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MT10109L in the Long-term, Open-label Treatment of Glabellar Lines and Lateral Canthal 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: NCT04157686
Recruitment Status : Enrolling by invitation
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.

Condition or disease Intervention/treatment Phase
Glabellar Lines Lateral Canthal Lines Drug: MT10109L Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines
Actual Study Start Date : October 25, 2019
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : February 28, 2023

Arm Intervention/treatment
Experimental: MT10109L Dose 1
MT10109L Dose 1 will be injected into the GL.
Drug: MT10109L
MT10109L will be injected into either the GL, LCL, or both the LCL and GL.

Experimental: MT10109L Dose 2
MT10109L Dose 2 will be injected into the LCL.
Drug: MT10109L
MT10109L will be injected into either the GL, LCL, or both the LCL and GL.

Experimental: MT10109L Dose 1 + Dose 2
MT10109L Dose 1 will be injected into the GL and MT10109L Dose 2 will be injected into the LCL.
Drug: MT10109L
MT10109L will be injected into either the GL, LCL, or both the LCL and GL.




Primary Outcome Measures :
  1. Number of participants who experienced an adverse event [ Time Frame: Baseline to Day 720 ]
  2. Mean change from baseline in pulse rate (beats per minute) [ Time Frame: Baseline to Day 720 ]
  3. Mean change from baseline in blood pressure (mm Hg) [ Time Frame: Baseline to Day 720 ]
  4. Mean change from baseline in respiratory rate (breaths per minute) [ Time Frame: Baseline to Day 720 ]
  5. Number of participants with binding and neutralizing antibodies [ Time Frame: Baseline to Day 720 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of lead-in Phase 3 study
  • 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
  • Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157686


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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Christy Harutunian Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04157686     History of Changes
Other Study ID Numbers: MT10109L-004
2014-005303-24 ( EudraCT Number )
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No