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Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition
Phase 2
Waitlist Available
Led By Rhonda Voskuhl, M.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
All Individual Drugs Already Approved
Summary
This trial tests whether an estrogen pill called estriol can improve thinking and memory in women with Multiple Sclerosis (MS). About half of people with MS have cognitive problems, and there are no approved treatments for this. Estriol levels are higher during pregnancy and may help protect the brain. Estriol treatment is anti-inflammatory and neuroprotective in preclinical studies, and has shown promise in reducing MS relapses in small studies. The study will compare estriol plus standard MS treatments to another group over several months.
Eligible Conditions
- Multiple Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in cognitive function assessed by Paced Serial Addition Test (PASAT).
Secondary study objectives
Change from baseline in cognitive function as assessed by a brief battery of cognitive tests.
Change from baseline in cognitive function as assessed by cognitive evoked potentials, measured in milliseconds.
Change from baseline in standard MS outcome measures.
+1 moreSide effects data
From 2017 Phase 2 trial • 61 Patients • NCT024130086%
Urinary tract infection
2%
Lymphoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.005% Estriol Vaginal Gel
Placebo Vaginal Gel
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: EstriolExperimental Treatment2 Interventions
Standard MS Treatment + Estriol
Group II: Group B: PlaceboPlacebo Group2 Interventions
Standard MS Treatment + Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estriol
FDA approved
Norethisterone
FDA approved
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,567 Previous Clinical Trials
10,266,936 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
285 Patients Enrolled for Multiple Sclerosis
Rhonda Voskuhl, M.D.5.01 ReviewsPrincipal Investigator - University of California, Los Angeles
University of California, Los Angeles
2 Previous Clinical Trials
168 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
168 Patients Enrolled for Multiple Sclerosis