Sphenopalatine BlockNCT06974617
Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine
A study testing Sphenopalatine block and Botulinum Toxin Type A in people with Sphenopalatine Block and BOTOX, run by Cairo University at 1 site in Egypt.
Trial summary
This trial compares the efficacy and safety of sphenopalatine ganglion block (SPGB) and intramuscular BOTOX injection in chronic migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sphenopalatine Block, BOTOX, Chronic Migraine
- What is being tested?
- Sphenopalatine block and Botulinum Toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and 65 years.
- Both sexes.
- Chronic migraine. Chronic migraine, defined as headaches on ≥15 days per month for ≥3 months, of which ≥8 days meet criteria for migraine without aura or respond to migraine-specific treatment according to International Classification of Headache Disorders-3 Beta.
Who cannot join
- Patients with medication over use headache.
- Bleeding disorders.
- Abnormal neurological examination.
- History of allergy to local anesthetics or BOTOX.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Mohamed E Abdel Fattah, MD, 00201284475792, mohamed-elsaid@cu.edu.eg
Samuel F Samy, MD
About this study
Official title: Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine: A Randomized Clinical Trial
This trial compares the efficacy and safety of sphenopalatine ganglion block (SPGB) and intramuscular BOTOX injection in chronic migraine.
Read the detailed description
The International Headache Society's Headache Classification Committee recognizes three broad categories of headaches: primary headaches, secondary headaches, and a third catchall category called "painful cranial neuropathies, other facial pain, and other headaches." Migraines fall into the primary headache category.
Sphenopalatine ganglion (SPG), or the pterygopalatine ganglion (PPG), is a large extracranial parasympathetic ganglion with multiple neural connections, including autonomic and motor.
The botulinum toxin (BOTOX®), which can exert a paralytic effect by binding to presynaptic cholinergic nerve terminals at the neuromuscular junction, is produced by the Gram-positive, rod-shaped, spore-forming, anaerobic bacterium Clostridium botulinum. It internalizes and inhibits the exocytosis of the neurotransmitter acetylcholine by decreasing the frequency of acetylcholine release
- Conditions
- Sphenopalatine Block, BOTOX, Chronic Migraine
- Being tested
- Sphenopalatine block, Botulinum Toxin Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine blockDrug
Also called Lidocaine
Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril.
Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.
| Study group | Role | What they receive |
|---|---|---|
| Sphenopalatine block group | Experimental | Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril. Receives: Drug: Sphenopalatine block |
| BOTOX group | Experimental | Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm. Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
The patients will be shown how to use the Visual Analogue Scale (VAS); 0-10 point where 0 = no pain and 10 = worst imaginable pain. VAS will be noted as well as after procedure, four-week, and 12-weeks period.
Measured: 12 weeks post-procedure
Secondary outcomes (2)
Percentage of patients free of headache
The percentage of patients free of headache at baseline (just before the procedure), after procedure, four-week, and 12-weeks period.
Measured: 12 weeks post-procedure
Headache relief rate
Headache relief rate (percentage of patients with 50% or more reduction in headache intensity at four-week and 12-weeks period).
Measured: 12 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 May 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sphenopalatine BlockStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsaid Abdel Fattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974617
- Sponsor's protocol ID
- AP2411-501-101-193
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06974617
- Acronym / sponsor ID
- AP2411-501-101-193
- Conditions
- Sphenopalatine Block, BOTOX, Chronic Migraine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 16 May 2025 (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.
This trial compares the efficacy and safety of sphenopalatine ganglion block (SPGB) and intramuscular BOTOX injection in chronic migraine.
Detailed description
The International Headache Society's Headache Classification Committee recognizes three broad categories of headaches: primary headaches, secondary headaches, and a third catchall category called "painful cranial neuropathies, other facial pain, and other headaches." Migraines fall into the primary headache category.
Sphenopalatine ganglion (SPG), or the pterygopalatine ganglion (PPG), is a large extracranial parasympathetic ganglion with multiple neural connections, including autonomic and motor.
The botulinum toxin (BOTOX®), which can exert a paralytic effect by binding to presynaptic cholinergic nerve terminals at the neuromuscular junction, is produced by the Gram-positive, rod-shaped, spore-forming, anaerobic bacterium Clostridium botulinum. It internalizes and inhibits the exocytosis of the neurotransmitter acetylcholine by decreasing the frequency of acetylcholine release
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sphenopalatine block group | Experimental | Drug: Sphenopalatine blockPatients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril. |
| BOTOX group | Experimental | Drug: Botulinum Toxin Type APatients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and 65 years.
- Both sexes.
- Chronic migraine. Chronic migraine, defined as headaches on ≥15 days per month for ≥3 months, of which ≥8 days meet criteria for migraine without aura or respond to migraine-specific treatment according to International Classification of Headache Disorders-3 Beta.
Key exclusion criteria (4 listed)
- Patients with medication over use headache.
- Bleeding disorders.
- Abnormal neurological examination.
- History of allergy to local anesthetics or BOTOX.
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 |
|---|---|---|
| Sphenopalatine blockAlso: LidocainePatients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril. | Drug | Sphenopalatine block group |
| Botulinum Toxin Type APatients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm. | Drug | BOTOX group |
Primary outcome
Degree of pain
Time frame: 12 weeks post-procedure
The patients will be shown how to use the Visual Analogue Scale (VAS); 0-10 point where 0 = no pain and 10 = worst imaginable pain. VAS will be noted as well as after procedure, four-week, and 12-weeks period.
2 secondary outcomes
Percentage of patients free of headache
Time frame: 12 weeks post-procedure
Headache relief rate
Time frame: 12 weeks post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Sphenopalatine Block
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Not yet recruiting
Sphenopalatine Ganglion Block Combined With Either Scalp Nerve Block or Local Wound Infiltration for Postoperative Analgesia in Adult Patients Undergoing Craniotomy: A Randomized Controlled Trial
Craniotomy Surgery
Not yet recruitingPhase 4
Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy
Postoperative Pain, Tonsillectomy
RecruitingPhase 2/3
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
SAH (Subarachnoid Hemorrhage), Headache
Not yet recruitingPhase 2
Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine
Migraine, Facial Pain or Pressure
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine block and Botulinum Toxin Type A in people with Sphenopalatine Block and BOTOX, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Abdel Fattah, MD (00201284475792, mohamed-elsaid@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 12 weeks post-procedure). 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 16 May 2025.