MigraineNCT04750967
Amitriptyline vs GON and SON Blocks in Migraine
A study testing Lidocaine 1% Injectable Solution and Amitriptyline in people with Migraine and Headache, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of efficacy and safety of amitriptyline and nerve blocks Read more about this study
- Who is it for?
- Ages 18 to 50 years
- What is being tested?
- Lidocaine 1% Injectable Solution and Amitriptyline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2021to 15 Jul 2023
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with migraine according to ICHD-3
Who cannot join
- Being over 50 years or under 18 years
- Malignancy and other systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Amitriptyline and Nerve Blocks (GON and SON) in Patients With Migraine
Comparison of efficacy and safety of amitriptyline and nerve blocks
Read the detailed description
This study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater occipital nerve and supraorbital nerve)
- Being tested
- Lidocaine 1% Injectable Solution, Amitriptyline
- Keywords
- greater occipital nerve, supraorbital nerve, nerve blocks
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1% Injectable SolutionDrug
Repeated injections of lidocaine to greater occipital nerve and supraorbital nerve once a week for first four weeks then once a month for five months
AmitriptylineDrug
Amitriptyline 25 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Greater occipital nerve and supraorbital nerve block with 1% lidocaine once a week for first four weeks then once a month for 5 months Receives: Drug: Lidocaine 1% Injectable Solution |
| Control | Active comparator | Amitriptyline 25 mg daily for 6 months Receives: Drug: Amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with 50% Reduction of Headache Frequency
Monthly headache frequency will be followed
Measured: 6 months
Secondary outcomes (1)
Side effects
Major and minor side effects will be followed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start3 Apr 2021
- Primary completion1 Jan 2022
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cem Bölük, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750967
- Sponsor's protocol ID
- E-70847213-929-3410
- Status last verified
- Sep 2023
- First submitted
- 8 Feb 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Amitriptyline and Nerve Blocks (GON and SON) in Patients With Migraine
- ClinicalTrials.gov ID
- NCT04750967
- Acronym / sponsor ID
- E-70847213-929-3410
- Keywords
- greater occipital nerve, supraorbital nerve, nerve blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 11 Feb 2021 (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.
Comparison of efficacy and safety of amitriptyline and nerve blocks
Detailed description
This study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater occipital nerve and supraorbital nerve)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Lidocaine 1% Injectable SolutionGreater occipital nerve and supraorbital nerve block with 1% lidocaine once a week for first four weeks then once a month for 5 months |
| Control | Active comparator | Drug: AmitriptylineAmitriptyline 25 mg daily for 6 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosed with migraine according to ICHD-3
Key exclusion criteria (2 listed)
- Being over 50 years or under 18 years
- Malignancy and other systemic diseases
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 |
|---|---|---|
| Lidocaine 1% Injectable SolutionRepeated injections of lidocaine to greater occipital nerve and supraorbital nerve once a week for first four weeks then once a month for five months | Drug | Active |
| AmitriptylineAmitriptyline 25 mg daily | Drug | Control |
Primary outcome
Number of Participants with 50% Reduction of Headache Frequency
Time frame: 6 months
Monthly headache frequency will be followed
1 secondary outcome
Side effects
Time frame: 6 months
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 8 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 1% Injectable Solution and Amitriptyline in people with Migraine and Headache, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 8 Sep 2023. 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 Turkey (Türkiye). 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.
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 Participants with 50% Reduction of Headache Frequency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.