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

NCT01833130 | Completed Phase 4 Results

• 1 other identifier: GMA-BTX-CM-12-545
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score

  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.

  Baseline, Week 24

Secondary Outcomes (15)

• Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire

  Baseline, Week 24

• Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire

  Baseline, Week 24

• Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire

  Baseline, Week 12, Week 22, Week 24

• Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire

  Baseline, Week 12, Week 22, Week 24

• Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire

  Baseline, Week 12, Week 22, Week 24

Study Arms (2)

OnabotulinumtoxinA

EXPERIMENTAL

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

Placebo (Normal saline)

PLACEBO COMPARATOR

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)

Interventions

OnabotulinumtoxinA BIOLOGICAL

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.

Also known as: botulinum toxin Type A, BOTOX®

OnabotulinumtoxinA

Normal saline (placebo) DRUG

Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

Placebo (Normal saline)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

San Francisco, California, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Saline Solution

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Director,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 21, 2015
• Results First Posted: October 21, 2015

Record last verified: 2015-09

Locations

US (1)