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Multiple SclerosisPhase 3NCT00127075

POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis

A Phase 3 study testing nomegestrol acetate and estradiol in people with Multiple Sclerosis, run by Hospices Civils de Lyon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their childbearing years. It is an autoimmune disease of the central nervous system (CNS), which results in a chronic focal inflammatory response with subsequent demyelination and axonal loss. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Multiple Sclerosis
What is being tested?
nomegestrol acetate and estradiol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteFrance
Study dates
Jun 2005to Apr 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • MS according to MacDonald criteria (including clinically isolated syndromes fulfilling magnetic resonance imaging [MRI] criteria for MS diagnosis)
  • Relapsing-remitting or secondary progressive MS
  • Expanded disability status scale (EDSS) ≤ 6.0
  • Pregnancy ≤ 36 weeks of amenorrhea

Who cannot join

  • Age < 18 years
  • Clinical isolated syndrome not fulfilling MacDonald criteria for MS
  • Primary progressive MS
  • Possible MS or no MS according to MacDonald criteria
  • Ongoing or previous myocardial infarction, stroke or venous thromboembolism
  • Ongoing or previous breast cancer, or cancer of the uterus
Show all 14Show fewer
  • Severe liver disorder
  • Undiagnosed genital bleeding
  • Hypersensitivity to one of the study treatments
  • Desire for lactation
  • Desire for an MS disease-modifying treatment in the 24 weeks after delivery
  • Women participating in another trial with a drug
  • Refusal of non-hormonal contraception in the 12 weeks following delivery
  • Consent form not signed

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Pierre Wertheimer

    Bron, 69677

Other trials in France

About this study

Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their childbearing years. It is an autoimmune disease of the central nervous system (CNS), which results in a chronic focal inflammatory response with subsequent demyelination and axonal loss. Recent prospective studies reported a significant decline by two-thirds in the rate of relapses during the third trimester of pregnancy and a significant increase by two-thirds during the first three months post-partum by comparison to the relapse rate observed during the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the relapse rate occur at a time when the impregnation of many substances (among which, sexual steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels, immediately following delivery.

It may be hypothesized that sexual steroids could exert beneficial effects through a modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They may also play a direct role in the remyelination of central nervous system lesions, as they do in the peripheral nervous system. The POPART'MUS study is a European, multicentre, randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS relapses related to the post-partum condition, by administering high doses of progestin (nomegestrol acetate), in combination with endometrial protective doses of estradiol. Treatment will be given immediately after delivery and continuously during the first three months post-partum. Assuming the results of the trial to be positive, this new treatment could be considered in the relapsing-remitting phase of the disease in women afar from pregnancy and post-partum.

Being tested
nomegestrol acetate, estradiol, placebo
Keywords
Multiple sclerosis. Relapses. Post partum. Pregnancy. Delivery. Hormones. Progesterone. Estradiol. Clinical trial. Prevention.
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nomegestrol acetateDrug

    10 mg/day

  • estradiolDrug

    75 mcg, once a week

  • placeboDrug

    matching placebo treatments

Study groups in NCT00127075
Study groupRoleWhat they receive
NOMA + estradiolExperimentalOral NOMA (LUTENYL® 10 mg/day) combined with transdermal Estradiol (DERMESTRIL SEPTEM® 75 mcg, once a week),
Receives: Drug: nomegestrol acetate; Drug: estradiol
placeboPlacebo comparatorMatching placebo treatments
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the rate of relapses during the first 12 weeks after delivery, between the treated and placebo groups

    Measured: 12 weeks

Secondary outcomes (3)

  1. Percentage of patients who remain relapse-free during the 12-week period after delivery

    Measured: 12 weeks

  2. Rate of relapses, percentage of patients who remain relapse-free during the 24-week period after delivery

    Measured: 24 weeks

  3. Rate of relapses, percentage of patients who remain relapse-free during the 12- to 24-week period after delivery

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionApr 2012 (estimated)
  4. Study completionApr 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00127075
Sponsor's protocol ID
2004.363
Status last verified
Dec 2011
First submitted
4 Aug 2005
Last updated
30 Dec 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Confavreux C, Hutchinson M, Hours MM, Cortinovis-Tourniaire P, Moreau T. Rate of pregnancy-related relapse in multiple sclerosis. Pregnancy in Multiple Sclerosis Group. N Engl J Med. 1998 Jul 30;339(5):285-91. doi: 10.1056/NEJM199807303390501.

    PubMed 9682040

  • Confavreux C, Hutchinson M, Hours M, Cortinovis-Tourniaire P, Grimaud J, Moreau T. [Multiple sclerosis and pregnancy: clinical issues]. Rev Neurol (Paris). 1999 Mar;155(3):186-91. French.

    PubMed 10339787

  • Vukusic S, Hutchinson M, Hours M, Moreau T, Cortinovis-Tourniaire P, Adeleine P, Confavreux C; Pregnancy In Multiple Sclerosis Group. Pregnancy and multiple sclerosis (the PRIMS study): clinical predictors of post-partum relapse. Brain. 2004 Jun;127(Pt 6):1353-60. doi: 10.1093/brain/awh152. Epub 2004 May 6.

    PubMed 15130950

  • Vukusic S, Ionescu I, El-Etr M, Schumacher M, Baulieu EE, Cornu C, Confavreux C; Prevention of Post-Partum Relapses with Progestin and Estradiol in Multiple Sclerosis Study Group. The Prevention of Post-Partum Relapses with Progestin and Estradiol in Multiple Sclerosis (POPART'MUS) trial: rationale, objectives and state of advancement. J Neurol Sci. 2009 Nov 15;286(1-2):114-8. doi: 10.1016/j.jns.2009.08.056. Epub 2009 Sep 15.

    PubMed 19758607

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nomegestrol acetate and estradiol in people with Multiple Sclerosis, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the rate of relapses during the first 12 weeks after delivery, between the treated and placebo groups (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00127075, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2011.

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