Clinical Review Report

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OnabotulinumtoxinA for Injection (Botox): For the Prophylaxis of Headaches in Adults With Chronic Migraine (≥ 15 Days per Month With Headache Lasting 4 Hours a Day or Longer) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Jul.

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OnabotulinumtoxinA for Injection (Botox): For the Prophylaxis of Headaches in Adults With Chronic Migraine (≥ 15 Days per Month With Headache Lasting 4 Hours a Day or Longer) [Internet].

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Clinical Review Report

Drug	onabotulinumtoxinA for injection (Botox)
Indication	For the prophylaxis of headaches in adults with chronic migraine (≥ 15 days per month with headache lasting 4 hours a day or longer).
Listing request	Prophylaxis of headaches in adults with chronic migraine (≥ 15 days per month with headache lasting 4 hours a day or longer) who have failed (i.e., lack of efficacy, intolerance, or clinical contraindication) ≥ 3 prior oral prophylactic medications. Patients who have not obtained an adequate treatment response (≥ 30% reduction in days of headache per month) after 2 treatment cycles should be discontinued from further therapy.
Manufacturer	Allergan Inc.

ABBREVIATIONS

EXECUTIVE SUMMARY

1. INTRODUCTION

2. OBJECTIVES AND METHODS

3. RESULTS

4. DISCUSSION

5. CONCLUSIONS

APPENDIX 1 PATIENT INPUT SUMMARY

APPENDIX 2 LITERATURE SEARCH STRATEGY

APPENDIX 3 EXCLUDED STUDIES

APPENDIX 4 DETAILED OUTCOME DATA

APPENDIX 5 VALIDITY OF OUTCOME MEASURES

APPENDIX 6 SUMMARY OF OPEN-LABEL EXTENSION PHASE OF STUDY 079 AND STUDY 080

REFERENCES

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Bookshelf ID: NBK344307

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OnabotulinumtoxinA for Injection (Botox): For the Prophylaxis of Headaches in Adults With Chronic Migraine (≥ 15 Days per Month With Headache Lasting 4 Hours a Day or Longer) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Jul. Clinical Review Report.
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