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SL-1002 for Spasticity (RAISE Trial)

Phase 2
Waitlist Available
Research Sponsored by Saol Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Male condom with intravaginally applied spermicide starting at least 21 days prior to study drug administration;
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of study drug administration to end of study visit (day 168)
Awards & highlights

RAISE Trial Summary

This trial is testing a new drug for safety, how it works in the body, and effectiveness for treating spasticity. 32 people will be enrolled and randomly assigned to either the new drug or a placebo. The study will last up to 26 weeks.

Eligible Conditions
  • Spasticity

RAISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
If you're a male, you need to use a condom with spermicide for at least 21 days before starting the study drug.

RAISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of study drug administration to end of study visit (day 168)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of study drug administration to end of study visit (day 168) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of treatment emergent adverse events (TEAEs) overall

RAISE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SL-1002Experimental Treatment1 Intervention
SL-1002 injectable solution, single dose
Group II: Matching placeboPlacebo Group1 Intervention
Matching placebo injectable solution, single dose

Find a Location

Who is running the clinical trial?

Saol Therapeutics IncLead Sponsor
2 Previous Clinical Trials
166 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this research project recruiting?

"Affirmative. Per the information on clinicaltrials.gov, this clinical trial is actively seeking participants and has been updated most recently at 9/2/2022 - it was initially posted 4/22/2022 with an aim to include 32 patients from 2 sites in total."

Answered by AI

Are there any prerequisites for participating in this research trial?

"This clinical experiment seeks 32 adults aged 18 to 80 who suffer from spasticity of either cortical or spinal origin, that can be managed via chemo denervation. Additional qualifications include: a MAS score for the related limbs and muscles greater than two; BMI between 18.0-29.9 kg/m2 with total body weight over 50kg (male) or 45.5kg (female); hormonal contraceptive use beginning at least four weeks prior to study drug administration; nonpregnant female participants with an intrauterine device in place since 4 weeks before study drugs are administered, male partners using condoms plus spermicides starting"

Answered by AI

Is this experiment open to participants older than 25 years of age?

"According to the study's criteria, participants must be 18 years or older and no more than 80 for enrolment."

Answered by AI

What dangers, if any, have been identified with the utilization of SL-1002?

"SL-1002 has been rated a 2 on the safety scale, as there have only been Phase 2 trials conducted thus far. Therefore, while some data is available to support its security parameters, no information exists indicating efficacy at this time."

Answered by AI

Is the sign-up window for this medical experiment still open?

"Affirmative. The clinical trial is currently in the process of recruiting participants, with a commencement date on April 22nd 2022 and an updated listing posted September 2nd 2022. 32 patients will be sought from two separate medical sites."

Answered by AI
~11 spots leftby Mar 2025