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Chronic Migraine, HeadacheNCT06133491

Open Label, 6-month Study for High Frequency and Chronic Migraine,

An observational study of Chronic Migraine, Headache, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This is a prospective, multi-center, unblinded study in patients with migraine (≥ 8 MMDs/month) requiring preventive treatment. Enrolled patients will receive DAX administered subcutaneously using an established, published, legacy injection paradigm (referred to herein as the "standard paradigm"). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Migraine, Headache
What is being tested?
Daxibotulinumtonix A
Type of treatment
Injection or infusion
How many people
20 participants
Where
2 sitesUnited States
Study dates
18 Oct 2023to Dec 2024
How long will I take part?
6 Months
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
  • Adult, Older adult

Study population: Men and Women 18-75 years old with migraines (≥ 8 MMDs/month) requiring preventive treatment.

Who may be able to join

  • Written informed consent must be obtained from the subject in accordance with requirements of the study site's 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, 3rd edition with the following:
  • Age of onset prior to 50 years of age
  • Migraine attacks lasting on average 4-72 hours untreated.
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  • 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 randomization and for two months after the end of the study. 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 = 3 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 BoNT therapy (no minimum or cap) or have received BoNT therapy provided there is a 3-month washout period.
  • A minimum of 30% of eligible subjects will be Chronic Migraine, per ICHD-3 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 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 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,
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  • 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,
  • Known or suspected serious neuromuscular, respiratory or cardiovascular disorder (such as amyotrophic lateral sclerosis, myasthenia gravis, severe chronic obstructive pulmonary disorder, 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 Prevention in High-Frequency and Chronic Migraine: the Standard Paradigm

This is a prospective, multi-center, unblinded study in patients with migraine (≥ 8 MMDs/month) requiring preventive treatment. Enrolled patients will receive DAX administered subcutaneously using an established, published, legacy injection paradigm (referred to herein as the "standard paradigm"). The safety and efficacy outcome measures will be assessed at selected dosing segments during the 24-week treatment phase.

Read the detailed description

Patients enrolled who meet eligibility will receive a total of 310 units of DAXI Injections in divided doses over 31 landmarks (sites), including the face, head, neck and shoulders, as identified per the standard paradigm, at visit 2. Follow-up visits via combination of phone and in office will occur at V3, week 8, through V9, week 24.

Being tested
Daxibotulinumtonix A
Medical subject headings
Headache

What participants receive

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

  • Daxibotulinumtonix ABiological

    SQ injections of 10u per site will be given over standard landmarks (18 sites) to patients who consent and are found eligible.

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 over weeks 9-12 as determined by patients reported outcomes on the daily headache diary.

    Measured: Over weeks 9-12 (4 week period)

Secondary outcomes (6)

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

    Time to wear-off that would qualify the patient for retreatment.

    Measured: 4 weeks - Over weeks 5-8

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

    Time to wear-off that would qualify the patient for retreatment.

    Measured: 4 weeks - 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.

    Time to wear-off that would qualify the patient for retreatment.

    Measured: 4 weeks - 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.

    Time to wear-off that would qualify the patient for retreatment.

    Measured: 4 weeks - over weeks 9-12

  5. Change from baseline in the MIDAS score at week 12.

    Time to wear-off that would qualify the patient for retreatment.

    Measured: Week 12

  6. Change from baseline in the PGIC at multiple time points during 6 month study

    Time to wear-off that would qualify the patient for retreatment.

    Measured: over duration of study (6 months)

Timeline

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

  1. First posted15 Nov 2023
  2. Study start18 Oct 2023
  3. Primary completionSep 2024 (estimated)
  4. Study completionDec 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
20 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06133491
Sponsor's protocol ID
REV-002 Standard Paradigm
Status last verified
Aug 2024
First submitted
3 Nov 2023
Last updated
27 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Migraine, Headache, 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 18 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 27 Aug 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 over weeks 9-12 as determined by patients reported outcomes on the daily headache diary. (time frame: Over weeks 9-12 (4 week period)). 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 NCT06133491.

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 27 Aug 2024.

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