A Phase 3 interventional study of incobotulinumtoxinA (Xeomin) and Placebo in Blepharospasm, sponsored by Merz Pharmaceuticals GmbH. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-03-15.
Sponsored by Merz Pharmaceuticals GmbH (part of Merz Pharma) · Phase 3, Interventional, and Treatment
Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.
42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's enrollment of 109 is above the median of 40 across 28 interventional studies indexed under Blepharospasm.
Browse Blepharospasm studies →Merz Pharmaceuticals GmbH is the lead sponsor of 61 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to 50 Units per eye; Open-Label Extension Period: up to 5 injections, up to 50 Units per eye per injection session; Mode of administration: intramuscular injection
Drug: incobotulinumtoxinA (Xeomin)
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
Drug: Placebo
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater)
The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale: * JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity) * JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 6
Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary)
The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale: * JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity) * JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 6
Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection
The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 6
Patient Evaluation of Global Response (PEGR) at Final Visit
The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4).
Time frame: Final visit (up to week 20 after injection of the Main Period)
| Milestone | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Started | 75 | 34 |
| Completed | 70 | 32 |
| Not completed | 5 | 2 |
| Withdrew: Withdrawal criteria occurred | 4 | 0 |
| Withdrew: Consent withdrawn | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Dosing error at visit 2 (baseline) | 0 | 1 |
| Milestone | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Started | 102 | 0 |
| Completed | 82 | 0 |
| Not completed | 20 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Consent withdrawn | 6 | 0 |
| Withdrew: Withdrawal criteria occurred | 4 | 0 |
| Withdrew: Lack of efficacy | 4 | 0 |
| Withdrew: Subjects needed further injection | 1 | 0 |
| Withdrew: Subject received botox injection | 1 | 0 |
| Withdrew: Injection in wrong muscle | 1 | 0 |
| Withdrew: Olex drug given at baseline | 1 | 0 |
The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale: * JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity) * JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
| Points on a scale | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) | -0.8 ± 0.13 | 0.2 ± 0.18 |
The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale: * JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity) * JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
| Points on a scale | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary) | -0.75 ± 1.24 | 0.16 ± 1.07 |
The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
| Points on a scale | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection | -0.4 ± 0.69 | 0.11 ± 0.67 |
The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4).
| Points on a scale | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Patient Evaluation of Global Response (PEGR) at Final Visit | 1.3 ± 2.09 | -0.6 ± 2.16 |
Collected over All SAEs/AEs during Double-Blind Period After Injection, i.e. up to 6-20 weeks after Main Period injection.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | — | 0/74 (0%) | 45/74 (60.8%) |
| Placebo | — | 1/34 (2.9%) | 13/34 (38.2%) |
| Event | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/74 | 1/34 |
| Event | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Dry eyeEye disorders | 14/74 | 4/34 |
| Eyelid ptosisEye disorders | 14/74 | 2/34 |
| Dry mouthGastrointestinal disorders | 11/74 | 1/34 |
| HeadacheNervous system disorders | 7/74 | 1/34 |
| Upper respiratory tract infectionInfections and infestations | 1/74 | 3/34 |
| DiarrhoeaGastrointestinal disorders | 6/74 | 0/34 |
| Visual disturbanceEye disorders | 6/74 | 0/34 |
| Respiratory tract infectionInfections and infestations | 5/74 | 1/34 |
| DysphagiaGastrointestinal disorders | 3/74 | 2/34 |
| NasopharyngitisInfections and infestations | 4/74 | 2/34 |
| Age Continuous(years) | incobotulinumtoxinA (Xeomin) | Placebo | Total |
|---|---|---|---|
| Mean | 61.5 ± 11.0 | 62.6 ± 8.7 | 61.9 ± 10.3 |
| Sex: Female, Male(Participants) | incobotulinumtoxinA (Xeomin) | Placebo | Total |
|---|---|---|---|
| Female | 49 | 22 | 71 |
| Male | 26 | 12 | 38 |
The record gives a start of Oct 2006, a primary completion of Apr 2008 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2010, 2 years 7 months after primary completion.
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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A