Migraine DisordersPhase 3NCT03193346
BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Participants With Chronic Migraine
A Phase 3 study testing botulinum toxin Type A in people with Migraine Disorders, run by Allergan.
Trial summary
This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared with placebo as headache prophylaxis in Chinese participants with chronic migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- botulinum toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2017to 25 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic migraine prior to the baseline phase based on the revised criteria for chronic migraine listed in International Classification of Headache Disorders (ICHD)-3 beta (2013)
- Fifteen or more headache days during the 4-week baseline phase, with each day consisting of 4 or more hours of continuous headache
- Routine non-headache medications of stable dose and regimen for at least 1 month prior to the start of screening.
Who cannot join
- Participants diagnosed with any of the following headache disorders: Familial hemiplegic migraine, Sporadic hemiplegic migraine, Migraine with brainstem aura, Migrainous infarction, Chronic tension-type headache, Hypnic headache, Hemicrania continua, New daily-persistent headache and Recurrent painful ophthalmoplegic neuropathy
- Participants with a confirmed history of medication overuse headache
- Participants with a diagnosis of retinal migraine, persistent aura without infarction or migraine-triggered seizure
- Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
- Use of any headache prophylactic medication within 28 days prior to the start of the screening
- Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
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- Participants with a known or suspected Temporomandibular Disorder (TMD), including pain in or around the Temporomandibular Joint (TMJ)
- Participants with a concurrent diagnosis of fibromyalgia
- Previous treatment with botulinum toxin therapy for any reason, or immunization to any botulinum toxin serotype
- Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, nociceptive trigeminal inhibition or occipital nerve block treatments, or injection of anesthetics or steroids into the study target muscles within 28 days prior to the start of the screening
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared with placebo as headache prophylaxis in Chinese participants with chronic migraine.
- Conditions
- Migraine Disorders
- Being tested
- botulinum toxin Type A, placebo (sodium chloride 0.9 mg)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin Type ABiological
Also called BOTOX®, onabotulinumtoxinA
Botulinum toxin Type A (BOTOX®) 155U to 195U IM injections in head/neck areas.
placebo (sodium chloride 0.9 mg)Drug
Placebo matching BOTOX® [Sodium chloride 0.9 mg] IM injections in head/neck areas.
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® | Experimental | BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections in head/neck areas at Day 0 and Week 12. Receives: Biological: botulinum toxin Type A |
| Placebo | Placebo comparator | Placebo matching BOTOX® [Sodium chloride 0.9 milligrams (mg)] IM injections in head/neck areas at Day 0 and Week 12. Receives: Drug: placebo (sodium chloride 0.9 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Week 24. A headache day was defined as a calendar day [00:00 to 23:59] for which the participant reported ≥ 4 continuous hours of headache per patient diary.
Measured: Baseline, Week 24
Secondary outcomes (4)
Change from Baseline in the Frequency of Headache Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Weeks 4, 8, 12, 16 and 20. A headache day was defined as a calendar day [00:00 to 23:59] for which the participant reported ≥ 4 continuous hours of headache per patient diary.
Measured: Baseline, Weeks 4, 8, 12, 16 and 20
Change from Baseline in the Frequency of Migraine/Probable Migraine Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of migraine or probable migraine episodes during the 28-day period ending with Weeks 4, 8, 12, 16, 20 and 24. A Migraine or Probable Migraine day was defined as a calendar day [00:00 to 23:59] for which the patient reported ≥ 4 continuous hours of a migraine or probable migraine episode as per the patient diary.
Measured: Baseline, Weeks 4, 8, 12, 16, 20 and 24.
Change from Baseline in the Number of Moderate/Severe Headache Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28 day period ending with Weeks 4, 8, 12, 16, 20 and 24. A moderate/severe headache day is defined as a day (00:00 to 23:59) when a participant reported 4 or more continuous hours of headache and reported a maximum severity of moderate or severe per patient diary among all headache episodes that occurred on that day.
Measured: Baseline, Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in the total cumulative hours of headache days during the 28-day period ending with Weeks 4, 8, 12, 16, 20 and 24. A headache day is defined as a day (00:00 to 23:59) with 4 or more continuous hours of headache per patient diary.
Measured: Baseline, Weeks 4, 8, 12, 16, 20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start3 Jul 2017 (estimated)
- Primary completion25 Mar 2021 (estimated)
- Study completion25 Mar 2021 (estimated)
Why it stopped: Corporation Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arlene Lum, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193346
- Sponsor's protocol ID
- 1313-301-008
- Status last verified
- Jul 2017
- First submitted
- 19 Jun 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
- ClinicalTrials.gov ID
- NCT03193346
- Acronym / sponsor ID
- 1313-301-008
- Conditions
- Migraine Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Corporation Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2017 (estimated)
- Primary completion
- 25 Mar 2021 (estimated)
- Study completion
- 25 Mar 2021 (estimated)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared with placebo as headache prophylaxis in Chinese participants with chronic migraine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOTOX® | Experimental | Biological: botulinum toxin Type ABOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections in head/neck areas at Day 0 and Week 12. |
| Placebo | Placebo comparator | Drug: placebo (sodium chloride 0.9 mg)Placebo matching BOTOX® [Sodium chloride 0.9 milligrams (mg)] IM injections in head/neck areas at Day 0 and Week 12. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic migraine prior to the baseline phase based on the revised criteria for chronic migraine listed in International Classification of Headache Disorders (ICHD)-3 beta (2013)
- Fifteen or more headache days during the 4-week baseline phase, with each day consisting of 4 or more hours of continuous headache
- Routine non-headache medications of stable dose and regimen for at least 1 month prior to the start of screening.
Key exclusion criteria (11 listed)
- Participants diagnosed with any of the following headache disorders: Familial hemiplegic migraine, Sporadic hemiplegic migraine, Migraine with brainstem aura, Migrainous infarction, Chronic tension-type headache, Hypnic headache, Hemicrania continua, New daily-persistent headache and Recurrent painful ophthalmoplegic neuropathy
- Participants with a confirmed history of medication overuse headache
- Participants with a diagnosis of retinal migraine, persistent aura without infarction or migraine-triggered seizure
- Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
- Use of any headache prophylactic medication within 28 days prior to the start of the screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin Type AAlso: BOTOX®, onabotulinumtoxinABotulinum toxin Type A (BOTOX®) 155U to 195U IM injections in head/neck areas. | Biological | BOTOX® |
| placebo (sodium chloride 0.9 mg)Placebo matching BOTOX® [Sodium chloride 0.9 mg] IM injections in head/neck areas. | Drug | Placebo |
Primary outcome
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24
Time frame: Baseline, Week 24
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Week 24. A headache day was defined as a calendar day [00:00 to 23:59] for which the participant reported ≥ 4 continuous hours of headache per patient diary.
4 secondary outcomes
Change from Baseline in the Frequency of Headache Days during 28-Day Period
Time frame: Baseline, Weeks 4, 8, 12, 16 and 20
Change from Baseline in the Frequency of Migraine/Probable Migraine Days during 28-Day Period
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24.
Change from Baseline in the Number of Moderate/Severe Headache Days during 28-Day Period
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day Period
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene Lum study director
Allergan
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing botulinum toxin Type A in people with Migraine Disorders, run by Allergan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.