BlepharospasmPhase 4NCT00761592
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
A Phase 4 study testing Botulinum Toxin Type A 900kDa and Botulinum Toxin Type A 150kDa in people with Blepharospasm, run by Allergan at 3 sites in Germany.
Trial summary
This pilot study estimates the treatment effects of two different types of botulinum toxin type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharospasm
- What is being tested?
- Botulinum Toxin Type A 900kDa and Botulinum Toxin Type A 150kDa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2006to Jan 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosed with benign essential blepharospasm
- Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required, in the investigators opinion, the same dose at the study injection visit.
- Combined Jankovic Rating Score of >2
Who cannot join
- Female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing birth control.
- Profound atrophy of the muscles in the target area(s) of injection.
- Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
- Known significantly impaired renal and/or hepatic function
Trial locations and contacts
3 sites in 1 country.
About this study
This pilot study estimates the treatment effects of two different types of botulinum toxin type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids.
- Conditions
- Blepharospasm
- Being tested
- Botulinum Toxin Type A 900kDa, Botulinum Toxin Type A 150kDa
- Medical subject headings
- Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A 900kDaBiological
Also called BOTOX®
6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose)
Botulinum Toxin Type A 150kDaBiological
Also called Xeomin®
6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Biological: Botulinum Toxin Type A 900kDa |
| 2 | Active comparator | Not described Receives: Biological: Botulinum Toxin Type A 150kDa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 4 in Blepharospasm Disability Index
Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle).
0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.
The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement.
Measured: Baseline to Week 4
Secondary outcomes (4)
Change From Baseline to Week 8 in Blepharospasm Disability Index
Blepharospasm Disability Index is a validated 5-point (0-4) scale with six items (e.g., reading, driving a vehicle).
0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.
The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement.
Measured: Baseline to Week 8
Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)
Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open > 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.
Measured: Baseline to Week 4 and Week 8
Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score
Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect
+1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement.
Measured: Baseline to Week 4 and 8
Duration of Action
Median Duration for decision to reinject
Measured: Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startJul 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761592
- Sponsor's protocol ID
- ALLBL001
- Status last verified
- Oct 2013
- First submitted
- 25 Sep 2008
- Last updated
- 19 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
- ClinicalTrials.gov ID
- NCT00761592
- Acronym / sponsor ID
- ALLBL001
- Conditions
- Blepharospasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Posted 9 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study estimates the treatment effects of two different types of botulinum toxin type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Botulinum Toxin Type A 900kDa |
| 2 | Active comparator | Biological: Botulinum Toxin Type A 150kDa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with benign essential blepharospasm
- Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required, in the investigators opinion, the same dose at the study injection visit.
- Combined Jankovic Rating Score of >2
Key exclusion criteria (4 listed)
- Female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing birth control.
- Profound atrophy of the muscles in the target area(s) of injection.
- Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
- Known significantly impaired renal and/or hepatic function
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 900kDaAlso: BOTOX®6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose) | Biological | 1 |
| Botulinum Toxin Type A 150kDaAlso: Xeomin®6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose) | Biological | 2 |
Primary outcome
Change From Baseline to Week 4 in Blepharospasm Disability Index
Time frame: Baseline to Week 4
Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle). 0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable. The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement.
4 secondary outcomes
Change From Baseline to Week 8 in Blepharospasm Disability Index
Time frame: Baseline to Week 8
Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)
Time frame: Baseline to Week 4 and Week 8
Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score
Time frame: Baseline to Week 4 and 8
Duration of Action
Time frame: Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Blepharospasm
RecruitingPhase 2
DaxibotulinumtoxinA for Blepharospasm
Blepharospasm of Both Eyelids, Blepharospasm of Left Eyelid
RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Benign Essential Blepharospasm, Hemifacial Spasm
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.
Medical Director study director
Allergan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A 900kDa and Botulinum Toxin Type A 150kDa in people with Blepharospasm, run by Allergan at 3 sites in Germany.
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: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline to Week 4 in Blepharospasm Disability Index (time frame: Baseline to Week 4). 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 19 Nov 2013.