A study to investigate the effectiveness of performing a nerve block on patients suffering from chronic migraines.

• Register: EUCTR
• Last refreshed on: 20 April 2020
• Main ID: EUCTR2014-001115-39-GB
• Date of registration: 11/09/2015
• Prospective Registration: Yes
• Primary sponsor: Barts Health NHS Trust
• Public title: A study to investigate the effectiveness of performing a nerve block on patients suffering from chronic migraines.
• Scientific title: A phase IV single-blind placebo-controlled cross-over study to investigate the efficacy of greater occipital nerve block with local anaesthetic and steroid in patients with chronic migraine. - GON migraine study
• Date of first enrolment: 29/12/2015
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001115-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Sally Burtles
• Affiliation: Barts Health NHS Trust

• Name: Sally Burtles
• Affiliation: Barts Health NHS Trust

Key inclusion & exclusion criteria

Inclusion criteria:
1.Age over 18 and ability to provide written consent.
2.Diagnosis of chronic migraine with or without acute relief medication overuse (ICHD-II codes 1.5.1 and 1.6.5); as confirmed by diary documentation (headache on 15 or more days a month for at least 3 months).
3.Ability to read and write English (questionnaire use in the study)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
1.Patient refusal.
2.Participation in another trial of any investigational products or interventional research project within the previous 8 weeks.
3.Patients unable to commit to the 6-month study duration.
4.Patients with known hypersensitivity to the investigational medicinal products used in the study.
5.Patients with a history of substance abuse.
6.Pregnant or breastfeeding patients.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic migraine
MedDRA version: 18.0 Level: LLT Classification code 10066636 Term: Chronic migraine System Organ Class: 100000004852

Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Intervention(s)

Trade Name: Lidocaine 2%
Product Name: 2% Lidocaine
Product Code: N/A
Pharmaceutical Form: Injection
INN or Proposed INN: Lidocaine
CAS Number: 137-58-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Subcutaneous use

Trade Name: Depo-Medrone
Product Name: Methylprednisolone
Product Code: 18157/0227
Pharmaceutical Form: Injection
INN or Proposed INN: Methylprednisolone
CAS Number: 83432
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline
4 weeks post treatment
8 weeks post treatment
12 weeks post treatment
* every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).

Cross over
4 weeks post treatment
8 weeks post treatment
12 weeks post treatment
* every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).

Main Objective: The primary objective of this study, is to investigate any change in disability associated with chronic migraine disorder in the two treatment arms (greater occipital nerve block versus placebo procedure).

Primary end point(s): The primary outcome being measured in this study is improvement in disability associated with chronic migraine disorder as assessed by:
• Change in the Headache Impact Test (HIT-6) questionnaire score
• Change in the Migraine-Specific Questionnaire (MSQ) score
• Change in the 12-item Short Form Health Survey (SF-12) questionnaire score

Secondary Objective: a. To assess change in participant headache frequency and severity,
b. To assess the change in participant anxiety and depression levels,
c. To assess the safety and tolerability in the two treatment arms.
d. To assess the eligibility criteria, recruitment and retention of participants in the two treatment arms.
e. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams.

Secondary Outcome(s)

Secondary end point(s): The secondary objectives are to assess:
a. change in headache characteristics: frequency & severity (HIT-6 score)
b. change in anxiety and depression (HAD scores)
c. safety of intervention (SAR/SAE reports)
d. tolerability (SAR/SAE reports)
e. economic outcomes
f. eligibility criteria, recruitment and retention of patients in the two treatment arms (recruitment and retention rates).
g. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams (questionnaire upon completion of study and feedback from clinicians regarding overall feasibility/acceptability of the two treatment arms).

Timepoint(s) of evaluation of this end point: Baseline
4 weeks post treatment
8 weeks post treatment
12 weeks post treatment
* every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).
Cross over
4 weeks post treatment
8 weeks post treatment
12 weeks post treatment
* every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).

Secondary ID(s)

GON2014/05

Source(s) of Monetary Support

Pain & Anaesthesia Research Centre

Ethics review

Status: Approved
Approval date: 29/12/2015
Contact: