NCT01896895 - Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

April 30, 2016

Study Completion Date

November 30, 2016

Conditions

Bilateral Blepharospasm (BEB)

Interventions

DRUG

IncobulinumtoxinA (Xeomin), 25 Units

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.

DRUG

IncobotulinumtoxinA (Xeomin), 12.5 Units

DRUG

Placebo

Main Period: Placebo to IncobotulinumtoxinA (Xeomin), powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

DRUG

IncobotulinumtoxinA (Xeomin), 35 Units

"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."

Trial Locations (11)

10250

Merz Investigational Site #094002, Nugegoda

10350

Merz Investigational Site #094005, Colombo

10990

Merz Investigational Site #060007, George Town

11521

Merz Investigational Site #030002, Athens

11526

Merz Investigational Site #030001, Athens

43000

Merz Investigational Site #060003, Kuala Selangor

50586

Merz Investigational Site #060006, Kuala Lumpur

56000

Merz Investigational Site #060002, Kuala Lumpur

60000

Merz Investigational Site #094006, Kurunegala

88586

Merz Investigational Site #060004, Kota Kinabalu

07

Merz Investigational Site #094001, Colombo