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This is a 60 week study including a double-blind phase followed by an open-label extension phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A | Experimental | Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections. |
|
| Placebo (saline) | Placebo Comparator | Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Biological | Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Headache Episodes | Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Headache Days | Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache | Baseline, Week 24 |
| Change in Frequency of Acute Headache Pain Medication Intakes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle | Washington | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33026631 | Derived | Diener HC, Dodick DW, Lipton RB, Manack Adams A, DeGryse RE, Silberstein SD. Benefits Beyond Headache Days With OnabotulinumtoxinA Treatment: A Pooled PREEMPT Analysis. Pain Ther. 2020 Dec;9(2):683-694. doi: 10.1007/s40122-020-00198-w. Epub 2020 Oct 7. | |
| 33026630 | Derived | Silberstein SD, Diener HC, Dodick DW, Manack Adams A, DeGryse RE, Lipton RB. The Impact of OnabotulinumtoxinA vs. Placebo on Efficacy Outcomes in Headache Day Responder and Nonresponder Patients with Chronic Migraine. Pain Ther. 2020 Dec;9(2):695-707. doi: 10.1007/s40122-020-00199-9. Epub 2020 Oct 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections. |
| FG001 | Placebo (Saline) | Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind Phase (DB) |
| |||||||||||||
| Open-Label Phase (OL) |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A | Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Frequency of Headache Episodes | Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours. | Intent to Treat | Posted | Mean | Standard Deviation | Headache Episodes | Baseline, Week 24 |
|
Not provided
For SAEs/AEs, the Total # Participants at Risk for the Botulinum toxin type A arm includes ALL patients in the safety population who received Botulinum toxin type A in the Double-Blind and Open-Label phases. The total # Participants at Risk for the Placebo arm includes ONLY Double-blind Phase patients in the safety population who received Placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin Type A | Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | (714) 246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
| Placebo (saline) | Other | Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections. |
|
Mean change from baseline in frequency (number) of acute headache pain medication intakes during the 28 day period ending with Week 24. Medication intakes defined as the number of times a patient took acute headache pain medication regardless of dose or type/number of medications taken at the same time. |
| Baseline, Week 24 |
| Change in Frequency of Migraine/Probable Migraine Headache Days | Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting ICHD-II criteria for migraine or probable migraine. | Baseline, Week 24 |
| Change in Frequency of Migraine/Probable Migraine Headache Episodes | Mean change from baseline in frequency (number) of migraine/probable migraine headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours and met ICHD-II criteria for migraine or probable migraine. | Baseline, Week 24 |
| Markham |
| Ontario |
| Canada |
| 31112399 | Derived | Dodick DW, Silberstein SD, Lipton RB, DeGryse RE, Adams AM, Diener HC. Early onset of effect of onabotulinumtoxinA for chronic migraine treatment: Analysis of PREEMPT data. Cephalalgia. 2019 Jul;39(8):945-956. doi: 10.1177/0333102418825382. Epub 2019 May 21. |
| 25500317 | Derived | Silberstein SD, Dodick DW, Aurora SK, Diener HC, DeGryse RE, Lipton RB, Turkel CC. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry. 2015 Sep;86(9):996-1001. doi: 10.1136/jnnp-2013-307149. Epub 2014 Dec 12. |
| 25080874 | Derived | Rendas-Baum R, Yang M, Varon SF, Bloudek LM, DeGryse RE, Kosinski M. Validation of the Headache Impact Test (HIT-6) in patients with chronic migraine. Health Qual Life Outcomes. 2014 Aug 1;12:117. doi: 10.1186/s12955-014-0117-0. |
| 21883197 | Derived | Aurora SK, Winner P, Freeman MC, Spierings EL, Heiring JO, DeGryse RE, VanDenburgh AM, Nolan ME, Turkel CC. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73. doi: 10.1111/j.1526-4610.2011.01990.x. Epub 2011 Aug 29. |
| 20487038 | Derived | Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010 Jun;50(6):921-36. doi: 10.1111/j.1526-4610.2010.01678.x. Epub 2010 May 7. |
| NOT COMPLETED |
|
| Placebo (Saline) |
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections. |
|
|
| Secondary | Change in Frequency of Headache Days | Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache | Intent to Treat | Posted | Mean | Standard Deviation | Headache Days | Baseline, Week 24 |
|
|
|
| Secondary | Change in Frequency of Acute Headache Pain Medication Intakes | Mean change from baseline in frequency (number) of acute headache pain medication intakes during the 28 day period ending with Week 24. Medication intakes defined as the number of times a patient took acute headache pain medication regardless of dose or type/number of medications taken at the same time. | Intent to Treat | Posted | Mean | Standard Deviation | Medication Intakes | Baseline, Week 24 |
|
|
|
| Secondary | Change in Frequency of Migraine/Probable Migraine Headache Days | Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting ICHD-II criteria for migraine or probable migraine. | Intent to Treat | Posted | Mean | Standard Deviation | Migraine/Probable Migraine Headache Days | Baseline, Week 24 |
|
|
|
| Secondary | Change in Frequency of Migraine/Probable Migraine Headache Episodes | Mean change from baseline in frequency (number) of migraine/probable migraine headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours and met ICHD-II criteria for migraine or probable migraine. | Intent to Treat | Posted | Mean | Standard Deviation | Migraine/Prob Migraine Headache Episodes | Baseline, Week 24 |
|
|
|
| 42 |
| 624 |
| 215 |
| 624 |
| EG001 | Placebo (Saline) | Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections. | 8 | 334 | 64 | 334 |
| Non-cardiac chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Invertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Appendicitis perforated | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cervical cord compression | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Migraine without aura | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Parvovirus B19 serology positive | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Rocky mountain spotted fever | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Status migrainosus | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Carotid artery thrombosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Gastrointestinal stoma complications | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Peridiverticular abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Reflux gastritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Substance abuse | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Temporal arteritis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ulcer haemorrhage | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D009422 | Nervous System Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |