Chronic MigrainePhase 4NCT03919045
Saline Injections for Prophylactic Treatment of Chronic Migraine
A Phase 4 study testing Saline injection in people with Chronic Migraine, run by Göteborg University at 1 site in Sweden.
Trial summary
In this study, the investigators want to investigate whether saline injections in the neck and head muscles can reduce symptoms of chronic migraine. In existing studies, saline injections (used as placebo treatment) have given patients with chronic migraine an average of 7 headache-free days per month. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jun 2019to 21 May 2021
- Phase
- Phase 4
- 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
- Participants must meet the diagnostic criteria for chronic migraine (headache that have occurred on at least 15 days per month, for at least three months. At least eight of the headache episodes must be typical for migraine).
- Participants must be able to understand and give informed consent to participate in the study.
- Participants must be aged 18-65 years.
Who cannot join
- Participants must not suffer from other medical conditions that may affect the outcome of the study, including Horton's headache, temporal arteritis, trigeminal neuralgia, chronic paroxysmal hemi-crania, atypical facial pain and headache of unknown cause.
- Participants must not have medical conditions that require use of drugs that can affect the headache pattern (for example rheumatic disorders).
- Participants must not suffer from malignant diseases.
- Participants must not plan to make changes to existing prophylactic headache medication during the study. Patients may, if already on treatment, choose to continue this throughout the course of the study, or choose to stop the prophylactic treatment at least one week before the start of the baseline period.
- Participants must not have an ongoing patient-doctor contact with the physician giving the injections.
- Participants must not have an ongoing patient-doctor contact with the monitor of the study.
Show all 12Show fewer
- Participants must not have received injection therapy in the face, head or neck muscles (medical or cosmetic) less than three months before the start of the study, nor should they plan such treatment during the course of the study.
- Participants must not be pregnant or plan pregnancy during the course of the study.
- Participants must not breastfeed or plan to do so during the study.
- Participants must not have any contraindications to injection therapy (such as disease with increased bleeding tendency or treatment with certain types of blood thinners).
- Participants must have no difficulty understanding or making themselves understood in Swedish.
- Participants must be able to fill out the headache diary and questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Saline Injections for Prophylactic Treatment of Chronic Migraine - a Randomized Controlled Study
In this study, the investigators want to investigate whether saline injections in the neck and head muscles can reduce symptoms of chronic migraine. In existing studies, saline injections (used as placebo treatment) have given patients with chronic migraine an average of 7 headache-free days per month.
Read the detailed description
Patients who meet the diagnostic criteria for chronic migraine will be invited to participate in the study. All participants will undergo a medical examination. The participants will fill out an electronic headache diary for one month. This will give a picture of the current headache pattern and establish a baseline. The participants will then be randomized into two groups: saline injections or needle sticks without injection. They will not be aware of which group they belong to. The treatment will be repeated on two occasions three months apart. The headache diary will continue during the treatment period and up to three months after the second treatment. The effect will be analyzed by comparing baseline data from the headache diary to data after treatment. The primary outcome of the study is the number of days with headache, during a 28-day period.
- Conditions
- Chronic Migraine
- Being tested
- Saline injection, Placebo
- Keywords
- Chronic migraine, Saline injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline injectionDrug
Also called Sodium chloride Braun, Sodium chloride Fresenius Krabi
Half of the patients will be randomized to saline injections into the neck and head muscles
PlaceboProcedure or surgery
Half of the group will be treated with needle stings without injections
| Study group | Role | What they receive |
|---|---|---|
| Sodium chloride injection | Experimental | Sodium chloride 9mg/ml by injection Receives: Drug: Saline injection |
| Needle sting | Placebo comparator | Brief needle stings without injection Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of Days with headache
A headache day is defined as: 1) a day with headache ≥ 4 hours or 2) a day with headache of any duration, where the headache is relieved with acute headache medication (AHM)
By AHM is meant a drug that is taken when needed for the purpose of relieving headaches, including any of the following:
- Paracetamol
- Aspirin
- NSAID
- Triptan
- Opioid
- Ergotamine
- Dihydroergotamine
The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Measured: change between baseline 28 day period prior injection1 and 28 day period ending study
Change in number of Days with headache
A headache day is defined as: 1) a day with headache ≥ 4 hours or 2) a day with headache of any duration, where the headache is relieved with acute headache medication.
By AHM is meant a drug that is taken when needed for the purpose of relieving headaches, including any of the following:
- Paracetamol
- Aspirin
- NSAID
- Triptan
- Opioid
- Ergotamine
- Dihydroergotamine
The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Measured: change between baseline and the 28-day period preceding the second injection
Secondary outcomes (8)
Number of Days with moderate or severe headache
A headache day with moderate or severe intensity is defined as: 1) a day with headache ≥ 4 hours and with a peak of moderate or severe intensity or 2) a day with headache of any duration or intensity, where the headache is relieved with AHM. The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Measured: change between baseline 28 day period prior injection1 and 28 day period ending study
Number of Days with moderate or severe headache
A headache day with moderate or severe intensity is defined as: 1) a day with headache ≥ 4 hours and with a peak of moderate or severe intensity or 2) a day with headache of any duration or intensity, where the headache is relieved with AHM. The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Measured: change between baseline and the 28-day period preceding the second injection
Number of days with acute headache medication
Number of days the respondent stated that AHM has been taken.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Measured: change between baseline 28 day period prior injection1 and 28 day period ending study
Number of days with acute headache medication
Number of days the respondent stated that AHM has been taken.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Measured: change between baseline and the 28-day period preceding the second injection
Number of days with acute headache medication that requires prescription
Number of days the respondent stated that he or she has taken acute headache medication that require prescription, ie all drugs in the list in primary outcome above that require prescription by a doctor.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Measured: change between baseline 28 day period prior injection1 and 28 day period ending study
Number of days with acute headache medication that requires prescription
Number of days the respondent stated that he or she has taken acute headache medication that require prescription, ie all drugs in the list in primary outcome above that require prescription by a doctor.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Measured: change between baseline and the 28-day period preceding the second injection
Change in outcome of disease-specific quality of Life: Migraine-specific Quality of Life Questionnaire (MSQ v2.1)
Change in Migraine-specific Quality of Life Questionnaire (MSQ v2.1)
Measured: Change between baseline and 12 weeks after second injection
Change in outcome of disease-specific implications: Headache Impact Test (HIT-6)
Change in Headache Impact Test (HIT-6)
Measured: Change between baseline and 12 weeks after second injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start17 Jun 2019
- Primary completion21 May 2021
- Study completion21 May 2021
Why it stopped: Due to Covid-19 the rehabilitation unit where the trial was conducted were closed and the trial active clinician had to work at the hospital intensive care.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malin Kim, MD, Principal investigator, Rehabilitation clinic, Southern Älvsborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919045
- Sponsor's protocol ID
- Migraine1
- Other IDs
- 2018-003868-32, 2018
- Status last verified
- Mar 2022
- First submitted
- 8 Apr 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cole JC, Lin P, Rupnow MF. Validation of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v. 2.1) for patients undergoing prophylactic migraine treatment. Qual Life Res. 2007 Sep;16(7):1231-7. doi: 10.1007/s11136-007-9217-1. Epub 2007 Apr 28.
PubMed 17468941Dodick 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.
PubMed 20487038Freitag FG, Diamond S, Diamond M, Urban G. Botulinum Toxin Type A in the treatment of chronic migraine without medication overuse. Headache. 2008 Feb;48(2):201-9. doi: 10.1111/j.1526-4610.2007.00963.x. Epub 2007 Nov 28.
PubMed 18042229Gandek B, Alacoque J, Uzun V, Andrew-Hobbs M, Davis K. Translating the Short-Form Headache Impact Test (HIT-6) in 27 countries: methodological and conceptual issues. Qual Life Res. 2003 Dec;12(8):975-9. doi: 10.1023/a:1026171315263.
PubMed 14651416Smelt AF, Assendelft WJ, Terwee CB, Ferrari MD, Blom JW. What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primary-care population of migraine patients. Cephalalgia. 2014 Jan;34(1):29-36. doi: 10.1177/0333102413497599. Epub 2013 Jul 10.
PubMed 23843470Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. doi: 10.1111/j.1526-4610.2005.4501003.x.
PubMed 15833086Kim M, Danielsson A, Ekelund A-C, Kemppainen E, Sjögren P, Svanberg T, Szalo G,Samuelsson O. Title:Botulinum toxin type A for Prophylactic Treatment of Chronic Migraine [Botulinum toxin typ Asom profylaktisk behandling av kronisk migrän]. Göteborg: Västra Götalandsregionen, SahlgrenskaUniversitetssjukhuset, HTA-centrum; 2014. Regional activity-based HTA 2014:70
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Injections for Prophylactic Treatment of Chronic Migraine - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03919045
- Acronym / sponsor ID
- Migraine1
- Conditions
- Chronic Migraine
- Keywords
- Chronic migraine, Saline injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Covid-19 the rehabilitation unit where the trial was conducted were closed and the trial active clinician had to work at the hospital intensive care.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 18 Apr 2019 (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.
In this study, the investigators want to investigate whether saline injections in the neck and head muscles can reduce symptoms of chronic migraine. In existing studies, saline injections (used as placebo treatment) have given patients with chronic migraine an average of 7 headache-free days per month.
Detailed description
Patients who meet the diagnostic criteria for chronic migraine will be invited to participate in the study. All participants will undergo a medical examination. The participants will fill out an electronic headache diary for one month. This will give a picture of the current headache pattern and establish a baseline. The participants will then be randomized into two groups: saline injections or needle sticks without injection. They will not be aware of which group they belong to. The treatment will be repeated on two occasions three months apart. The headache diary will continue during the treatment period and up to three months after the second treatment. The effect will be analyzed by comparing baseline data from the headache diary to data after treatment. The primary outcome of the study is the number of days with headache, during a 28-day period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium chloride injection | Experimental | Drug: Saline injectionSodium chloride 9mg/ml by injection |
| Needle sting | Placebo comparator | Procedure: PlaceboBrief needle stings without injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must meet the diagnostic criteria for chronic migraine (headache that have occurred on at least 15 days per month, for at least three months. At least eight of the headache episodes must be typical for migraine).
- Participants must be able to understand and give informed consent to participate in the study.
- Participants must be aged 18-65 years.
Key exclusion criteria (12 listed)
- Participants must not suffer from other medical conditions that may affect the outcome of the study, including Horton's headache, temporal arteritis, trigeminal neuralgia, chronic paroxysmal hemi-crania, atypical facial pain and headache of unknown cause.
- Participants must not have medical conditions that require use of drugs that can affect the headache pattern (for example rheumatic disorders).
- Participants must not suffer from malignant diseases.
- Participants must not plan to make changes to existing prophylactic headache medication during the study. Patients may, if already on treatment, choose to continue this throughout the course of the study, or choose to stop the prophylactic treatment at least one week before the start of the baseline period.
- Participants must not have an ongoing patient-doctor contact with the physician giving the injections.
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 |
|---|---|---|
| Saline injectionAlso: Sodium chloride Braun, Sodium chloride Fresenius KrabiHalf of the patients will be randomized to saline injections into the neck and head muscles | Drug | Sodium chloride injection |
| PlaceboHalf of the group will be treated with needle stings without injections | Procedure or surgery | Needle sting |
Primary outcome
Change in number of Days with headache
Time frame: change between baseline 28 day period prior injection1 and 28 day period ending study
A headache day is defined as: 1) a day with headache ≥ 4 hours or 2) a day with headache of any duration, where the headache is relieved with acute headache medication (AHM) By AHM is meant a drug that is taken when needed for the purpose of relieving headaches, including any of the following: * Paracetamol * Aspirin * NSAID * Triptan * Opioid * Ergotamine * Dihydroergotamine The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Change in number of Days with headache
Time frame: change between baseline and the 28-day period preceding the second injection
A headache day is defined as: 1) a day with headache ≥ 4 hours or 2) a day with headache of any duration, where the headache is relieved with acute headache medication. By AHM is meant a drug that is taken when needed for the purpose of relieving headaches, including any of the following: * Paracetamol * Aspirin * NSAID * Triptan * Opioid * Ergotamine * Dihydroergotamine The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
8 secondary outcomes
Number of Days with moderate or severe headache
Time frame: change between baseline 28 day period prior injection1 and 28 day period ending study
Number of Days with moderate or severe headache
Time frame: change between baseline and the 28-day period preceding the second injection
Number of days with acute headache medication
Time frame: change between baseline 28 day period prior injection1 and 28 day period ending study
Number of days with acute headache medication
Time frame: change between baseline and the 28-day period preceding the second injection
Number of days with acute headache medication that requires prescription
Time frame: change between baseline 28 day period prior injection1 and 28 day period ending study
Number of days with acute headache medication that requires prescription
Time frame: change between baseline and the 28-day period preceding the second injection
Change in outcome of disease-specific quality of Life: Migraine-specific Quality of Life Questionnaire (MSQ v2.1)
Time frame: Change between baseline and 12 weeks after second injection
Change in outcome of disease-specific implications: Headache Impact Test (HIT-6)
Time frame: Change between baseline and 12 weeks after second injection
Results and safety
The study was stopped early (reason given: Due to Covid-19 the rehabilitation unit where the trial was conducted were closed and the trial active clinician had to work at the hospital intensive care.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 17468941Cole JC, Lin P, Rupnow MF. Validation of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v. 2.1) for patients undergoing prophylactic migraine treatment. Qual Life Res. 2007 Sep;16(7):1231-7. doi: 10.1007/s11136-007-9217-1. Epub 2007 Apr 28.
- Background: PubMed 20487038Dodick 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.
- Background: PubMed 18042229Freitag FG, Diamond S, Diamond M, Urban G. Botulinum Toxin Type A in the treatment of chronic migraine without medication overuse. Headache. 2008 Feb;48(2):201-9. doi: 10.1111/j.1526-4610.2007.00963.x. Epub 2007 Nov 28.
- Background: PubMed 14651416Gandek B, Alacoque J, Uzun V, Andrew-Hobbs M, Davis K. Translating the Short-Form Headache Impact Test (HIT-6) in 27 countries: methodological and conceptual issues. Qual Life Res. 2003 Dec;12(8):975-9. doi: 10.1023/a:1026171315263.
- Background: PubMed 23843470Smelt AF, Assendelft WJ, Terwee CB, Ferrari MD, Blom JW. What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primary-care population of migraine patients. Cephalalgia. 2014 Jan;34(1):29-36. doi: 10.1177/0333102413497599. Epub 2013 Jul 10.
- Background: PubMed 15833086Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. doi: 10.1111/j.1526-4610.2005.4501003.x.
- BackgroundKim M, Danielsson A, Ekelund A-C, Kemppainen E, Sjögren P, Svanberg T, Szalo G,Samuelsson O. Title:Botulinum toxin type A for Prophylactic Treatment of Chronic Migraine [Botulinum toxin typ Asom profylaktisk behandling av kronisk migrän]. Göteborg: Västra Götalandsregionen, SahlgrenskaUniversitetssjukhuset, HTA-centrum; 2014. Regional activity-based HTA 2014:70
- Individual participant dataSharing planned: No
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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.
Malin Kim, MD principal investigator
Rehabilitation clinic, Southern Älvsborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline injection in people with Chronic Migraine, run by Göteborg University at 1 site in Sweden.
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 12 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: stopped early, as of the sponsor's last update on 31 Mar 2022. 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 Sweden. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 stopped early (reason given: Due to Covid-19 the rehabilitation unit where the trial was conducted were closed and the trial active clinician had to work at the hospital intensive care.). Results are not available in the source record.
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 in number of Days with headache (time frame: change between baseline 28 day period prior injection1 and 28 day period ending study). 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 NCT03919045, which also lists 7 linked publications.
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 31 Mar 2022.