Overview

This trial has been completed.

Condition bilateral blepharospasm (beb)
Treatments incobulinumtoxina (xeomin), 25 units, incobotulinumtoxina (xeomin), 12.5 units, placebo, incobotulinumtoxina (xeomin), 35 units
Phase phase 3
Sponsor Merz Pharmaceuticals GmbH
Start date November 2013
End date April 2016
Trial size 61 participants
Trial identifier NCT01896895, 2012-004821-26, MRZ60201_3074_1

Summary

This phase 3 study will serve to collect efficacy and safety data of two different doses of NT 201 in subjects suffering from Bilateral Blephorasm (BEB) who are BTX treatment-naïve.

In this study, BTX treatment-naïve subjects are defined as those who have not received BTX treatment within the last 12 months for the treatment of BEB. This definition aims to avoid bias by comparison of treatment effects in the subject's assessments. Furthermore, this study will substantiate the existing efficacy and safety database for the indication BEB.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Main Period: one injection session, 25 Units per eye. Open-Label Extension: one injection session, up to 35 Units per eye. Mode of administration: intramuscular injection.
incobulinumtoxina (xeomin), 25 units NT 201
IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 25 Units per eye.
incobotulinumtoxina (xeomin), 35 units NT 201
IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Open-Label Extension: up to 35 Units per eye.
(Experimental)
Main Period: one injection session, 12.5 Units per eye. Open-Label Extension Period: one injection session, up to 35 Units per eye. Mode of administration: intramuscular injection.
incobotulinumtoxina (xeomin), 12.5 units NT 201
IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 12.5 Units per eye.
incobotulinumtoxina (xeomin), 35 units NT 201
IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Open-Label Extension: up to 35 Units per eye.
(Placebo Comparator)
Main Period: Placebo to IncobotulinumtoxinA (Xeomin)(12.5 or 25U/eye), one injection session. Open-Label Extension: IncobotulinumtoxinA (Xeomin), one injection session, up to 35 Units per eye. Mode of administration: intramuscular injection.
placebo
Main Period: Placebo to IncobotulinumtoxinA (Xeomin), powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
incobotulinumtoxina (xeomin), 35 units NT 201
IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Open-Label Extension: up to 35 Units per eye.

Primary Outcomes

Measure
Change from baseline in Jankovic rating scale (JRS) severity subscore determined at V4 (Week 6)
time frame: Baseline to week 6

Secondary Outcomes

Measure
Change from baseline in Blepharospasm Disability Index (BSDI) score at Visit 4 (week 6)
time frame: Baseline to week 6
Patient Evaluation of Global Response [PEGR] at final visit of Main Period (V5 -up to week 20)
time frame: Up to week 20

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Male or female out-patients age ≥ 18 and ≤ 80 years. - A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of orbicular oculi muscles. - A need for injection of BTX defined as a Jankovic Rating Scale [JRS] severity subscore ≥ 2. - Treatment-naïve subject defined as at least 12 months without BTX of any serotype for the treatment of BEB before administration of IP. Exclusion Criteria: - Subject with any previous unsuccessful treatment with BTX of any serotype for the treatment of BEB. - Atypical variant of BEB (e.g., apraxia of the eyelid opening) caused by inhibition of levator palpebrae muscle. - Neuroleptic-induced blepharospasm. - Myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation, spinal cord stimulation) and surgery in the upper face. - Generalized disorders of muscles activity (e.g., myasthenia gravis in particular ocularis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis) or any other significant neuromuscular dysfunction which might interfere with the study.

Additional Information

Official title Prospective, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of Two Different Doses of NT 201 in Botulinum Toxin Treatment-naïve Subjects With Blepharospasm
Description Subjects to receive one injection with NT 201 or placebo at baseline of the placebo-controlled first cycle. Thereafter, all subjects entering the Open-Label Extension Period (OLEX) to receive a second injection of NT 201 (second injection cycle).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merz Pharmaceuticals GmbH.