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Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine

CompletedPhase 4NCT02037425
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)

To obtain a patient specific understanding of response to treatment with onabotulinumtoxinA by collecting and correlating pre and post treatment subject specific history, clinical outcomes, and histological changes.

Study details

Official title
Exploratory Study of the Natural History, Clinical Outcomes, and Neuronal Endplate Changes in Subjects Reporting Short Duration vs. Long Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine
Interventions
  • Drug: onabotulinumtoxinA
Sponsor
Cady, Roger, M.D.
Collaborators
Allergan
Start date
2014-04
Primary completion
2015-09
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * male or female 18 years or older. * able to read, understand, and sign the informed consent. * a negative urine pregnancy test at visit 1, if female, and of childbearing potential. Note: If female of childbearing potential, subject must agree to maintain true abstinence or use one of the listed methods of birth control for the duration of the study: hormonal contraceptive, intrauterine device (IUD), condoms, diaphragm, and/or have a male partner who has undergone a successful vasectomy. The use of barrier contraceptive (condom or diaphragm) should always be supplemented with the use of a spermicide. Note: To be considered not of childbearing potential, subject must be 6 weeks post-surgical bilateral oophorectomy, hysterectomy, bilateral tubal ligation, postmenopausal for at least one year. * at least a one year history of migraine * history of chronic migraine (with or without aura) according to the criteria of the International Classification of Headache Disorders (ICHD)-3 for at least 3 months prior to enrollment (Appendix I) * able to differentiate migraine headache from any other headache they may experience (e.g., cluster headache) * onset of migraine before age 50 * willing to provide responses to questionnaires and complete the online diary. * if taking migraine preventive(s), be on a stable dose of the preventive medication for at least 30 days prior to screening * concomitant medication dosages approved by the investigator * email and internet access for completion of online diary Exclusion Criteria: * previously used onabotulinumtoxinA as a migraine preventative or has used onabotulinumtoxinA for any other reason during the prior year * female who is pregnant, planning to become pregnant during the study period, breast feeding, or is of childbearing potential and not practicing a reliable form of birth control * headache disorders outside ICHD-3 defined chronic migraine that cannot be easily distinguished from CM (Appendix I) * evidence of underlying pathology contributing to their headaches * any medical condition that may increase their risk with exposure to BTX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function * profound atrophy or weakness of muscles in the target areas of injection * skin conditions or infections at any of the injection sites * allergy or sensitivities to any component of the tes…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02037425