NCT01466114

A Double-Blind, Placebo Controlled Trial of Estriol Treatment in Women With Multiple Sclerosis: Effect on Cognition.

Status unknown Phase 2 Last updated 4 November 2019

What this trial tests

Phase 2 trial testing estriol in Relapsing-remitting Multiple Sclerosis in 64 participants. Status unknown.

Timeline

1 October 2011

Primary endpoint
1 December 2021

1 April 2022

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	64
Start date	1 October 2011
Primary completion	1 December 2021
Estimated completion	1 April 2022
Sites	4 locations across United States

Drugs / interventions tested

• estriol (ESTRIOL) — full drug profile →
• Placebo
• Norethindrone — full drug profile →
• Progestin Placebo

Conditions studied

• Relapsing-remitting Multiple Sclerosis — all drugs for Relapsing-remitting Multiple Sclerosis →
• Secondary-progressive Multiple Sclerosis — all drugs for Secondary-progressive Multiple Sclerosis →
• Primary-progressive Multiple Sclerosis — all drugs for Primary-progressive Multiple Sclerosis →

Sponsor

University of California, Los Angeles

Who can join

Adults 18 to 55, female only, with Relapsing-remitting Multiple Sclerosis or Secondary-progressive Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline in cognitive function assessed by Paced Serial Addition Test (PASAT).
  Time frame: 1 year
  Processing speed will be assessed by PASAT. Numerical test scores (ranging from 0-60) will be acquired, then percent change for each subject at trial conclusion as compared to baseline will be determined. Whether greater improvement as expressed as percent change occurs in the estriol group as compared to the placebo group will be determined.

Sponsor's own description

Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pregnancy: Effect on Multiple Sclerosis, Treatment Considerations, and Breastfeeding.
   Voskuhl R, Momtazee C. · · 2017 · cited 59× · PMID 28766273 · DOI 10.1007/s13311-017-0562-7
2. Oestrogen receptor β ligand acts on CD11c+ cells to mediate protection in experimental autoimmune encephalomyelitis.
   Kim RY, Mangu D, Hoffman AS, Kavosh R, et al · · 2018 · cited 43× · PMID 29228214 · DOI 10.1093/brain/awx315
3. Estriol-mediated neuroprotection in multiple sclerosis localized by voxel-based morphometry.
   MacKenzie-Graham A, Brook J, Kurth F, Itoh Y, et al · · 2018 · cited 24× · PMID 30144306 · DOI 10.1002/brb3.1086
4. Estrogen receptor-β ligand treatment after disease onset is neuroprotective in the multiple sclerosis model.
   Wisdom AJ, Cao Y, Itoh N, Spence RD, et al · · 2013 · cited 23× · PMID 23633287 · DOI 10.1002/jnr.23219
5. Pharmacological treatment for memory disorder in multiple sclerosis.
   He D, Zhang Y, Dong S, Wang D, et al · · 2013 · cited 20× · PMID 24343792 · DOI 10.1002/14651858.cd008876.pub3
6. Hormonal Therapies in Multiple Sclerosis: a Review of Clinical Data.
   Hsu S, Bove R. · · 2024 · cited 19× · PMID 38102502 · DOI 10.1007/s11910-023-01326-7