BlepharospasmPhase 2/3NCT02947815
Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm
A Phase 2/3 study testing Clostridium Botulinum Toxin Type A in people with Blepharospasm, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of essential blepharospasm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharospasm
- What is being tested?
- Clostridium Botulinum Toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Jan 2018
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male of female of at least 18 years old
- Grade 2~4 in Scott's scale
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
the catholic university of korea, Seoul ST. Mary's Hospital.
Seoul
About this study
Official title: A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase II/III Clinical Trial to Compare the Safety and Efficacy of NABOTA Versus BOTOX in Treatment of Essential Blepharospasm
The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of essential blepharospasm
- Conditions
- Blepharospasm
- Being tested
- Clostridium Botulinum Toxin Type A
- Medical subject headings
- Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium Botulinum Toxin Type ADrug
Also called NABOTA
Clostridium Botulinum Toxin Type ADrug
Also called BOTOX
| Study group | Role | What they receive |
|---|---|---|
| NABOTA | Experimental | Single-dose Receives: Drug: Clostridium Botulinum Toxin Type A |
| BOTOX | Active comparator | Single-dose Receives: Drug: Clostridium Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in Scott's Scale Score
Measured: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharospasmStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947815
- Sponsor's protocol ID
- DW_DWP450007
- Status last verified
- Jun 2019
- First submitted
- 24 Oct 2016
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase II/III Clinical Trial to Compare the Safety and Efficacy of NABOTA Versus BOTOX in Treatment of Essential Blepharospasm
- ClinicalTrials.gov ID
- NCT02947815
- Acronym / sponsor ID
- DW_DWP450007
- Conditions
- Blepharospasm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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.
The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of 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 |
|---|---|---|
| NABOTA | Experimental | Drug: Clostridium Botulinum Toxin Type ASingle-dose |
| BOTOX | Active comparator | Drug: Clostridium Botulinum Toxin Type ASingle-dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male of female of at least 18 years old
- Grade 2~4 in Scott's scale
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Clostridium Botulinum Toxin Type AAlso: NABOTA | Drug | NABOTA |
| Clostridium Botulinum Toxin Type AAlso: BOTOX | Drug | BOTOX |
Primary outcome
The change from baseline in Scott's Scale Score
Time frame: At 4 weeks
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 26 Jun 2019.
- Individual participant dataSharing planned: No
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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. 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 2/3 study testing Clostridium Botulinum Toxin Type A in people with Blepharospasm, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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 0 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 26 Jun 2019. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The change from baseline in Scott's Scale Score (time frame: At 4 weeks). 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 26 Jun 2019.