Essential BlepharospasmPhase 3NCT03216473
Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm
A Phase 3 study testing Neuronox and Botox in people with Essential Blepharospasm, run by Medy-Tox.
Trial summary
This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with essential blepharospasm. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Blepharospasm
- What is being tested?
- Neuronox and Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2016to 4 Jul 2017
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75
- Subjects had to have a confirmed clinical diagnosis of essential blepharospasm requiring treatment by injection
Who cannot join
- Subjects who underwent surgical operation
- Subjects with Neuroleptic induced blepharospasm
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of NEURONOX® vs. BOTOX® in Patients With Essential Blepharospasm
This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with essential blepharospasm.
Read the detailed description
Subjects are randomly assigned into the two groups at the ratio of 1:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects with essential blepharospasm.
- Conditions
- Essential Blepharospasm
- Being tested
- Neuronox, Botox
- Medical subject headings
- Benign essential blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuronoxDrug
Also called Botulinum Toxin Type A for injection
Clostridium Botulinum Toxin A 100 U
BotoxDrug
Also called Botulinum Toxin Type A for injection
Clostridium Botulinum Toxin A 100 U
| Study group | Role | What they receive |
|---|---|---|
| Neuronox | Experimental | Botulinum Toxin Type A for injection Receives: Drug: Neuronox |
| Botox | Active comparator | Botulinum Toxin Type A for injection Receives: Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
JRS (Jankovic Rating Scale) sum-score
Change from baseline at 4 week for the JRS (Jankovic Rating Scale) sum-score
Measured: From baseline at 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start25 May 2016
- Primary completion17 Mar 2017
- Study completion4 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential BlepharospasmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216473
- Sponsor's protocol ID
- TG1221MED
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of NEURONOX® vs. BOTOX® in Patients With Essential Blepharospasm
- ClinicalTrials.gov ID
- NCT03216473
- Acronym / sponsor ID
- TG1221MED
- Conditions
- Essential Blepharospasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 25 May 2016 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 13 Jul 2017 (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 clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with essential blepharospasm.
Detailed description
Subjects are randomly assigned into the two groups at the ratio of 1:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects with essential blepharospasm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuronox | Experimental | Drug: NeuronoxBotulinum Toxin Type A for injection |
| Botox | Active comparator | Drug: BotoxBotulinum Toxin Type A for injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 to 75
- Subjects had to have a confirmed clinical diagnosis of essential blepharospasm requiring treatment by injection
Key exclusion criteria (2 listed)
- Subjects who underwent surgical operation
- Subjects with Neuroleptic induced blepharospasm
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 |
|---|---|---|
| NeuronoxAlso: Botulinum Toxin Type A for injectionClostridium Botulinum Toxin A 100 U | Drug | Neuronox |
| BotoxAlso: Botulinum Toxin Type A for injectionClostridium Botulinum Toxin A 100 U | Drug | Botox |
Primary outcome
JRS (Jankovic Rating Scale) sum-score
Time frame: From baseline at 4 week
Change from baseline at 4 week for the JRS (Jankovic Rating Scale) sum-score
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 13 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Essential Blepharospasm
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Blepharospasm of Both Eyelids, Blepharospasm of Left Eyelid
RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Benign Essential Blepharospasm, Hemifacial Spasm
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neuronox and Botox in people with Essential Blepharospasm, run by Medy-Tox.
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 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 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
JRS (Jankovic Rating Scale) sum-score (time frame: From baseline at 4 week). 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 13 Jul 2017.