NCT03381261CompletedPhase 4
(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
Novel Concepts for OnabotulinumtoxinA (Botox) Mechanisms of Action: Role in Altering the Molecular Environment in Which Pain Fibers Exist
Source: ClinicalTrials.gov · Last updated 24 Mar 2025
Brief summary (registry, in English)
To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 18 Dec 2017
- Start date
- 1 Dec 2017
- Primary completion date
- 1 Aug 2023
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Migraine
- NCT number
- NCT03381261
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 37
- From 1 Dec 2017 to the primary completion date, 1 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient has hypersensitivity reactions or other intolerance to Botox
- Infection at proposed injection sites.
Other
- Patient is pregnant or trying to become pregnant with the timeframe of the study.
Who the study is looking for
- Age 18-65 years
- Diagnosis of Chronic Migraine consistent with International Classification of Headache Disorders (ICHD-III) criteria, with a history of bilateral headache pain and chronic tenderness in neck muscles
- Patient is capable and willing to provide informed consent
- Female subjects of child bearing potential must have a negative pregnancy test at enrollment and agree to remain abstinent or use acceptable methods of birth control (i.e., hormonal contraceptives, inrauterine device, diaphragm with spermicide, cervical cap or sponge, condoms or partner has had a vasectomy) for three months following injections of Botox
- Patients referred by their primary Neurologist to the study surgeon and who are determined to be candidates for surgical decompression of extracranial sensory nerves.
- Patient agrees to abstain from protocol-specific excluded medications beginning 14 days prior to the decompression surgery.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.