A Phase 3 interventional study of Botulinum Toxin Type A and placebo (saline) in Migraine Disorders, sponsored by Allergan. Completed at 6 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-18.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
This is a 60 week study including a double-blind phase followed by an open-label phase.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 705 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: Botulinum Toxin Type A
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.
Other: placebo (saline)
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label 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.
Also known as: BOTOX®
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.
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.
Time frame: Baseline, Week 24
Change in Total Cumulative Hours of Headache Occurring on Headache Days
Mean change from baseline in total cumulative hours of headache occurring on headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day \[00:00 to 23:59\] when the patient reported \>= 4 continuous hours of headache.
Time frame: Baseline, Week 24
Change in Frequency of Moderate/Severe Headache Days
Mean change from baseline in frequency (number) of moderate/severe headache days during the 28 day period ending with Week 24. Those calendar days with \>= 4 continuous hours of headache were selected. As per the patient diary, all headache episodes occurring during those days with a maximum severity of moderate or severe were counted.
Time frame: 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 the ICHD-II criteria for migraine or probable migraine.
Time frame: Baseline, Week 24
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.
Time frame: Baseline, Week 24
Percentage of Patients With Severe HIT-6 Impact Category Scores
Percentage of patients with a severe (60-78) score on the Headache Impact Test (HIT-6) Questionnaire during the 28 day period, ending with Week 24. The HIT-6 consisted of 6 questions about headache and impact on the patient's health and well-being. Answers for each question ranged from 6=Never, 8=Rarely, 10=Sometimes, 11=Very Often, and 13=Always. The total scores ranged from 36-49 (Little or No Impact), 50-55 (Some Impact), 56-59 (Substantial Impact) and 60-78 (Severe Impact).
Time frame: Week 24
| Milestone | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| Started | 347 | 358 |
| Completed | 311 | 334 |
| Not completed | 36 | 24 |
| Milestone | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| Started | 305 | 329 |
| Completed | 261 | 261 |
| Not completed | 44 | 68 |
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.
| Headache Days | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| Baseline | 19.9 ± 3.63 | 19.7 ± 3.65 |
| Change from Baseline at Week 24 | -9.0 ± 6.54 | -6.7 ± 6.67 |
Mean change from baseline in total cumulative hours of headache occurring on headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day \[00:00 to 23:59\] when the patient reported \>= 4 continuous hours of headache.
| Hours | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| Baseline | 296.18 ± 121.043 | 287.20 ± 118.089 |
| Change from Baseline at Week 24 | -132.41 ± 130.216 | -90.01 ± 133.758 |
Mean change from baseline in frequency (number) of moderate/severe headache days during the 28 day period ending with Week 24. Those calendar days with \>= 4 continuous hours of headache were selected. As per the patient diary, all headache episodes occurring during those days with a maximum severity of moderate or severe were counted.
| Moderate/Severe Headache Days | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| Baseline | 18.1 ± 4.03 | 17.7 ± 4.26 |
| Change from Baseline at Week 24 | -8.3 ± 6.37 | -5.8 ± 6.59 |
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 the ICHD-II criteria for migraine or probable migraine.
| Migraine/Probable Migraine Headache Days | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| Baseline | 19.2 ± 3.94 | 18.7 ± 4.05 |
| Change from Baseline at Week 24 | -8.7 ± 6.64 | -6.3 ± 6.71 |
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.
| Headache Episodes | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| Baseline | 12.0 ± 5.27 | 12.7 ± 5.29 |
| Change from Baseline at Week 24 | -5.3 ± 5.12 | -4.6 ± 4.84 |
Percentage of patients with a severe (60-78) score on the Headache Impact Test (HIT-6) Questionnaire during the 28 day period, ending with Week 24. The HIT-6 consisted of 6 questions about headache and impact on the patient's health and well-being. Answers for each question ranged from 6=Never, 8=Rarely, 10=Sometimes, 11=Very Often, and 13=Always. The total scores ranged from 36-49 (Little or No Impact), 50-55 (Some Impact), 56-59 (Substantial Impact) and 60-78 (Severe Impact).
| Percentage of Patients | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| Percentage of Patients With Severe HIT-6 Impact Category Scores | 66.3 | 76.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botulinum Toxin Type A | — | 33/676 (4.9%) | 195/676 (28.8%) |
| Placebo (Saline) | — | 8/358 (2.2%) | 34/358 (9.5%) |
| Event | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| MigraineNervous system disorders | 4/676 | 1/358 |
| PneumoniaInfections and infestations | 3/676 | 1/358 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/676 | 0/358 |
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/676 | 0/358 |
| DepressionPsychiatric disorders | 2/676 | 0/358 |
| CholelithiasisHepatobiliary disorders | 0/676 | 1/358 |
| EndometriosisReproductive system and breast disorders | 0/676 | 1/358 |
| GastroenteritisInfections and infestations | 0/676 | 1/358 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/676 | 1/358 |
| Papillary thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/676 | 1/358 |
| Event | Botulinum Toxin Type A | Placebo (Saline) |
|---|---|---|
| Neck painMusculoskeletal and connective tissue disorders | 61/676 | 8/358 |
| NasopharyngitisInfections and infestations | 47/676 | 14/358 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 47/676 | 2/358 |
| SinusitisInfections and infestations | 40/676 | 10/358 |
| Age, Customized(participants) | Botulinum Toxin Type A | Placebo (Saline) | Total |
|---|---|---|---|
| < 40 years | 149 | 160 | 309 |
| >= 40 years | 198 | 198 | 396 |
| Sex: Female, Male(Participants) | Botulinum Toxin Type A | Placebo (Saline) | Total |
|---|---|---|---|
| Female | 299 | 303 | 602 |
| Male | 48 | 55 | 103 |
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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