Bell PalsyPhase 1/2NCT05821075
Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy
A Phase 1/2 study testing Prednisolone and Cerebrolysin in people with Bell Palsy, run by October 6 University at 1 site in Egypt.
Trial summary
Bell's palsy, a peripheral facial nerve paresis, is the most common disorder of the facial nerve and one of the most common mononeuropathies. Many patients with Bell's palsy will develop some complications such as synkinesis, crocodile tears and 'sweating' of the ear while eating Commonly used medications to treat… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Prednisolone and Cerebrolysin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Aug 2023to Feb 2026
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- unilateral acute facial palsy of no identifiable cause
Who cannot join
- Recurrent facial Bell's palsy
- Pregnancy
- Diabetes
- Epilepsy
- Severe hypertension,
- Renal or hepatic disease,
Show all 11Show fewer
- Gastric or duodenal ulcer
- presence of acute otitis media or ipsilateral chronic otitis
- Recent head injury,
- psychiatric disease
- If there is any contraindications for corticosteroids
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
October 6 university hospital
Giza, 12573
Abdelmaksod Mohammed Mousa, MD
About this study
Official title: Comparative Study Between Prednisolone, Cerebrolysin in the Treatment of Bell's Palsy
Bell's palsy, a peripheral facial nerve paresis, is the most common disorder of the facial nerve and one of the most common mononeuropathies.
Many patients with Bell's palsy will develop some complications such as synkinesis, crocodile tears and 'sweating' of the ear while eating Commonly used medications to treat Bell's palsy is Corticosteroids Cerebrolysin stimulates the regeneration of the nervous tissue with protective action we aim to study the efficacy of cerebrolycin in Bell's palsy
- Conditions
- Bell Palsy
- Being tested
- Prednisolone, Cerebrolysin
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
prednisolone 60mg tablet once daily for 5 days then tapering dose
CerebrolysinDrug
intramuscular Cerebrolysin 10 mg daily for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Active comparator | Not described Receives: Drug: Prednisolone |
| Cerebrolysin | Active comparator | Not described Receives: Drug: Cerebrolysin |
| Prednisolone and Cerebrolysin | Active comparator | Not described Receives: Drug: Prednisolone; Drug: Cerebrolysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in scores of the house Brackman grading system HB
Measured: at baseline, after 1 week, after 3 week
changes in scores of the Sunnybrook grading system.
Measured: at baseline, after 1 week, after 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start24 Aug 2023
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, engy wahsh, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821075
- Sponsor's protocol ID
- PRC-Ph-2211038
- Status last verified
- Jul 2025
- First submitted
- 7 Apr 2023
- Last updated
- 31 Jul 2025
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Prednisolone, Cerebrolysin in the Treatment of Bell's Palsy
- ClinicalTrials.gov ID
- NCT05821075
- Acronym / sponsor ID
- PRC-Ph-2211038
- Conditions
- Bell Palsy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Apr 2023 (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.
Bell's palsy, a peripheral facial nerve paresis, is the most common disorder of the facial nerve and one of the most common mononeuropathies.
Many patients with Bell's palsy will develop some complications such as synkinesis, crocodile tears and 'sweating' of the ear while eating Commonly used medications to treat Bell's palsy is Corticosteroids Cerebrolysin stimulates the regeneration of the nervous tissue with protective action we aim to study the efficacy of cerebrolycin in Bell's palsy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Active comparator | Drug: Prednisolone |
| Cerebrolysin | Active comparator | Drug: Cerebrolysin |
| Prednisolone and Cerebrolysin | Active comparator | Drug: Prednisolone, Drug: Cerebrolysin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- unilateral acute facial palsy of no identifiable cause
Key exclusion criteria (11 listed)
- Recurrent facial Bell's palsy
- Pregnancy
- Diabetes
- Epilepsy
- Severe hypertension,
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 |
|---|---|---|
| Prednisoloneprednisolone 60mg tablet once daily for 5 days then tapering dose | Drug | Prednisolone, Prednisolone and Cerebrolysin |
| Cerebrolysinintramuscular Cerebrolysin 10 mg daily for 3 weeks | Drug | Cerebrolysin, Prednisolone and Cerebrolysin |
Primary outcome
change in scores of the house Brackman grading system HB
Time frame: at baseline, after 1 week, after 3 week
changes in scores of the Sunnybrook grading system.
Time frame: at baseline, after 1 week, after 3 week
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 31 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Prednisolone and Cerebrolysin in people with Bell Palsy, run by October 6 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 1 inclusion and 11 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 31 Jul 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Engy Wahsh (01003095692, engywahsh@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in scores of the house Brackman grading system HB (time frame: at baseline, after 1 week, after 3 week). The study lists 2 primary outcomes in all. 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 31 Jul 2025.