Estriol-MS
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Confirmed Relapse, Annualized Relapse Rate | Rate ratio 0.63 | 0.37–1.05 | 0.077 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Estriol
Estrogen receptor modulator
- Glatiramer acetate
Unknown
Placebo or sham
- Placebo
Results by group
Confirmed Relapse, Annualized Relapse Rate
24 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Estriol Capsules Plus Copaxone Injections | 0.25 relapses per year | 0.17–0.37 | 82 |
| Placebo Capsules Plus Copaxone Injections | 0.37 relapses per year | 0.25–0.53 | 76 |
Estriol Capsules Plus Copaxone Injections
Placebo Capsules Plus Copaxone Injections
p = 0.077; Rate ratio 0.63 (95% CI 0.37–1.05)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Estriol Capsules Plus Copaxone Injections | 82 | 8 (9.8%) | |
| Placebo Capsules Plus Copaxone Injections | 76 | 10 (13.2%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Confirmed Relapse, Annualized Relapse Rate
24 months
Disability progressionRelapsesVisionFatigue
Other measures (3)
Relapse Event, Annualized Relapse Rate
24 months
Disability progressionRelapsesConfirmed Relapse, Probability of First Relapse
24 months
RelapsesRelapse Event, Probability of First Relapse Event
24 months
Relapses
Who could take part
Relapsing MS · 18 to 50
Inclusion Criteria: * Diagnosis of relapsing remitting multiple sclerosis * At least one relapse in the last two years Exclusion Criteria: * Patients treated in the past with total lymphoid irradiation, monoclonal antibody, T cell vaccination, cladribine, bone marrow transplantation, azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin or Tysabri * Clinically significant diseases other than multiple sclerosis
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone injections in all subjects. The primary outcome measure is a reduction in relapses.
Papers
Results
Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial.Lancet Neurol · 2016
Results
Disability-Specific Atlases of Gray Matter Loss in Relapsing-Remitting Multiple Sclerosis.JAMA Neurol · 2016
Background
Sicotte NL, Liva SM, Klutch R, Pfeiffer P, Bouvier S, Odesa S, Wu TC, Voskuhl RR. Treatment of multiple sclerosis with the pregnancy hormone estriol. Ann Neurol. 2002 Oct;52(4):421-8. doi: 10.1002/ana.10301.Background
Soldan SS, Alvarez Retuerto AI, Sicotte NL, Voskuhl RR. Immune modulation in multiple sclerosis patients treated with the pregnancy hormone estriol. J Immunol. 2003 Dec 1;171(11):6267-74. doi: 10.4049/jimmunol.171.11.6267.Background
Morales LB, Loo KK, Liu HB, Peterson C, Tiwari-Woodruff S, Voskuhl RR. Treatment with an estrogen receptor alpha ligand is neuroprotective in experimental autoimmune encephalomyelitis. J Neurosci. 2006 Jun 21;26(25):6823-33. doi: 10.1523/JNEUROSCI.0453-06.2006.Background
Tiwari-Woodruff S, Morales LB, Lee R, Voskuhl RR. Differential neuroprotective and antiinflammatory effects of estrogen receptor (ER)alpha and ERbeta ligand treatment. Proc Natl Acad Sci U S A. 2007 Sep 11;104(37):14813-8. doi: 10.1073/pnas.0703783104. Epub 2007 Sep 4.Background
Sicotte NL, Giesser BS, Tandon V, Klutch R, Steiner B, Drain AE, Shattuck DW, Hull L, Wang HJ, Elashoff RM, Swerdloff RS, Voskuhl RR. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007 May;64(5):683-8. doi: 10.1001/archneur.64.5.683.Background
Gold SM, Sasidhar MV, Morales LB, Du S, Sicotte NL, Tiwari-Woodruff SK, Voskuhl RR. Estrogen treatment decreases matrix metalloproteinase (MMP)-9 in autoimmune demyelinating disease through estrogen receptor alpha (ERalpha). Lab Invest. 2009 Oct;89(10):1076-83. doi: 10.1038/labinvest.2009.79. Epub 2009 Aug 10.Background
Ziehn MO, Avedisian AA, Dervin SM, O'Dell TJ, Voskuhl RR. Estriol preserves synaptic transmission in the hippocampus during autoimmune demyelinating disease. Lab Invest. 2012 Aug;92(8):1234-45. doi: 10.1038/labinvest.2012.76. Epub 2012 Apr 23.Background
Spence RD, Hamby ME, Umeda E, Itoh N, Du S, Wisdom AJ, Cao Y, Bondar G, Lam J, Ao Y, Sandoval F, Suriany S, Sofroniew MV, Voskuhl RR. Neuroprotection mediated through estrogen receptor-alpha in astrocytes. Proc Natl Acad Sci U S A. 2011 May 24;108(21):8867-72. doi: 10.1073/pnas.1103833108. Epub 2011 May 9.
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History
Started
Mar 2007
Main results due
Jul 2014
Finished
Jul 2014
Results posted
Jun 2016
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