DANTROLENE SODIUM for Glabellar lines

Inclusion criteria

• {"criterion_text":"- Provision of written informed consent prior to any study related procedures."}
• {"criterion_text":"- Female participants naïve for any toxins treatment, between 18 and 65 years of age inclusive."}
• {"criterion_text":"- Severe (Grade 3) vertical GL at maximum frown at Screening and Baseline (Day 1), as assessed by Investigator’s Live Assessment (ILA) using validated 4-point photographic scale (Beer et al., 2019)."}
• {"criterion_text":"- Severe (Grade 3) vertical GL at maximum frown at Screening and Baseline (Day 1), as assessed by the Subject Self-assessment (SSA) using validated 4-point photographic scale."}
• {"criterion_text":"- A negative pregnancy test (for females of childbearing potential only). Nonchildbearing female is defined as a premenopausal female with permanent sterility or permanent infertility due to one of the following: •\tPermanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy. •\tNon-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry for these individuals. Or defined as postmenopausal female; a postmenopausal state is defined as: •\tAge > 55 years with no menses for 12 or more months without an alternative medical cause. •\tAge ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone level > 30 International Unit/L. Females on hormone replacement therapy and whose menopausal status is in doubt, as determined by the investigator, will be required to use one of the non-hormonal (highly) effective contraception methods if they wish to continue their hormone replacement therapy during the study. Otherwise, they must discontinue hormone replacement therapy to allow confirmation of postmenopausal status before study enrolment."}
• {"criterion_text":"- Participant is willing and able to comply with the requirements of the protocol. In particular, participant must adhere to the visit schedule, concomitant and prohibited therapies, and instruction against sun or ultraviolet (UV) exposure."}

Exclusion criteria

• {"criterion_text":"- Any prior treatment with permanent fillers in the upper face including the GL area."}
• {"criterion_text":"- A history of facial nerve palsy."}
• {"criterion_text":"- Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin."}
• {"criterion_text":"- Any botulinum neurotoxin (BoNT) of any serotype injection."}
• {"criterion_text":"- Known allergy or hypersensitivity to BoNT or Dantrolene, or any excipients of FTP-501 or Onabotulinum toxin A (which includes human serum albumin)."}
• {"criterion_text":"- The presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgement of the investigator, might increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study."}
• {"criterion_text":"- A history of cardiovascular disease."}
• {"criterion_text":"- Participant is planning to sun-bath or to overexpose to UV-light (mountain sports, phototherapy, tanning salon use…) during the course of the study"}
• {"criterion_text":"- The participant is an adult, protected by the law (adults under guardianship, or hospitalized in a public or private institution for a reason other than the study, or incarcerated)"}
• {"criterion_text":"- Any prior treatment with long lasting dermal fillers in the face including the GL area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technique used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the past 12 months or thread lifting if procedure was performed at least 6 months ago; past history of lower face treatments with ultherapy are authorized."}
• {"criterion_text":"- Any planned facial cosmetic surgery during the study."}
• {"criterion_text":"- Pregnant or lactating women, or childbearing potential women not willing to practice a highly effective form of contraception method at the beginning of the study and for a minimum of 12 weeks following last administration of study treatment; women couple are not concerned by contraception methods and may be enrolled in the study if they fulfil the inclusion/exclusion criteria. Highly effective methods of contraception are defined as methods of birth control which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized partner (provided that it is the sole male sexual partner of the participant and that the vasectomized partner has received medical assessment of the surgical success), or abstinence (if in line with the preferred and usual lifestyle of the participant)."}
• {"criterion_text":"- A history of eyelid blepharoplasty or brow lift within the past 5 years."}
• {"criterion_text":"- An inability to substantially reduce GL by physically spreading them apart or lack of capacity to frown."}
• {"criterion_text":"- An active infection or other skin problems in the face including the GL area (e.g. acute acne lesions or ulcers)."}
• {"criterion_text":"- Use of concomitant therapy which, in the investigator’s opinion, would interfere with the evaluation of the safety or efficacy of the study treatment, including medications affecting bleeding disorders (antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases including calcium channel blocking agents, such as nifedipine, verapamil, and amlodipine) or potentially hepatotoxic medications/substances."}
• {"criterion_text":"- Use of medications that affect neuromuscular transmission, such as curare-like nondepolarizing agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days before baseline."}
• {"criterion_text":"- History of hepatic disease."}
• {"criterion_text":"- Participant with a pathology not compatible with the participation of the clinical study in the opinion of the investigator."}
• {"criterion_text":"- Positive for hepatitis B antigen, or hepatitis C virus antibody or for human immunodeficiency virus or had received diagnosis for acquired immunodeficiency syndrome."}
• {"criterion_text":"- Abnormal serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) liver function values (> 3 times upper limit of normal [ULN])."}
• {"criterion_text":"- A history of drug or alcohol abuse."}
• {"criterion_text":"- Treatment with an experimental drug or use of any experimental device within 30 days prior to the start of the study and during the conduct of the study"}
• {"criterion_text":"- Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant’s participation in the study in the opinion of the investigator."}

Primary endpoints

• {"endpoint_text":"- Part1: •\tPercentage of responders with at least +1 grade of improvement from baseline on ILA at each post-treatment visit (at maximum frown and at rest).","definition_or_measurement_approach":"Assessed by Investigator’s Live Assessment (ILA) using a validated 4-point photographic scale (Beer et al., 2019); responder defined as at least +1 grade improvement from baseline at each post-treatment visit."}
• {"endpoint_text":"- Part 1: •\tPercentage of responders with at least +1 grade of improvement from baseline on SSA at each post-treatment visit (at maximum frown and at rest).","definition_or_measurement_approach":"Assessed by Subject Self-assessment (SSA) using a validated 4-point photographic scale; responder defined as at least +1 grade improvement from baseline at each post-treatment visit."}
• {"endpoint_text":"- Part 1: •\tPercentage of responders with at least +2 grade of improvement from baseline on ILA at each post-treatment visit (maximum frown and at rest).","definition_or_measurement_approach":"Assessed by ILA using validated 4-point photographic scale; responder defined as at least +2 grade improvement from baseline."}
• {"endpoint_text":"- Part 1: •\tPercentage of responders with at least +2 grade of improvement from baseline on SSA at each post-treatment visit (maximum frown and at rest).","definition_or_measurement_approach":"Assessed by SSA using validated 4-point photographic scale; responder defined as at least +2 grade improvement from baseline."}
• {"endpoint_text":"- Part 1: •\tDuration of treatment response based on the ILA at maximum frown (from D1 injection to return to baseline level) (for responders with at least +1 grade improvement from baseline).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline ILA score at maximum frown for responders (≥+1 grade)."}
• {"endpoint_text":"- Part 1: •\tDuration of treatment response based on the ILA at maximum frown (from D1 injection to return to baseline level) (for all participants where non-responders are treated as duration 0).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline ILA score at maximum frown; non-responders are counted as duration 0."}
• {"endpoint_text":"- Part 1: •\tDuration of treatment response based on the ILA at rest (from D1 injection to return to baseline level) (for responders with at least +1 grade improvement from baseline).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline ILA score at rest for responders (≥+1 grade)."}
• {"endpoint_text":"- Part 1: •\tDuration of treatment response based on the ILA at rest (from D1 injection to return to baseline level) (for all participants where non-responders are treated as duration 0).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline ILA score at rest; non-responders are counted as duration 0."}
• {"endpoint_text":"- Part 2: o\tDuration of treatment response based on the ILA at maximum frown (from D1 injection to return to baseline level) (for responders with at least +1 grade improvement from baseline).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline ILA score at maximum frown for responders (≥+1 grade) in Part 2 comparisons."}

Secondary endpoints

• {"endpoint_text":"- o\tPercentage of responders with at least +1 grade of improvement from baseline on ILA at maximum frown at 6 months","definition_or_measurement_approach":"Assessed by ILA at maximum frown at 6 months; responder defined as ≥+1 grade improvement from baseline."}
• {"endpoint_text":"- o\tPercentage of responders with at least +1 grade of improvement from baseline on ILA at each post-treatment visit (at maximum frown and at rest).","definition_or_measurement_approach":"Assessed by ILA using validated 4-point photographic scale at each post-treatment visit; responder = ≥+1 grade improvement."}
• {"endpoint_text":"- o\tPercentage of responders with at least +1 grade of improvement from baseline on SSA at each post-treatment visit (at maximum frown and at rest).","definition_or_measurement_approach":"Assessed by SSA using validated 4-point photographic scale at each post-treatment visit; responder = ≥+1 grade improvement."}
• {"endpoint_text":"- o\tPercentage of responders with at least +2 grade of improvement from baseline on ILA at each post-treatment visit (maximum frown and at rest).","definition_or_measurement_approach":"Assessed by ILA; responder = ≥+2 grade improvement from baseline at each post-treatment visit."}
• {"endpoint_text":"- o\tPercentage of responders with at least +2 grade of improvement from baseline on SSA at each post-treatment visit (maximum frown and at rest).","definition_or_measurement_approach":"Assessed by SSA; responder = ≥+2 grade improvement from baseline at each post-treatment visit."}
• {"endpoint_text":"- o\tPercentage of responders with a severity grade of “none” or “mild” (maximum frown and at rest) on ILA using each post-treatment visit.","definition_or_measurement_approach":"Assessed by ILA; proportion of participants achieving severity grade 'none' or 'mild' at post-treatment visits."}
• {"endpoint_text":"- o\tResponse to treatment as achieved by a score of “very much improved” or “much improved” or “Improved” on the participant’s GAIS at each post-treatment visit.","definition_or_measurement_approach":"Assessed by Participant Global Aesthetic Improvement Scale (GAIS) at each post-treatment visit; responders defined by specified GAIS categories."}
• {"endpoint_text":"- o\tTime to onset of treatment response with at least +1 improvement from baseline of ILA at maximum frown and at rest (Day 1 through Day 8).","definition_or_measurement_approach":"Measured as time (Day 1–Day 8) to first observation of ≥+1 grade improvement from baseline on ILA at maximum frown and at rest."}
• {"endpoint_text":"- o\tDuration of treatment response based on the ILA at maximum frown (from D1 injection to return to baseline level).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline ILA score at maximum frown."}
• {"endpoint_text":"- o\tThe duration of treatment response based on the ILA at rest (from D1 injection to return to baseline level).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline ILA score at rest."}
• {"endpoint_text":"- o\tThe duration of treatment response based on the ILA at rest (from D1 injection to return to baseline level).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline ILA score at rest."}
• {"endpoint_text":"- o\tThe duration of treatment response based on the SSA at maximum frown (from D1 injection to return to baseline level).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline SSA score at maximum frown."}
• {"endpoint_text":"- o\tThe duration of treatment response based on the SSA at maximum frown (from D1 injection to return to baseline level).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline SSA score at maximum frown."}
• {"endpoint_text":"- o\tThe duration of treatment response based on the SSA at rest (from D1 injection to return to baseline level).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline SSA score at rest."}
• {"endpoint_text":"- o\tThe duration of treatment response based on the SSA at rest (from D1 injection to return to baseline level).","definition_or_measurement_approach":"Measured as time from Day 1 injection to return to baseline SSA score at rest."}
• {"endpoint_text":"- o\tArea under the curve (AUC) of mean score of GL severity at maximum frown and at rest by ILA.","definition_or_measurement_approach":"Calculated AUC of mean GL severity scores assessed by ILA at maximum frown and at rest over follow-up."}
• {"endpoint_text":"- o\tAUC of mean score of GL severity at maximum frown and at rest by SSA.","definition_or_measurement_approach":"Calculated AUC of mean GL severity scores assessed by SSA at maximum frown and at rest over follow-up."}

Germany

Earliest CTIS Part Ii Submission Date

07-05-2024

Latest Decision Or Authorization Date

01-09-2025

Processing Time Days

482

Number Of Sites

5

Number Of Participants

116

Primary sponsor

Full Name

Fastox Pharma S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Third parties

• {"country":"United States","full_name":"Alta Analytical Laboratory Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Labor Fenner & Kollgen MVZ GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Health care"}
• {"country":"Germany","full_name":"Medios Manufaktur GmbH","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"SGS proderm GmbH","duties_or_roles":"sponsorDuties codes: [1,11,13,2,5,6,7]","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Universitaetsklinikum Schleswig-Holstein AöR","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Standardized photography","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Myonex GmbH","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Synerlab Developpement","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"MyData-TRUST","duties_or_roles":"sponsorDuties codes: [15]; value: Data protection officer","organisation_type":"Industry"}
• {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: ECG reading","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services Sàrl","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Health care"}