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Trial record 1 of 1 for:    MT10109L-001
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MT10109L in the Treatment of Glabellar Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03795922
Recruitment Status : Active, not recruiting
First Posted : January 8, 2019
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE January 8, 2019
Last Update Posted Date April 6, 2020
Actual Study Start Date  ICMJE December 24, 2018
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
The proportion of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) according to investigator and participant assessments of GL severity at maximum frown at Day 30 [ Time Frame: Day 30 ]
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2019)
The proportion of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) according to investigator and participant assessments of GL severity at maximum frown at Day 30 [ Time Frame: Day 30 ]
The investigator and participant evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • The duration of GL treatment in participants who achieved a rating of ≥ 2-grade improvement from baseline in GL severity at maximum frown at Day 30 according to investigator assessments using the FWS [ Time Frame: Day 1 (first treatment) to Day 180 ]
    The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
  • The proportion of responders for investigator assessments of GL severity at maximum frown using the FWS [ Time Frame: Day 30 ]
    The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe
  • The proportion of participants reporting mostly satisfied/very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 for GL [ Time Frame: Day 60 ]
    The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.
  • The proportion of responders for investigator assessments of GL severity at rest using the FWS [ Time Frame: Day 30 ]
    The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
  • Number of patients who experienced an adverse event [ Time Frame: From Consent (Screening Visit) up to Day 420 ]
  • Mean change from baseline in vital signs [ Time Frame: Baseline to Day 360 ]
  • Mean change from baseline in Electrocardiogram (ECG) parameters [ Time Frame: Baseline to Day 360 ]
  • Number of participants with binding and neutralizing antibodies [ Time Frame: Day 360 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2019)
  • The duration of GL treatment effect in participants who achieved a rating of ≥ 2-grade improvement from baseline in GL severity at maximum frown at Day 30 according to investigator assessments using the FWS [ Time Frame: Day 1 (first treatment) to Day 180 ]
    The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
  • The proportion of responders for investigator assessments of GL severity at maximum frown using the FWS [ Time Frame: Day 30 ]
    The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe
  • The proportion of participants reporting mostly satisfied/very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 for GL [ Time Frame: Day 60 ]
    The Satisfaction Question 5 grades frown line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.
  • The proportion of responders for investigator assessments of GL severity at rest using the FWS [ Time Frame: Day 30 ]
    The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MT10109L in the Treatment of Glabellar Lines
Official Title  ICMJE A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines
Brief Summary To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Glabellar Lines
Intervention  ICMJE
  • Drug: MT10109L
    MT10109L will be injected into the GL.
    Other Name: NivobotulinumtoxinA
  • Drug: Placebo
    Placebo will be injected into the GL.
Study Arms  ICMJE
  • Experimental: MT10109L
    MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
    Intervention: Drug: MT10109L
  • Placebo Comparator: Placebo
    Placebo will be injected into the GL: initial double-blind treatment on Day 1.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 17, 2020)
234
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2019)
225
Estimated Study Completion Date  ICMJE January 31, 2021
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

• Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

Exclusion Criteria

  • Known immunization or hypersensitivity to any botulinum toxin serotype.
  • Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
  • History of facial nerve palsy.
  • Any uncontrolled systemic disease.
  • Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
  • Anticipated need for surgery or overnight hospitalization during the study.
  • Prior exposure to botulinum toxin of any serotype for any reason.
  • Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).
  • Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
  • Females who are pregnant, nursing, or planning a pregnancy during the study.
  • Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03795922
Other Study ID Numbers  ICMJE MT10109L-001
2018-004384-31 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joan-En Lin Allergan
PRS Account Allergan
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP