers, tricyclics, divalproex, topiramate, small or large molecule calcitonin gene-related peptide (CGRP) antagonists or onobotulinumtoxinA).
  • Patients who use the following medications as described:
  • Use of triptans, ditans or ergot-containing medications for 10 days or greater per month on average,
  • Use of NSAIDs, acetaminophen or combination analgesics (such as acetaminophen-caffeine products) 15 days or greater per month on average,
Show all 19Show fewer
  • Use of opioids and/or butalbital containing medications for 4 days or greater per month on average,
  • Use of any two or more of the above medications (excluding opioids/butalbital) for 15 days or greater per month on average,
  • Patients with clinically significant neurological illness, other than migraine, that, in the opinion of the Investigators, may have the potential of altering pain perception or reporting.
  • Preexisting or current difficulties swallowing or breathing.
  • Known or suspected serious neuromuscular, or cardiovascular disorder (such as amyotrophic lateral sclerosis, myasthenia gravis, coronary artery disease). that in the opinion of the investigator would place the participant at increased risk of an adverse event.
  • Patients with a history of or currently having major psychiatric disorders including schizophrenia, active psychosis or bipolar disorder. Major depressive disorder and generalized anxiety disorder which, in the investigator's opinion are well-controlled, will be allowed.
  • Patients with clinically significant active hepatic disease, cardiovascular, metabolic, respiratory, renal, endocrinological (including poorly controlled diabetes mellitus), gastrointestinal diseases, and bacterial or viral infections within 30 days prior to Screening or during the Baseline Phase, that in the opinion of the investigator may interfere with subject's participation in the study or may present a risk of the subject not completing the study.
  • Patients with hematologic or solid malignancy diagnosis within 5 years prior to screening with the exception of basal cell carcinoma and squamous cell carcinoma if they have been cancer free prior to screening.
  • Body mass index of <18 or >35.
  • Patients who within the past 3 years have a history of or have been treated for alcohol or drug abuse.
  • Women who are unwilling or unable to use acceptable contraception during the study.
  • Women who are pregnant or breastfeeding.
  • Patients who have participated in a drug intervention study for any indication within 60 days (or 5 half-lives of the investigational drug, whichever is longer) or non-drug intervention study (such as electrical stimulation) within 30 days.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The Los Angeles Headache Center

    Los Angeles, California, 90067

  • New England Institute For Clinical Research

    Stamford, Connecticut, 06905

Other trials in United States

About this study

Official title: A Multi-Center Unblinded Proof-of-Concept Study of DaxibotulinumtoxinA for Migraine: the 'EEG Paradigm'

This is a prospective, multi-center, unblinded study in patients with migraine (≥ 8 MMDs(monthly migraine days)/month) requiring preventive treatment.

Enrolled patients will receive DAXXIFY (DAX/Doxibutlinumtoxin A)administered subcutaneously per the EEG paradigm (injection pattern).

The safety and efficacy outcome measures will be assessed at selected dosing segments during the 24-week treatment phase as well as the Post Treatment (4 weeks).

There are 2 sites in the U.S. participating, where a total of 20 patients will be enrolled.

Read the detailed description

This is an open-label, 24-week trial of DAX for the preventive treatment of frequent migraine attacks ( ≥8 MMDs per month, currently termed high-frequency episodic migraine (HFEM), or if there are 15 or more of any headache type, CM).

The purpose of this study is to assess the safety and effectiveness of the study drug, DaxibotulinumtoxinA (DAXXIFY) over a 24-week period. DaxibotulinumtoxinA (Manufactured by Revance Therapeutics, Inc.).

The primary objective of this proof-of-concept study is to evaluate DAX effectiveness administered subcutaneously according to a novel, proprietary injection pattern ("EEG paradigm") for the preventive treatment of High Frequency Migraine/Chronic Migraine (HFEM/CM) assessed by reduction of monthly migraine days.

Evaluation of the duration of efficacy as determined by prespecified rules for retreatment (50% or increase in MMDs from nadir (look-back to weeks 4-12) beginning at week 16, along with a 1-point or more worsening in the PGIC.

  • Evaluation of the safety of DAX in migraine patients
  • Evaluation of time to "wear-off" (need for retreatment)
  • Reduction of acute migraine medication use compared to baseline
  • Patient-reported outcomes (PROs):
  • MIDAS
  • PGIC (Patient Global Impression of Change)
Being tested
DaxibotulinumtoxinA
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaxibotulinumtoxinADrug

    Patients enrolled who meet eligibility will receive a total of 344 units of DAXI Injections in divided doses over 19 landmarks, including the face, head and shoulders, as identified per the EEG paradigm, at visit 2.

    Follow-up visits via combination of phone and in office will occur at V3, week 8 thru V9, week 24.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in monthly migraine days

    to determine the change in migraine days from baseline visit thru 12 weeks.

    Measured: Over weeks 9-12

Secondary outcomes (6)

  1. Change from baseline in monthly migraine days over weeks 5-8

    Measured: Over weeks 5-8

  2. The percentage of patients with a ≥50% reduction from baseline in monthly migraine days over weeks 9-12.

    Measured: Over weeks 9-12

  3. The percentage of patients with a ≥75% and 100% reduction from baseline in monthly migraine days over weeks 9-12.

    Measured: Over weeks 9-12

  4. Change from baseline in the mean monthly migraine headache days requiring acute medication use to treat a migraine or headache across weeks 9-12.

    Measured: Across weeks 9-12

  5. Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function domain score at week 12 compared to baseline.

    Measured: Week 12 compared to Baseline.

  6. Change from baseline in the MIDAS score at week 12, 16 and 20.

    Measured: Baseline to week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2023
  2. Study start24 Oct 2023
  3. Primary completionSep 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06154070
Sponsor's protocol ID
REV-001
Status last verified
Mar 2024
First submitted
3 Nov 2023
Last updated
10 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine Disorders, run by Ki Health Partners. LLC at 2 sites in United States.

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 16 inclusion and 19 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in monthly migraine days (time frame: Over weeks 9-12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06154070.

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 10 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in