Results First Posted : January 6, Last Update Posted : January 6, Study Description. 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.
MedlinePlus related topics: Botox Headache Migraine. Drug Information available for: OnabotulinumtoxinA Abobotulinumtoxina. FDA Resources. Arms and Interventions. Participants received U of onabotulinumtoxinA approximately every 12 weeks for weeks. Outcome Measures. The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning ability to carry out usual activities ; social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Drug: Normal Saline Placebo normal saline injected into protocol-specified areas on Day 1. Biological: onabotulinumtoxinA OnabotulinumtoxinA injected into protocol-specified areas on Day 1. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Scores range from 1 to 7, from normal 1, not at all ill to among the most extremely ill patients 7. The total scores range from 0 to A higher total score indicates more severe depression. 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.
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Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Listing a study does not mean it has been evaluated by the U. Federal Government. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.
Shannon Humphrey, Inc. More Information. Dermatol Surg. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Forehead Rhytides Glabellar Rhytides. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :.
Actual Study Completion Date :. Experimental: OnabotulinumtoxinA OnabotulinumtoxinA injected into the protocol-specified areas on Day 1.
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