Migraine DisordersPhase 1/2NCT02259075
Botox Injection in Treatment of Chronic Migraine
A Phase 1/2 study testing Botulinum Toxin Type A in people with Migraine Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Botulinum Toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2015to Mar 2016
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed and written consent
- Chronic migraine with or without aura defined in International Classification of Headache Disorders (ICHD)-3 criteria
- Failed at least 3 oral migraine prophylactic treatments
- Duration of migraine at least 1 year before inclusion
- Start of migraine before participant turned 50 years
- Participant can make a distinction between migraine and other types of headache
Who cannot join
- If the criteria for medication-overuse headache (MOH) is fulfilled
- Heart or lung disease
- Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
- Psychiatric illness that hinders participation in the study
- Known pregnancy or breast feeding
- Inadequate use of contraceptives
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- Overuse or abuse of opioids
- Abuse of medications, narcotics or alcohol
- Anomalies which hinder or impede the used method of injection
- Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication
- Treatment with medication that can interact with botulinum toxin type A
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Neuroscience, Norwegian University of Science and Technology
Trondheim
About this study
Official title: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect.
The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.
Read more
The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail.
The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.
- Conditions
- Migraine Disorders
- Being tested
- Botulinum Toxin Type A
- Keywords
- Migraine with aura, Migraine without aura, Headache disorders, Botulinum Toxin Type A, Sphenopalatine Ganglion Block, Autonomic Nerve Block
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox, BTA
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin | Experimental | The patients will be injected with 25 IU of Botulinum Toxin Type A towards both the right and left sphenopalatine ganglion, a total of 50 IU. Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events and number of participants with adverse events
Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.
Measured: For the follow-up period of 3 months
Number of headache days with moderate or severe intensity
measured from week 5 to week 8, in total during 4 weeks
Measured: 5-8 weeks
Secondary outcomes (4)
Number of reponders
response is defined as ≥ 50% reduction in number of headache days with moderate or severe intensity per 4 weeks (week 1-4, week 5-8, week 9-12)
Measured: 12 weeks
Days with moderate or severe headache per 4 weeks
week 1-4, week 5-8, week 9-12
Measured: 12 weeks
Days without headache per 4 weeks
week 1-4, week 5-8, week 9-12
Measured: 12 weeks
Hours with headache of moderate or severe headache per 4 weeks
week 1-4, week 5-8, week 9-12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Erling A Tronvik, PhD, MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259075
- Sponsor's protocol ID
- BTACM2014
- Other IDs
- 2014-001852-43, 2014
- Status last verified
- May 2016
- First submitted
- 3 Oct 2014
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bratbak DF, Nordgard S, Stovner LJ, Linde M, Dodick DW, Aschehoug I, Folvik M, Tronvik E. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine. Cephalalgia. 2017 Apr;37(4):356-364. doi: 10.1177/0333102416648328. Epub 2016 May 6.
PubMed 27154997
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
- ClinicalTrials.gov ID
- NCT02259075
- Acronym / sponsor ID
- BTACM2014
- Conditions
- Migraine Disorders
- Keywords
- Migraine with aura, Migraine without aura, Headache disorders, Botulinum Toxin Type A, Sphenopalatine Ganglion Block, Autonomic Nerve Block
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Oct 2014 (estimated)
- 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.
Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect.
The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.
The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail.
The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin | Experimental | Drug: Botulinum Toxin Type AThe patients will be injected with 25 IU of Botulinum Toxin Type A towards both the right and left sphenopalatine ganglion, a total of 50 IU. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed and written consent
- Chronic migraine with or without aura defined in International Classification of Headache Disorders (ICHD)-3 criteria
- Failed at least 3 oral migraine prophylactic treatments
- Duration of migraine at least 1 year before inclusion
- Start of migraine before participant turned 50 years
Key exclusion criteria (11 listed)
- If the criteria for medication-overuse headache (MOH) is fulfilled
- Heart or lung disease
- Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
- Psychiatric illness that hinders participation in the study
- Known pregnancy or breast feeding
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, BTA | Drug | Botulinum Toxin |
Primary outcome
Number of adverse events and number of participants with adverse events
Time frame: For the follow-up period of 3 months
Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.
Number of headache days with moderate or severe intensity
Time frame: 5-8 weeks
measured from week 5 to week 8, in total during 4 weeks
4 secondary outcomes
Number of reponders
Time frame: 12 weeks
Days with moderate or severe headache per 4 weeks
Time frame: 12 weeks
Days without headache per 4 weeks
Time frame: 12 weeks
Hours with headache of moderate or severe headache per 4 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Results publication: PubMed 27154997Bratbak DF, Nordgard S, Stovner LJ, Linde M, Dodick DW, Aschehoug I, Folvik M, Tronvik E. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine. Cephalalgia. 2017 Apr;37(4):356-364. doi: 10.1177/0333102416648328. Epub 2016 May 6.
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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.
Erling A Tronvik, PhD, MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Botulinum Toxin Type A in people with Migraine Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
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 6 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: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of adverse events and number of participants with adverse events (time frame: For the follow-up period of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02259075, which also lists 1 linked publication.
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 23 May 2016.