Oromandibular DystoniaPhase 1OMD _ BTX-ANCT07792798
Botulinum Toxin A for Jaw Dystonia .
A Phase 1 study testing Botulinum Toxin Type A (BOTOX) Injection in people with Oromandibular Dystonia and Electromyography, run by Sana'a University at 1 site in Yemen.
Trial summary
This study evaluates the effectiveness and safety of Electromyography (EMG)-guided Botulinum Toxin type A (BTX-A) injections in treating oromandibular dystonia (OMD) among a sample of Yemeni patients. Read more about this study
- Who is it for?
- Ages 31 to 60 years
- Conditions the study is for
- Oromandibular Dystonia, Electromyography
- What is being tested?
- Botulinum Toxin Type A (BOTOX) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteYemen
- Study dates
- 13 Sep 2022to 17 Oct 2024
- Phase
- Phase 1
- 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 31 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a confirmed diagnosis of OMD based on clinical evaluation. ii) Patients who have been referred to the maxillofacial departments at the Faculty of Dentistry, Sana'a University, specifically for the treatment of OMD.
- Commitment to follow-up visits
Who cannot join
- The presence of pathological findings at the site of injection, such as fibrous dysplasia, tumors, or cysts.
- Patients who have known contraindications or allergies to botulinum toxin or its components.
- Patients who are unlikely to be available for the required follow-up visits or have limited accessibility to the study site.
- Previously treated with BTX-A within 6 months. v) Pregnant woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Botulinum Toxin A in the Treatment of Oromandibular Dystonia in a Sample of Yemeni Patients
This study evaluates the effectiveness and safety of Electromyography (EMG)-guided Botulinum Toxin type A (BTX-A) injections in treating oromandibular dystonia (OMD) among a sample of Yemeni patients. Oromandibular dystonia is a neurological movement disorder characterized by involuntary contractions of the jaw, tongue, and face muscles, which severely interferes with essential daily functions such as chewing, speaking, and swallowing.
A prospective clinical trial was conducted on 20 patients diagnosed with different clinical subtypes of OMD (jaw closing, jaw opening, and jaw deviation). Targeted muscles were injected with BTX-A using EMG guidance to ensure precise placement. Patients were evaluated over a 6-month follow-up period to measure improvements in mastication ability, speech, and functional discomfort, as well as to document any adverse side effects.
- Conditions
- Oromandibular Dystonia, Electromyography
- Being tested
- Botulinum Toxin Type A (BOTOX) Injection
- Keywords
- oromandibular dystonia, electromyography, botulinum toxin.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A (BOTOX) InjectionDrug
Electromyography (EMG)-guided intramuscular injections into specific affected masticatory and lower facial muscles. Dosing is tailored to the specific oromandibular dystonia subtype (e.g., jaw closing, jaw opening, or mixed) and targeted muscles (such as the Masseter, Temporal, Medial Pterygoid, Lateral Pterygoid, or Digastric muscles). The injections are administered using an EMG device (e.g., Dantec Clavis) to ensure precise localization of the hyperactive muscles prior to injection.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A . | Experimental | Not described Receives: Drug: Botulinum Toxin Type A (BOTOX) Injection |
| Electromyography guided botulinum toxin _A Injection Group . | Experimental | Not described Receives: Drug: Botulinum Toxin Type A (BOTOX) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oromandibular Dystonia Symptoms Following EMG-Guided Botulinum Toxin Type A Injection
The primary outcome was the change in the severity of the main symptoms of oromandibular dystonia following electromyography-guided botulinum toxin type A (BTX-A) injection. The symptoms assessed were mastication ability, discomfort, speech, and pain. Each symptom was evaluated using a 5-point ordinal rating scale ranging from 0 (normal/no symptoms) to 4 (severe impairment). Changes from baseline were assessed during follow-up visits at 1 week, 3 months, and 6 months after BTX-A injection.
Measured: Baseline (immediately before BTX-A injection), 1 week, 3 months, and 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start13 Sep 2022
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oromandibular DystoniaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naif Rasheed abdulrab Alareqi, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792798
- Sponsor's protocol ID
- OMFS:07/09/2024
- Acronym
- OMD _ BTX-A
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Botulinum Toxin A in the Treatment of Oromandibular Dystonia in a Sample of Yemeni Patients
- ClinicalTrials.gov ID
- NCT07792798
- Acronym / sponsor ID
- OMD _ BTX-A / OMFS:07/09/2024
- Conditions
- Oromandibular Dystonia, Electromyography
- Keywords
- oromandibular dystonia, electromyography, botulinum toxin.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 28 Aug 2026 (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 study evaluates the effectiveness and safety of Electromyography (EMG)-guided Botulinum Toxin type A (BTX-A) injections in treating oromandibular dystonia (OMD) among a sample of Yemeni patients. Oromandibular dystonia is a neurological movement disorder characterized by involuntary contractions of the jaw, tongue, and face muscles, which severely interferes with essential daily functions such as chewing, speaking, and swallowing.
A prospective clinical trial was conducted on 20 patients diagnosed with different clinical subtypes of OMD (jaw closing, jaw opening, and jaw deviation). Targeted muscles were injected with BTX-A using EMG guidance to ensure precise placement. Patients were evaluated over a 6-month follow-up period to measure improvements in mastication ability, speech, and functional discomfort, as well as to document any adverse side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A . | Experimental | Drug: Botulinum Toxin Type A (BOTOX) Injection |
| Electromyography guided botulinum toxin _A Injection Group . | Experimental | Drug: Botulinum Toxin Type A (BOTOX) Injection |
Who may qualify
- Ages
- 31 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with a confirmed diagnosis of OMD based on clinical evaluation. ii) Patients who have been referred to the maxillofacial departments at the Faculty of Dentistry, Sana'a University, specifically for the treatment of OMD.
- Commitment to follow-up visits
Key exclusion criteria (4 listed)
- The presence of pathological findings at the site of injection, such as fibrous dysplasia, tumors, or cysts.
- Patients who have known contraindications or allergies to botulinum toxin or its components.
- Patients who are unlikely to be available for the required follow-up visits or have limited accessibility to the study site.
- Previously treated with BTX-A within 6 months. v) Pregnant woman.
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 |
|---|---|---|
| Botulinum Toxin Type A (BOTOX) InjectionElectromyography (EMG)-guided intramuscular injections into specific affected masticatory and lower facial muscles. Dosing is tailored to the specific oromandibular dystonia subtype (e.g., jaw closing, jaw opening, or mixed) and targeted muscles (such as the Masseter, Temporal, Medial Pterygoid, Lateral Pterygoid, or Digastric muscles). The injections are administered using an EMG device (e.g., Dantec Clavis) to ensure precise localization of the hyperactive muscles prior to injection. | Drug | Botulinum Toxin Type A ., Electromyography guided botulinum toxin _A Injection Group . |
Primary outcome
Change in Oromandibular Dystonia Symptoms Following EMG-Guided Botulinum Toxin Type A Injection
Time frame: Baseline (immediately before BTX-A injection), 1 week, 3 months, and 6 months after injection
The primary outcome was the change in the severity of the main symptoms of oromandibular dystonia following electromyography-guided botulinum toxin type A (BTX-A) injection. The symptoms assessed were mastication ability, discomfort, speech, and pain. Each symptom was evaluated using a 5-point ordinal rating scale ranging from 0 (normal/no symptoms) to 4 (severe impairment). Changes from baseline were assessed during follow-up visits at 1 week, 3 months, and 6 months after BTX-A injection.
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 28 Aug 2026.
Related trials for Oromandibular Dystonia
RecruitingObservational study
Brain Networks in Dystonia
Spasmodic Dysphonia, Singer's Dystonia
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 Phase 1 study testing Botulinum Toxin Type A (BOTOX) Injection in people with Oromandibular Dystonia and Electromyography, run by Sana'a University at 1 site in Yemen.
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 2 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: finished, as of the sponsor's last update on 28 Aug 2026. 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 Yemen. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Oromandibular Dystonia Symptoms Following EMG-Guided Botulinum Toxin Type A Injection (time frame: Baseline (immediately before BTX-A injection), 1 week, 3 months, and 6 months after injection). 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 28 Aug 2026.