Phase II Study to Assess Safety, Pharmacokinetics and Efficacy of SL-1002 for Limb Spasticity

NCT05311215 | Unknown Phase 2 FDA Drug

• 1 other identifier: Saol 1002-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, double-blind, placebo-controlled single ascending dose escalation study intended to assess the safety, pharmacokinetics and efficacy of single treatment of SL-1002 in patients with mild to severe limb spasticity. The study will enroll 4 cohorts of 8 patients per cohort for a total of 32 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio. The study period will be up to 26 weeks inclusive of a screening period of up to 2 weeks.

Conditions

Spasticity

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment emergent adverse events (TEAEs) overall

  TEAE timepoints will be observed from the time point of administration of total dose until end of study visit (day 168)

  time of study drug administration to end of study visit (day 168)

Study Arms (2)

SL-1002

EXPERIMENTAL

SL-1002 injectable solution, single dose

Drug: SL-1002

Matching placebo

PLACEBO COMPARATOR

Matching placebo injectable solution, single dose

Drug: Placebo

Interventions

SL-1002 DRUG

SL-1002 injectable solution

SL-1002

Placebo DRUG

Matching placebo injectable solution

Matching placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spasticity based on MAS of greater than or equal to 2 in the specified limbs and muscle groups.
• Patients who have had spasticity for greater than 6 months and have not had a significant change in their spasticity during recent evaluations or changes in dosing of spasticity medication in the 2 weeks prior to the Screening visit.
• Male or female patients between 18-80 years of age, with a Body Mass Index (BMI) of 18.0 to 29.9 kg/m2 and a total body weight of ≥50.0 kg for males and ≥45.5 kg for females.
• Female patients who are not pregnant.
• Female patients of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
• Intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration;
• Male condom with intravaginally applied spermicide starting at least 21 days prior to study drug administration;
• Hormonal contraceptives starting at least 4 weeks prior to study drug administration must agree to use the same hormonal contraceptive throughout the study;
• Sterile male partner (vasectomized since at least 6 months);
• Female patients of non-childbearing potential as defined below:
• Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] and estradiol levels consistent with menopause).
• Pre-menopausal females with one of the following:
• Documented tubal ligation
• Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
• Hysterectomy

You may not qualify if:

• Muscle contractures of the targeted upper or lower limb joints or any challenge that causes severe restriction of range of motion of targeted joints. Contractures will be identified by the Investigator following the lidocaine block by assessing the response.
• Patients with severe muscle atrophy in the targeted limbs.
• Patients who have had long-term treatments to block nerves (alcohol, phenol, etc.) that will be targeted in the study within 1 year of the Screening visit.
• Patients currently on intrathecal or oral baclofen therapy for spasticity who have not been on a stable dose regimen for at least 2 weeks prior to the Screening Visit or who would need to have significant dose adjustments at any time point during study participation.
• Patients who have received any botulinum toxin in the targeted muscle groups for the nerve block treatment within 6 months of the Screening Visit. Note: patients will not be able to receive any botulinum toxin injections to the targeted muscle group from the Screening Visit to the End of Study visit.
• Patients with bleeding disorders or who are being treated with anticoagulants.
• Patients with severe hepatic or renal impairment that, in the judgement of the Principal Investigator, will preclude participation in the study.
• Female patients who are pregnant or planning to become pregnant during the duration of the study.
• Female patients who are breast-feeding.
• Patients who are unable or unwilling to comply with the requirements of the protocol.
• Patients taking any of the following concurrent medications/over-the counter products (refer to Appendix 7 for a list of applicable medications):
• Probenecid or other OAT3 inhibitors.
• Inhibitors of CYP2E1, such as disulfiram.
• Patients with known allergies or hypersensitivity to phenol and/or lidocaine and/or their excipients.
• Documented history or evidence of alcohol or drug abuse within 1 year of the Screening Visit.

Sponsors & Collaborators

• Saol Therapeutics Inc: lead

Study Sites (2)

TIRR Memorial Hermann Research Center

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: April 22, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

US (2)