Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine

NCT02037425 | Completed Phase 4 Results

• 1 other identifier: 13-002AL
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Migraine

Keywords

Chronic Migraine; onabotulinumtoxinA; Headache; Migraine; Neuronal regrowth; Botox

Outcome Measures

Primary Outcomes (2)

• Subject Global Impression of Change

  Changes in the Subject's Global Impression of Change (SGIC) measured at weeks 12, 24, and 36 for Groups A, B, and C. Subject global impression of change was measured on a 7 point scale with 0 being Very Much Worse and 7 Very Much Improved.

  Weeks 12, 24, and 36 Post Randomization

• Duration of onabotulinumtoxinA Over 3 Injection Cycles in Groups A, B, and C

  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 during each period (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Duration of response is defined as a 30% reduction in the number of headache days compared to baseline.

  From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days

Secondary Outcomes (10)

• Headache Days

  From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days

• Migraine Disability Assessment Scale (MIDAS)

  Baseline, Week 12, Week 24, and Week 36 Post Randomization

• Social Readjustment Rating Scale (SRRS)

  Baseline, Week 12, Week 24, and Week 36 Post Randomization

• Physician Global Impression of Change (PGIC)

  Week 12, Week 24, and Week 36 Post Randomization

• Beck Depression Inventory II (BDI-II)

  Baseline, Week 12, Week 24, and Week 36 Post Randomization

Other Outcomes (1)

• Neuronal Regrowth

  Baseline & Week 12 Post Randomization

Study Arms (1)

onabotulinumtoxinA

OTHER

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).

Drug: onabotulinumtoxinA

Interventions

onabotulinumtoxinA DRUG

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).

Also known as: Botox

onabotulinumtoxinA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cady, Roger, M.D.: lead
• Allergan: collaborator

Study Sites (1)

Clinvest/A Division of Banyan Group, Inc.

Springfield, Missouri, 65807, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Roger Cay, M.D.
• Organization: Clinvest/A Division of Banyan Group Inc.

rcady@banyangroupinc.com

417-883-7889

Study Officials

• Roger K Cady, M.D.

  Clinvest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 11, 2016
• Results First Posted: March 8, 2016

Record last verified: 2016-07

Locations

US (1)