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Fatty Acid
Docosahexaenoic Acid for Sickle Cell Disease (SCOT Trial)
Phase 2
Waitlist Available
Led By Matthew Heeney, MD
Research Sponsored by Micelle BioPharma Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 (baseline) through month 52 (end of treatment)
Awards & highlights
SCOT Trial Summary
This study is evaluating whether a drug can improve the health of children with sickle cell disease.
Eligible Conditions
- Sickle Cell Disease
SCOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 (baseline) through month 52 (end of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 (baseline) through month 52 (end of treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate safety & tolerability of SC411 & determine change from Baseline in the blood cells omega-3 fatty acids index in subjects, treated with active SC411 doses or placebo in Part A and safety and tolerability in Part B.
Secondary outcome measures
Measurement of the pharmacokinetic (PK) parameter of AUC will be performed for three dose levels of SC411 will be measured.
Measurement of the pharmacokinetic (PK) parameter of Cmax will be performed for three dose levels of SC411 will be measured.
Measurement of the pharmacokinetic (PK) parameter of Tmax will be performed for three dose levels of SC411 will be measured.
+1 moreOther outcome measures
The intensity of painful crises on a scale of 0 to 10, reported by subjects receiving one of the three oral dose levels of SC411 compared to matching placebo will be evaluated from eDiary-records of patient reported outcomes.
The number of blood transfusions on subjects receiving one of the three oral dose levels of SC411 compared to matching placebo will be evaluated.
The number of painful crises had by subjects receiving one of the three oral dose levels of SC411 compared to matching placebo will be evaluated from eDiary-records of patient reported outcomes.
+2 moreSide effects data
From 2020 Phase 2 trial • 65 Patients • NCT018492506%
Anemia
6%
Gastrointestinal disorders - Other: Burping
6%
Headache
3%
Fall
3%
Back pain
3%
Bruising
3%
Dyspepsia - Heart Burn
3%
Gastroesophageal reflux disease
3%
Allergic rhinitis
3%
Breast pain
3%
Diarrhea
3%
Flu like symptoms
3%
Myalgia
3%
Flatulence
3%
Localized edema
3%
Pain
3%
Respiratory, thoracic and mediastinal disorders - Other, Chest Congestion
3%
Sinusitis
3%
Skin infection
3%
Sore throat
3%
Urticaria
3%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Docosahexaenoic Acid
SCOT Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose Level 3Experimental Treatment1 Intervention
Target dose 60 mg/kg Docosahexaenoic acid
Group II: Dose Level 2Experimental Treatment1 Intervention
Target dose 36 mg/kg Docosahexaenoic acid
Group III: Dose Level 1Experimental Treatment1 Intervention
Target dose 20 mg/kg Docosahexaenoic acid
Group IV: PlaceboPlacebo Group1 Intervention
Soybean oil
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doconexent
FDA approved
Find a Location
Who is running the clinical trial?
Micelle BioPharma IncLead Sponsor
1 Previous Clinical Trials
210 Total Patients Enrolled
Matthew Heeney, MDPrincipal InvestigatorBoston Children's Hospital
2 Previous Clinical Trials
1,657 Total Patients Enrolled
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