Migraine Disorders Clinical Trial
Verified date | January 2016 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.
Status | Completed |
Enrollment | 717 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of chronic migraine (=15 days per month with headache lasting 4 hours a day or longer) Exclusion Criteria: - Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis - Headache attributed to another disorder - Infection or skin disorder at injection sites - Previous treatment with botulinum toxin of any serotype for any reason - Anticipated need for botulinum toxin of any type for any reason during the course of the study - Previous participation in any botulinum toxin clinical trial |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Dr. Joseph Frasca | Adelaide | |
Australia | Dr. Con Yiannikas | Burwood | |
Australia | Associate Professor Richard Stark | Melbourne | |
Australia | Richmmond Neurology | Richmond | |
Australia | Associate Professor John O'Sullivan | Spring Hill | |
Korea, Republic of | Hallym University Sacred Heart Hospital | Dongan-gu, Anyang | Anyang Gyeonggi-do |
Korea, Republic of | Kangbuk Samsung Hospital | Jongno-Gu | Seoul |
Korea, Republic of | Seoul St. Mary's Hospital | Jongno-Gu | Seoul |
Korea, Republic of | Seoul Eulji Hospital | Nowon-Gu | Seoul |
Korea, Republic of | Yonsei University Dental Hospital | Seodaemum-Gu | Seoul |
Korea, Republic of | Uijeongbu St. Mary's Hospital | Uijeongbu Si | Gyeonggi-Do |
United States | Dent Neurologic Institute | Amherst | New York |
United States | Mid-Atlantic Headache Institute | Baltimore | Maryland |
United States | Montefiore Medical Center | Bronx | New York |
United States | Ohio Clinical Research Partners, LLC | Canton | Ohio |
United States | Wesley Headache Clinic | Cordova | Tennessee |
United States | Baylor Research Institute | Dallas | Texas |
United States | The Research Center of Southern California, LLC | Encinitas | California |
United States | Advanced Neurosciences Research, LLC | Fort Collins | Colorado |
United States | Headache Wellness Center | Greensboro | North Carolina |
United States | Kaiser Permanente Research Office/Neurology Department | Largo | Maryland |
United States | USC Neurology | Los Angeles | California |
United States | Robbins Headache Clinic | Northbrook | Illinois |
United States | Jefferson University Hospitals | Philadelphia | Pennsylvania |
United States | Renown Institute for Neurosciences | Reno | Nevada |
United States | UCSF Headache Center | San Francisco | California |
United States | Neurological Research Institute | Santa Monica | California |
United States | Arizona Neurological Institute | Scottsdale | Arizona |
United States | Clinvest Research | Springfield | Missouri |
United States | Mercy Health Research | St. Louis | Missouri |
United States | Tampa General Hospital | Tampa | Florida |
United States | Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States, Australia, Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in the Frequency of Headache Days | Baseline, Week 108 | No | |
Secondary | Change from Baseline in the Frequency of Headache Days | Baseline, Week 60 | No | |
Secondary | Change from Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score | Baseline, Week 60, Week 108 | No |
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