Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

• ClinicalTrials.gov Identifier: NCT01833130
• Recruitment Status: Completed
• First Posted: April 16, 2013
• Results First Posted: October 21, 2015
• Last Update Posted: October 21, 2015
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.

Condition or disease	Intervention/treatment	Phase
Chronic Migraine	Biological: OnabotulinumtoxinA; Drug: Normal saline (placebo)	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: April 2013
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: OnabotulinumtoxinA; OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.	Biological: OnabotulinumtoxinA; OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.; Other Names: botulinum toxin Type A; BOTOX®
Placebo Comparator: Placebo (Normal saline); Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.	Drug: Normal saline (placebo); Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score [ Time Frame: Baseline, Week 24 ]
   The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.

Secondary Outcome Measures :

1. Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire [ Time Frame: Baseline, Week 24 ]
   The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SSS subdomain score ranges from 0 (no symptoms) to 100 (more severe symptoms). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SSS.
2. Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire [ Time Frame: Baseline, Week 24 ]
   The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SES subdomain score ranges from 0 (no symptoms) to 12 (all symptoms experienced). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SES.
3. Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire [ Time Frame: Baseline, Week 12, Week 22, Week 24 ]
   The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ADL-I is a subdomain on the ACM-I. The ADL-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ADL-I.
4. Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire [ Time Frame: Baseline, Week 12, Week 22, Week 24 ]
   The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The EMO-I is a subdomain on the ACM-I. The EMO-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EMO-I.
5. Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire [ Time Frame: Baseline, Week 12, Week 22, Week 24 ]
   The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The WS-I is a subdomain on the ACM-I. The WS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the WS-I.
6. Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire [ Time Frame: Baseline, Week 12, Week 22, Week 24 ]
   The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The SOC-I is a subdomain on the ACM-I. The SOC-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the SOC-I.
7. Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire [ Time Frame: Baseline, Week 12, Week 22, Week 24 ]
   The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The LEA-I is a subdomain on the ACM-I. The LEA-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the LEA-I.
8. Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire [ Time Frame: Baseline, Week 12, Week 22, Week 24 ]
   The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The HOS-I is a subdomain on the ACM-I. The HOS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the HOS-I.
9. Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire [ Time Frame: Baseline, Week 12, Week 22, Week 24 ]
   The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ENE-I is a subdomain on the ACM-I. The ENE-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ENE-I.
10. Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire [ Time Frame: Baseline, Week 12, Week 22, Week 24 ]
    The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The COG-I is a subdomain on the ACM-I. The COG-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the COG-I.
11. Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire [ Time Frame: Baseline, Week 12, Week 22, Week 24 ]
    The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The GEN-I is a subdomain on the ACM-I. The GEN-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the GEN-I.
12. Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score [ Time Frame: Baseline, Week 24 ]
    The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
13. Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ) [ Time Frame: Baseline, Week 24 ]
    The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RR domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RR.
14. Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ [ Time Frame: Baseline, Week 24 ]
    The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RP domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RP.
15. Change From Baseline in the Emotional Function (EF) Domain of the MSQ [ Time Frame: Baseline, Week 24 ]
    The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The EF domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EF.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• History of chronic migraine for at least 6 months prior to the screening visit
• Fifteen or more headache days during the 4-week screening period (≥4 headache episodes lasting ≥4 hours and ≥50 % of headache days are migraine)

Exclusion Criteria:

• Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia
• Use of headache prophylaxis medication within 4 weeks of the screening visit
• Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
• Previous use of any botulinum toxin of any serotype for any reason
• Skin infections or acne that would interfere with the injection sites
• Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block treatments, or injection of anesthetics/steroids within 4 weeks of screening.

Contacts and Locations

Locations

United States, California

San Francisco, California, United States

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01833130
• Other Study ID Numbers: GMA-BTX-CM-12-545
• First Posted: April 16, 2013
• Results First Posted: October 21, 2015
• Last Update Posted: October 21, 2015
• Last Verified: September 2015

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents