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Cannabinoid Receptor Agonist
EHP-101 low dose twice a day for Systemic Sclerosis
Phase 2
Recruiting
Research Sponsored by Emerald Health Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 85 and day 113
Awards & highlights
Study Summary
This trial is testing a new drug for safety and effectiveness in treating a skin condition called systemic sclerosis.
Eligible Conditions
- Systemic Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 85 and day 113
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 85 and day 113
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of Treatment Emergent Adverse Events
Secondary outcome measures
Treatment effect of EHP-101 compared to placebo as measured by the American College of Rheumatology composite response index in diffuse cutaneous Systemic Sclerosis
Treatment effect of EHP-101 compared to placebo in Scleroderma Health Assessment Questionnaire - Disability Index
Treatment effect of EHP-101 compared to placebo in forced vital capacity percent predicted
+3 moreOther outcome measures
Change from baseline of EHP-101 compared to placebo in 5 dimensions Itch Score
Change from baseline of EHP-101 compared to placebo in Functional Assessment of Chronic Illness Therapy: Fatigue
Change from baseline of EHP-101 compared to placebo in Patient-Reported Outcomes Measurement Information system-29 Short
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: EHP-101 low dose twice a dayExperimental Treatment1 Intervention
Group II: EHP-101 low dose once a dayExperimental Treatment1 Intervention
Group III: EHP-101 high dose twice a dayExperimental Treatment1 Intervention
Group IV: EHP-101 high dose once a dayExperimental Treatment1 Intervention
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Who is running the clinical trial?
Emerald Health PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
154 Total Patients Enrolled
Frequently Asked Questions
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