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A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

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ClinicalTrials.gov Identifier: NCT00156910
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : December 7, 2010
Last Update Posted : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Biological: Botulinum Toxin Type A
Other: Placebo (saline)
Enrollment 679
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin Type A Placebo (Saline)
Hide Arm/Group Description 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. 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.
Period Title: Double-Blind Phase (DB)
Started 341 338
Completed 296 [1] 295 [1]
Not Completed 45 43
[1]
Completed Week 24
Period Title: Open-Label Phase (OL)
Started 285 [1] 286 [2]
Completed 252 231
Not Completed 33 55
[1]
Number of DB Botulinum toxin type A patients who rolled into OL phase
[2]
Number of DB Placebo patients who rolled into OL Phase
Arm/Group Title Botulinum Toxin Type A Placebo (Saline) Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 341 338 679
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 341 participants 338 participants 679 participants
< 40years 144 128 272
>= 40 years 197 210 407
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 341 participants 338 participants 679 participants
Female
304
  89.1%
290
  85.8%
594
  87.5%
Male
37
  10.9%
48
  14.2%
85
  12.5%
1.Primary Outcome
Title Change in Frequency of Headache Episodes
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Botulinum Toxin Type A Placebo (Saline)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 341 338
Mean (Standard Deviation)
Unit of Measure: Headache Episodes
Baseline 12.3  (5.23) 13.4  (5.71)
Change from Baseline at Week 24 -5.2  (5.27) -5.3  (5.85)
2.Secondary Outcome
Title Change in Frequency of Headache Days
Hide Description 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
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Botulinum Toxin Type A Placebo (Saline)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 341 338
Mean (Standard Deviation)
Unit of Measure: Headache Days
Baseline 20.0  (3.73) 19.8  (3.71)
Change from Baseline at Week 24 -7.8  (6.57) -6.4  (6.69)
3.Secondary Outcome
Title Change in Frequency of Acute Headache Pain Medication Intakes
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Botulinum Toxin Type A Placebo (Saline)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 341 338
Mean (Standard Deviation)
Unit of Measure: Medication Intakes
Baseline 29.1  (19.27) 30.4  (22.29)
Change from Baseline at Week 24 -10.3  (18.67) -10.4  (18.54)
4.Secondary Outcome
Title Change in Frequency of Migraine/Probable Migraine Headache Days
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Botulinum Toxin Type A Placebo (Saline)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 341 338
Mean (Standard Deviation)
Unit of Measure: Migraine/Probable Migraine Headache Days
Baseline 19.1  (4.04) 19.1  (4.05)
Change from Baseline at Week 24 -7.6  (6.51) -6.1  (6.78)
5.Secondary Outcome
Title Change in Frequency of Migraine/Probable Migraine Headache Episodes
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Botulinum Toxin Type A Placebo (Saline)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 341 338
Mean (Standard Deviation)
Unit of Measure: Migraine/Prob Migraine Headache Episodes
Baseline 11.5  (5.06) 12.7  (5.72)
Change from Baseline at Week 24 -4.8  (5.06) -4.9  (5.74)
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Botulinum Toxin Type A Placebo (Saline)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Botulinum Toxin Type A Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Toxin Type A Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%)
Total   42/624 (6.73%)   8/334 (2.40%) 
Cardiac disorders     
Atrial fibrillation  1  1/624 (0.16%)  0/334 (0.00%) 
Cardiac arrest  1  1/624 (0.16%)  0/334 (0.00%) 
Angina pectoris  1  1/624 (0.16%)  0/334 (0.00%) 
Congenital, familial and genetic disorders     
Atrial septal defect  1  1/624 (0.16%)  0/334 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  1/624 (0.16%)  1/334 (0.30%) 
Intestinal obstruction  1  1/624 (0.16%)  1/334 (0.30%) 
Small intestinal obstruction  1  2/624 (0.32%)  0/334 (0.00%) 
Vomiting * 1  1/624 (0.16%)  1/334 (0.30%) 
Abdominal hernia  1  1/624 (0.16%)  0/334 (0.00%) 
Abdominal pain upper * 1  1/624 (0.16%)  0/334 (0.00%) 
Appendicitis perforated  1  1/624 (0.16%)  0/334 (0.00%) 
Irritable bowel syndrome  1  1/624 (0.16%)  0/334 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/624 (0.16%)  0/334 (0.00%) 
Proctitis  1  1/624 (0.16%)  0/334 (0.00%) 
Haematemesis  1  0/624 (0.00%)  1/334 (0.30%) 
Reflux gastritis  1  1/624 (0.16%)  0/334 (0.00%) 
General disorders     
Non-cardiac chest pain  1  3/624 (0.48%)  0/334 (0.00%) 
Chest pain * 1  1/624 (0.16%)  0/334 (0.00%) 
Ulcer haemorrhage  1  0/624 (0.00%)  1/334 (0.30%) 
Hepatobiliary disorders     
Cholecystitis  1  1/624 (0.16%)  0/334 (0.00%) 
Cholecystitis chronic  1  1/624 (0.16%)  0/334 (0.00%) 
Infections and infestations     
Cellulitis * 1  1/624 (0.16%)  0/334 (0.00%) 
Diverticulitis  1  1/624 (0.16%)  0/334 (0.00%) 
Pneumonia  1  1/624 (0.16%)  0/334 (0.00%) 
Pulmonary tuberculosis  1  1/624 (0.16%)  0/334 (0.00%) 
Pyelonephritis  1  1/624 (0.16%)  0/334 (0.00%) 
Rocky mountain spotted fever  1  1/624 (0.16%)  0/334 (0.00%) 
Bronchitis  1  0/624 (0.00%)  1/334 (0.30%) 
Catheter site infection * 1  1/624 (0.16%)  1/334 (0.30%) 
Clostridium difficile colitis  1  1/624 (0.16%)  0/334 (0.00%) 
Gastroenteritis  1  0/624 (0.00%)  1/334 (0.30%) 
Peridiverticular abscess  1  1/624 (0.16%)  0/334 (0.00%) 
Injury, poisoning and procedural complications     
Gastrointestinal stoma complications  1  0/624 (0.00%)  1/334 (0.30%) 
Procedural headache * 1  1/624 (0.16%)  0/334 (0.00%) 
Investigations     
Parvovirus B19 serology positive  1  1/624 (0.16%)  0/334 (0.00%) 
Musculoskeletal and connective tissue disorders     
Invertebral disc protrusion  1  2/624 (0.32%)  0/334 (0.00%) 
Arthralgia * 1  1/624 (0.16%)  0/334 (0.00%) 
Osteoarthritis  1  1/624 (0.16%)  0/334 (0.00%) 
Osteopenia  1  1/624 (0.16%)  0/334 (0.00%) 
Spinal osteoarthritis  1  1/624 (0.16%)  0/334 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  3/624 (0.48%)  0/334 (0.00%) 
Basal cell carcinoma  1  2/624 (0.32%)  1/334 (0.30%) 
Malignant melanoma in situ  1  0/624 (0.00%)  1/334 (0.30%) 
Squamous cell carcinoma  1  1/624 (0.16%)  0/334 (0.00%) 
Nervous system disorders     
Migraine * 1  4/624 (0.64%)  0/334 (0.00%) 
Carotid artery occlusion  1  1/624 (0.16%)  0/334 (0.00%) 
Cerebral infarction  1  1/624 (0.16%)  0/334 (0.00%) 
Cervical cord compression  1  1/624 (0.16%)  0/334 (0.00%) 
Headache * 1  1/624 (0.16%)  0/334 (0.00%) 
Migraine without aura * 1  1/624 (0.16%)  0/334 (0.00%) 
Status migrainosus  1  1/624 (0.16%)  0/334 (0.00%) 
Syncope  1  1/624 (0.16%)  0/334 (0.00%) 
Carotid artery thrombosis  1  1/624 (0.16%)  0/334 (0.00%) 
Spinal cord compression  1  0/624 (0.00%)  1/334 (0.30%) 
Psychiatric disorders     
Major depression  1  1/624 (0.16%)  0/334 (0.00%) 
Substance abuse  1  1/624 (0.16%)  0/334 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/624 (0.16%)  0/334 (0.00%) 
Reproductive system and breast disorders     
Menorrhagia * 1  1/624 (0.16%)  1/334 (0.30%) 
Dysfunctional uterine bleeding * 1  1/624 (0.16%)  0/334 (0.00%) 
Endometrial hyperplasia  1  1/624 (0.16%)  0/334 (0.00%) 
Vascular disorders     
Temporal arteritis  1  0/624 (0.00%)  1/334 (0.30%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Botulinum Toxin Type A Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%)
Total   215/624 (34.46%)   64/334 (19.16%) 
Infections and infestations     
Sinusitis  1  46/624 (7.37%)  17/334 (5.09%) 
Upper respiratory tract infection  1  37/624 (5.93%)  20/334 (5.99%) 
Nasopharyngitis * 1  34/624 (5.45%)  16/334 (4.79%) 
Musculoskeletal and connective tissue disorders     
Neck pain * 1  63/624 (10.10%)  11/334 (3.29%) 
Muscular weakness * 1  35/624 (5.61%)  0/334 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
Phone: (714) 246-4500
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00156910     History of Changes
Other Study ID Numbers: 191622-079
First Submitted: September 7, 2005
First Posted: September 12, 2005
Results First Submitted: November 5, 2010
Results First Posted: December 7, 2010
Last Update Posted: November 18, 2013