Saline Injections for Prophylactic Treatment of Chronic Migraine

NCT03919045 | Terminated Phase 4

• 2 other identifiers: Migraine12018-003868-32
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine

Keywords

Chronic migraine; Saline injection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  change between baseline and the 28-day period preceding the second injection

Secondary Outcomes (8)

• Number of Days with moderate or severe headache

  change between baseline 28 day period prior injection1 and 28 day period ending study

• Number of Days with moderate or severe headache

  change between baseline and the 28-day period preceding the second injection

• Number of days with acute headache medication

  change between baseline 28 day period prior injection1 and 28 day period ending study

• Number of days with acute headache medication

  change between baseline and the 28-day period preceding the second injection

• Number of days with acute headache medication that requires prescription

  change between baseline 28 day period prior injection1 and 28 day period ending study

Study Arms (2)

Sodium chloride injection

EXPERIMENTAL

Sodium chloride 9mg/ml by injection

Drug: Saline injection

Needle sting

PLACEBO COMPARATOR

Brief needle stings without injection

Procedure: Placebo

Interventions

Saline injection DRUG

Half of the patients will be randomized to saline injections into the neck and head muscles

Also known as: Sodium chloride Braun, Sodium chloride Fresenius Krabi

Sodium chloride injection

Placebo PROCEDURE

Half of the group will be treated with needle stings without injections

Needle sting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Rehabilitation clinic, Southern Älvsborg Hospital

Borås, Sweden

Location

Related Publications (7)

• 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.

  PMID: 17468941 BACKGROUND

• Dodick 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.

  PMID: 20487038 BACKGROUND

• Freitag 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.

  PMID: 18042229 BACKGROUND

• Gandek 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.

  PMID: 14651416 BACKGROUND

• Smelt 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.

  PMID: 23843470 BACKGROUND

• Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. doi: 10.1111/j.1526-4610.2005.4501003.x.

  PMID: 15833086 BACKGROUND

• Kim 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

  BACKGROUND

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Malin Kim, MD

  Rehabilitation clinic, Southern Älvsborg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: No Outcome assessor present in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 18, 2019
• Study Start: June 17, 2019
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)