Open Label, 6-month Study for High Frequency and Chronic Migraine,
Unknown statusNCT06133491
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Multi-Center Unblinded Proof-of-Concept Study of DaxibotulinumtoxinA for Migraine Prevention in High-Frequency and Chronic Migraine: the Standard Paradigm
- Conditions
- Interventions
- Biological: Daxibotulinumtonix A
- Sponsor
- Ki Health Partners. LLC
- Collaborators
- The Los Angeles Headache Center; Revance Therapeutics, Inc.
- Start date
- 2023-10-18
- Primary completion
- 2024-09
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. 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. 2. Subject must be able to read. 3. Male or female subjects, 18 to 75 years of age inclusive. 4. 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. * 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. 5. 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. 6. 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. 7. 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 s…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06133491