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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.
Full description
Recognizing a commitment to evidence-based science as the pathway to optimize clinical outcomes for patients with chronic migraine (CM) we believe this investigator initiated study (IIS) will:
Help clinicians recognize the importance of scheduling patients with CM at intervals not exceeding 12 weeks.
Provide biopsy evidence supporting sensory mechanisms involved in the mechanism of action (MOA) of onabotulinumtoxinA (BTX). This does not exclude potential valuable contributions of denervation of motor neurons, but may support a more balanced and understandable mechanism for BTX in treating CM.
Provide clinicians important educational information for patients to better manage expectations of using BTX in managing CM and answering critical questions such as:
How long does it take for BTX to begin providing a clinical benefit?
What is the expected duration of this benefit?
Provide validation for patients' reports of shorter duration of action of BTX so patients will not be misinterpreted as non-responders to BTX prematurely.
Ascertain if subjects initially reporting short duration of BTX response continue to experience this similar pattern of effect with repeated injection cycles.
Provide the first detailed longitudinal assessment of BTX response.
Correlate the onset and duration of benefit for subjects receiving BTX.
Observe factors predictive of duration of BTX response.
This study proposes to accomplish these goals through an exploratory comparison of the clinical efficacy and natural history of BTX measured at weekly time intervals. Subjects reporting short (<10 weeks) duration of benefit and subjects reporting long (>10 weeks) duration of clinical benefit will provide the primary comparison. Histological examinations (in a subset of subjects) of neuronal changes associated with regeneration of terminal neuronal endplates will be used to support these clinical observations. This study will follow subjects through 3 injection cycles or 36 weeks. Biopsies will be performed on consenting subjects prior to their first and second injection cycles.
Group Assignment
At Visit 3, subjects will be assigned to one of three groups (Groups A, B, C) based on their answers to the following questions:
Subjects will be assigned into 3 groups:
Consistency of subjects' perception of BTX benefit at 12 weeks will be compared to responses at 24 and 36 weeks, though Group assignment will remain as defined at 12 weeks.
This exploratory study will be conducted at the Headache Care Center in Springfield, MO. Thirty-six subjects, 18 years and older with a history of chronic migraine will be enrolled. The study will consist of 5 visits for all subjects.
At Visit 1 (day 1 of baseline) the following study procedures will be performed:
At Visit 2 (day 29 +/- 3 days) the following study procedures will be performed:
At Visit 3 (day 113 +/- 3 days) the following study procedures will be performed:
At Visit 4 (day 197 +/- 3 days) the following study procedures will be performed:
At Visit 5 (day 281 +/- 3 days) the following study procedures will be performed:
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Inclusion criteria
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.
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44 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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