Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Saline Injections for Prophylactic Treatment of Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03919045
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: Saline injection Procedure: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: No Outcome assessor present in the study.
Primary Purpose: Treatment
Official Title: Saline Injections for Prophylactic Treatment of Chronic Migraine - a Randomized Controlled Study
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Sodium chloride injection
Sodium chloride 9mg/ml by injection
Drug: Saline injection
Half of the patients will be randomized to saline injections into the neck and head muscles
Other Names:
  • Sodium chloride Braun
  • Sodium chloride Fresenius Krabi

Placebo Comparator: Needle sting
Brief needle stings without injection
Procedure: Placebo
Half of the group will be treated with needle stings without injections




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. Number of Days with moderate or severe headache [ Time Frame: change between baseline 28 day period prior injection1 and 28 day period ending study ]
    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.

  2. Number of Days with moderate or severe headache [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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.

  3. 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 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.

  4. Number of days with acute headache medication [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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.

  5. 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 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.

  6. Number of days with acute headache medication that requires prescription [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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.

  7. 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 Migraine-specific Quality of Life Questionnaire (MSQ v2.1)

  8. Change in outcome of disease-specific implications: Headache Impact Test (HIT-6) [ Time Frame: Change between baseline and 12 weeks after second injection ]
    Change in Headache Impact Test (HIT-6)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919045


Contacts
Layout table for location contacts
Contact: Anna Grimby Ekman, Assoc Prof +4676 618 31 23 anna.ekman@gu.se
Contact: Malin Kim, MD +4633281645 malin.kim@vgregion.se

Locations
Layout table for location information
Sweden
Rehabilitation clinic, Southern Älvsborg Hospital Not yet recruiting
Borås, Sweden
Contact: Malin Kim, MD         
Principal Investigator: Malin Kim, MD         
Sponsors and Collaborators
Göteborg University
Investigators
Layout table for investigator information
Principal Investigator: Malin Kim, MD Rehabilitation clinic, Southern Älvsborg Hospital

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03919045     History of Changes
Other Study ID Numbers: Migraine1
2018-003868-32 ( EudraCT Number )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Göteborg University:
Chronic migraine
Saline injection

Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases