BOTOX® Prophylaxis in Patients With Chronic Migraine
This study is currently recruiting participants.
Verified November 2012 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01432379
First received: September 9, 2011
Last updated: November 28, 2012
Last verified: November 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 9, 2011 | ||||
| Last Updated Date | November 28, 2012 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of Dysphagia [ Time Frame: 64 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01432379 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Incidence of Worsening or Intractable Migraine [ Time Frame: 64 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | BOTOX® Prophylaxis in Patients With Chronic Migraine | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with Chronic Migraine |
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| Condition ICMJE | Migraine Disorders | ||||
| Intervention ICMJE | Biological: botulinum toxin Type A
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year
Other Name: BOTOX® |
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| Study Group/Cohort (s) | botulinum toxin Type A
botulinum toxin Type A
Intervention: Biological: botulinum toxin Type A |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | April 2015 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany, Spain, Sweden, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01432379 | ||||
| Other Study ID Numbers ICMJE | 191622-110 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Allergan | ||||
| Study Sponsor ICMJE | Allergan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Allergan | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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