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SpasticityPhase 2RAISENCT05311215

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

A Phase 2 study testing SL-1002 in people with Spasticity, run by Saol Therapeutics Inc at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Spasticity
What is being tested?
SL-1002
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
2 sitesUnited States
Study dates
22 Apr 2022to Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Spasticity based on MAS of greater than or equal to 2 in the specified limbs and muscle groups.
  • Patients who are diagnosed with spasticity of cerebral or spinal origin that can be treated with chemo denervation of the approved cohort-specific nerves. Prior history of chemo denervation must align with Exclusion #3 and #5 as noted below.
  • 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:
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  • 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
  • Documented bilateral oophorectomy.
  • Patients who are mentally coherent and responsive to communication, instructional command and have the ability to communicate proactively as defined by a Mini Mental State Examination (MMSE) score of 18 or greater. Patients can be enrolled into the study with or without the assistance of a caregiver based upon Investigator discretion. Patients who are cognitively compromised will be required to have a legally authorized representative consent for the study on their behalf.
  • Patients who have a positive response to baseline screening of 2-8mL lidocaine 1% solution administration.
  • Patients with no prior history or significant trauma to the injected limbs.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • 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.
  • Patients with clinically significant laboratory results at the Screening Visit (as judged by the Principal Investigator).
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • TIRR Memorial Hermann Research Center

    Houston, Texas, 77030

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Escalation Study to Assess the Safety, Pharmacokinetics and Efficacy of SL-1002 in Patients With Limb Spasticity

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
Being tested
SL-1002, Placebo
Medical subject headings
Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SL-1002Drug

    SL-1002 injectable solution

  • PlaceboDrug

    Matching placebo injectable solution

Study groups in NCT05311215
Study groupRoleWhat they receive
SL-1002ExperimentalSL-1002 injectable solution, single dose
Receives: Drug: SL-1002
Matching placeboPlacebo comparatorMatching placebo injectable solution, single dose
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start22 Apr 2022
  3. Primary completionSep 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05311215
Sponsor's protocol ID
Saol 1002-01
Acronym
RAISE
Status last verified
Sep 2023
First submitted
28 Mar 2022
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SL-1002 in people with Spasticity, run by Saol Therapeutics Inc at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of treatment emergent adverse events (TEAEs) overall (time frame: time of study drug administration to end of study visit (day 168)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05311215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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