Clinical trial

A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines

Name

MT10109L-004

Description

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.

Trial arms

Trial start

2019-10-23

Estimated PCD

2023-02-16

Trial end

2023-02-16

Status

Completed

Phase

Early phase I

Treatment

MT10109L Dose 1

MT10109L Dose 1 will be injected into the GL area

Arms:

MT10109L Dose 1/Dose 1, Placebo/MT10109L Dose 1

MT10109L Dose 2

MT10109L Dose 2 will be injected into the LCL area

Arms:

MT10109L Dose 2/Dose 2, Placebo/MT10109L Dose 2

MT10109L Dose 1 + Dose 2

MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area

Arms:

MT10109L Dose 1+2/Dose 1+2, MT10109L Dose 1/Dose 1+2, MT10109L Dose 2/Dose 1+2, Placebo/MT10109L Dose 1 + Dose 2

Size

957

Primary endpoint

Number of participants who experienced an adverse event

Baseline to Day 720

Mean change from baseline in pulse rate (beats per minute)

Baseline to Day 720

Mean change from baseline in blood pressure (mm Hg)

Baseline to Day 720

Mean change from baseline in respiratory rate (breaths per minute)

Baseline to Day 720

Number of participants with binding and neutralizing antibodies

Baseline to Day 720

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 957, 'type': 'ACTUAL'}}

Updated at

2024-03-06

1 organization

1 product

2 indications

Product

Indication

Indication

Organization