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

Exclusion Criteria

• •1. 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.
• •2. Patients with severe muscle atrophy in the targeted limbs.
• •3. 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.
• •4. 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.
• •5. 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.
• •6. Patients with bleeding disorders or who are being treated with anticoagulants.
• •7. Patients with severe hepatic or renal impairment that, in the judgement of the Principal Investigator, will preclude participation in the study.
• •8. Female patients who are pregnant or planning to become pregnant during the duration of the study.
• •9. Female patients who are breast-feeding.
• •10. Patients who are unable or unwilling to comply with the requirements of the protocol.
• •11. Patients taking any of the following concurrent medications/over-the counter products (refer to Appendix 7 for a list of applicable medications):
• •1. Probenecid or other OAT3 inhibitors.
• •2. Inhibitors of CYP2E1, such as disulfiram.
• •12. Patients with known allergies or hypersensitivity to phenol and/or lidocaine and/or their excipients.
• •13. Documented history or evidence of alcohol or drug abuse within 1 year of the Screening Visit.
• •14. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days of the Screening Visit, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
• •15. Patients with clinically significant ECG abnormalities or vital sign abnormalities at the Screening Visit. Patients with ECG or vital sign abnormalities deemed non-clinically significant or unlikely to result in clinical compromise by the Principal Investigator may be considered for study inclusion.
• •16. Patients with clinically significant laboratory results at the Screening Visit (as judged by the Principal Investigator).
• •17. Any condition, in the opinion of the Principal Investigator, that may pose a significant risk to the patient, confound the results of the study or interfere significantly with the patient's participation in the study.