Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Cady, Roger, M.D.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Cady, Roger, M.D.
ClinicalTrials.gov Identifier:
NCT02037425
First received: January 14, 2014
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chronic Migraine
Drug: onabotulinumtoxinA
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cady, Roger, M.D.:

Primary Outcome Measures:
  • Subject Global Impression of Change [ Time Frame: From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Changes in the Subject's Global Impression of Change (SGIC) measured at weeks 12, 24, and 36 for Groups A, B, and C.

  • Duration of onabotulinumtoxinA Over 3 Injection Cycles in Groups A, B, and C [ Time Frame: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Compare the duration of onabotulinumtoxinA response through the 3 injection cycles of the study for Groups A, B, and C as measured by headache days per month.


Secondary Outcome Measures:
  • Headache Days [ Time Frame: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Comparison of headache days per month over each injection cycle between Groups A, B, and C. Subjects will remain in their assigned groups based on assessment at 12 weeks

  • Migraine Disability Assessment Scale (MIDAS) [ Time Frame: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Comparison between Group A, B, and C for MIDAS scores measured at baseline and weeks 12, 24, and 36.

  • Social Readjustment Rating Scale (SRRS) [ Time Frame: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Comparison between Group A, B, and C for SRRS scores measured at baseline and weeks 12, 24, and 36.

  • Physician Global Impression of Change (PGIC) [ Time Frame: From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Comparison between Group A, B, and C for PGIC scores measured at baseline and weeks 12, 24, and 36.

  • Beck Depression Inventory II (BDI-II) [ Time Frame: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Comparison between Group A, B, and C for BDI-II scores measured at baseline and weeks 12, 24, and 36.

  • State-Trait Anxiety Inventory (STAI) [ Time Frame: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Comparison between Group A, B, and C for STAI scores measured at baseline and weeks 12, 24, and 36.

  • Sleep Quality Questionnaire [ Time Frame: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Comparison between Group A, B, and C for sleep quality scores measured at baseline and weeks 12, 24, and 36.

  • Acute Medication Usage [ Time Frame: From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Comparison of acute medication usage between Groups A, B, and C.

  • Consistency of Response to onbotulinumtoxinA Over Three Injection Cycles [ Time Frame: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Compare the consistency of duration of onabotulinumtoxinA response by the group assignment at 12 weeks to assessments at 24, and 36 weeks evaluations.

  • Neuronal Regrowth [ Time Frame: From day 29 (first day of injection cycle 1) to day 197 (84th day of injection cycle 2) plus or minus 6 days ] [ Designated as safety issue: No ]
    Correlate neuronal regrowth in the skin biopsies with duration of benefit of onabotulinumtoxinA

  • Duration of onabotulinumtoxinA Over 3 Injection Cycles [ Time Frame: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days ] [ Designated as safety issue: No ]
    Compare duration of benefit of onabotulinumtoxinA response through 3 injection cycles for Groups A, B, and C as measured by headache days per week.


Estimated Enrollment: 36
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
onabotulinumtoxinA Drug: onabotulinumtoxinA
BOTOX® (Formulation Number 9060X) contains 200 International Units (IU) of Clostridium botulinum Toxin Type A, reconstituted with 4 cc of normal saline providing 5 units per 0.1 cc. At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
Other Name: Botox

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 test medication
  • in the opinion of the investigator, has an active major psychiatric disorder including substance abuse and/or substance dependence within the last 12 months as determined by the investigator.
  • Medication Overuse Headache as defined by ICHD-3 criteria for opioid or butalbital containing products (Appendix II)
  • planning or requiring surgery during the study
  • a history of poor compliance with medical treatment
  • currently participating in an investigational drug study or has participated in an investigational drug study within the previous 30 days of the screening visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037425

Contacts
Contact: Jeanne G Tarrasch, BSN, RN 417-841-3673 jtarrasch@clinvest.com
Contact: Heather R Manley, MS, LPC 417-841-3664 hmanley@clinvest.com

Locations
United States, Missouri
Clinvest/A Division of Banyan Group, Inc. Recruiting
Springfield, Missouri, United States, 65807
Contact: Alice Oh, LPN    417-841-3681    aoh@clinvest.com   
Contact: Sami Louzader, BA, RN    417-841-3659    slouzader@clinvest.com   
Principal Investigator: Roger K Cady, M.D.         
Sub-Investigator: Kent Dexter, M.D.         
Sponsors and Collaborators
Cady, Roger, M.D.
Allergan
Investigators
Principal Investigator: Roger K Cady, M.D. Clinvest/A Division of Banyan Group,Inc.
  More Information

No publications provided

Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT02037425     History of Changes
Other Study ID Numbers: 13-002AL
Study First Received: January 14, 2014
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cady, Roger, M.D.:
Chronic Migraine
onabotulinumtoxinA
Headache
Migraine
Neuronal regrowth
Botox

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014