Multiple SclerosisPhase 2NCT00151801
Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients
A Phase 2 study testing estroprogestins and interferon-beta 1a in people with Multiple Sclerosis, run by S. Andrea Hospital at 1 site in Italy.
Trial summary
Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis. The role of oral estroprogestins in the pathogenesis and in the clinical course of the disease is actually unknown. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- estroprogestins and interferon-beta 1a
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- May 2002to Dec 2008
- Phase
- Phase 2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients
- Clinically definite relapsing-remitting MS according to the McDonald criteria
- Age between 18-40 y.o.
- EDSS from 0 to 4.0, inclusive
Who cannot join
- History of migraine or thromboembolic events
- Reproductive system disorders
- Pregnancy or suspension of pregnancy within 12 months prior to randomisation
- Prior use of estroprogestins within the last 3 months prior to randomisation
- Prior use of immunosuppressive drugs within the last 12 months prior to randomisation
- Prior use of immunomodulating drugs within the last 6 months prior to randomisation
- Prior use of corticosteroids within the last 3 months prior to randomisation
- Have clinical relapse 30 days prior to randomisation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Neurology - University of Rome La Sapienza
Rome, Rome, 00100
Carlo Pozzilli, MD, +39-06-49914716, carlo.pozzilli@uniroma1.it
Fabiana Marinelli, MD, +39-338-2955443, fabiana.marinelli@uniroma1.it
About this study
Official title: Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis.
The role of oral estroprogestins in the pathogenesis and in the clinical course of the disease is actually unknown.
The aim of the study is to investigate safety and tolerability of association of estroprogestins in two different doses with interferon-beta 1a in patients with relapsing-remitting multiple sclerosis.
Read the detailed description
Phase 2, randomised, single blind, three arms study.
Follow-up of 24 months.
The study will include relapsing-remitting multiple sclerosis female patients.
Patients will be equally randomised into three groups: 1) patients treated with IFN-beta 1a (44 mcg for three times a week), 2) patients treated with IFN-beta 1a and lower-dose estroprogestins (desogestrel 150 mcg, etinilestradiol 20 mcg), 3) patients treated with IFN-beta 1a and higher-dose estroprogestins (desogestrel 25 mcg, etinilestradiol 40 mcg).
Safety and tolerability of the treatment will be evaluated using neurological examination and MRI analysis.
A complete neurological examination (with EDSS) will be performed at month 0, 6, 12, 18 and 24.
MRI examination will be assessed at baseline and at month 12 and 24. In the same day of MRI examination we'll collect blood samples for hormonal analysis (we'll measure sex hormones in the follicular and in the luteal phase of a single menstrual cycle).
During the follow-up patients will be evaluated also with: MS-Functional Composite at month 0, 6, 12, 18, 24; neuropsychological evaluation at month 0, 12, 24; Fatigue Severity Scale at month 0, 12, 24; Hamilton Depression Scale at month 0, 12, 24; Quality of Life scale (MSQOL54) at month 0, 12, 24.
- Conditions
- Multiple Sclerosis
- Being tested
- estroprogestins, interferon-beta 1a
- Keywords
- multiple sclerosis, estroprogestins, interferon-beta, sex hormones, MRI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estroprogestinsDrug
interferon-beta 1aDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment at 6, 12, 18 and 24 months, including adverse events, physical examination and laboratory parameters
Relapse rate at 6, 12, 18 and 24 months,
EDSS progression at 12 and 24 months,
MS functional composite score at 12 and 24 months,
Secondary outcomes (7)
Number and volume of new gad-enhancing lesions at 12 and 24 months
Number of new T1 and T2 lesions at 12 and 24 months
Brain volume changes at 12 and 24 months
Neuropsychological examination at 0, 12, 24 months
Hamilton scale for depression score at 0, 12, 24 months
MS Quality of Life scale score(MSQOL54)at 0, 12, 24 months
Fatigue Severity Scale score at 0, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startMay 2002
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- S. Andrea Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Valentina Tomassini, MD, Study chair, Department of Neurological Science University of Rome "La Sapienza"Fabiana Marinelli, MD, Principal investigator, Department of Neurological Science, University of Rome "La Sapienza"Carlo Pozzilli, MD, Study director, Department of Neurological Science, University of Rome "La Sapienza"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151801
- Sponsor's protocol ID
- NEU - PIL - 03
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 9 Sep 2005
- Results posted
- No
Publications
Hawkins SA, McDonnell GV. Benign multiple sclerosis? Clinical course, long term follow up, and assessment of prognostic factors. J Neurol Neurosurg Psychiatry. 1999 Aug;67(2):148-52. doi: 10.1136/jnnp.67.2.148.
PubMed 10406979Zorgdrager A, De Keyser J. Menstrually related worsening of symptoms in multiple sclerosis. J Neurol Sci. 1997 Jul;149(1):95-7. doi: 10.1016/s0022-510x(97)05396-3.
PubMed 9168172Bansil S, Lee HJ, Jindal S, Holtz CR, Cook SD. Correlation between sex hormones and magnetic resonance imaging lesions in multiple sclerosis. Acta Neurol Scand. 1999 Feb;99(2):91-4. doi: 10.1111/j.1600-0404.1999.tb00663.x.
PubMed 10071166Kim S, Liva SM, Dalal MA, Verity MA, Voskuhl RR. Estriol ameliorates autoimmune demyelinating disease: implications for multiple sclerosis. Neurology. 1999 Apr 12;52(6):1230-8. doi: 10.1212/wnl.52.6.1230.
PubMed 10214749Hernan MA, Hohol MJ, Olek MJ, Spiegelman D, Ascherio A. Oral contraceptives and the incidence of multiple sclerosis. Neurology. 2000 Sep 26;55(6):848-54. doi: 10.1212/wnl.55.6.848.
PubMed 10994007Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998 Nov 7;352(9139):1498-504.
PubMed 9820297De Cicco Nardone F, Rossiello F, Iacopino F, Benedetto MT, Cinque B, Dell'Acqua S, Sica G. Effects of interferon-beta on steroid receptors, prostaglandins and enzymatic activities in human endometrial cancer. Anticancer Res. 1996 Jan-Feb;16(1):161-9.
PubMed 8615603Pozzilli C, Tomassini V, Marinelli F, Paolillo A, Gasperini C, Bastianello S. 'Gender gap' in multiple sclerosis: magnetic resonance imaging evidence. Eur J Neurol. 2003 Jan;10(1):95-7. doi: 10.1046/j.1468-1331.2003.00519.x.
PubMed 12535003De Giglio L, Marinelli F, Barletta VT, Pagano VA, De Angelis F, Fanelli F, Petsas N, Pantano P, Tomassini V, Pozzilli C. Effect on Cognition of Estroprogestins Combined with Interferon Beta in Multiple Sclerosis: Analysis of Secondary Outcomes from a Randomised Controlled Trial. CNS Drugs. 2017 Feb;31(2):161-168. doi: 10.1007/s40263-016-0401-0.
PubMed 27995531
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00151801
- Acronym / sponsor ID
- NEU - PIL - 03
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, estroprogestins, interferon-beta, sex hormones, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- S. Andrea HospitalUniversity, hospital or other
- Study start
- May 2002
- Study completion
- Dec 2008
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis.
The role of oral estroprogestins in the pathogenesis and in the clinical course of the disease is actually unknown.
The aim of the study is to investigate safety and tolerability of association of estroprogestins in two different doses with interferon-beta 1a in patients with relapsing-remitting multiple sclerosis.
Detailed description
Phase 2, randomised, single blind, three arms study.
Follow-up of 24 months.
The study will include relapsing-remitting multiple sclerosis female patients.
Patients will be equally randomised into three groups: 1) patients treated with IFN-beta 1a (44 mcg for three times a week), 2) patients treated with IFN-beta 1a and lower-dose estroprogestins (desogestrel 150 mcg, etinilestradiol 20 mcg), 3) patients treated with IFN-beta 1a and higher-dose estroprogestins (desogestrel 25 mcg, etinilestradiol 40 mcg).
Safety and tolerability of the treatment will be evaluated using neurological examination and MRI analysis.
A complete neurological examination (with EDSS) will be performed at month 0, 6, 12, 18 and 24.
MRI examination will be assessed at baseline and at month 12 and 24. In the same day of MRI examination we'll collect blood samples for hormonal analysis (we'll measure sex hormones in the follicular and in the luteal phase of a single menstrual cycle).
During the follow-up patients will be evaluated also with: MS-Functional Composite at month 0, 6, 12, 18, 24; neuropsychological evaluation at month 0, 12, 24; Fatigue Severity Scale at month 0, 12, 24; Hamilton Depression Scale at month 0, 12, 24; Quality of Life scale (MSQOL54) at month 0, 12, 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients
- Clinically definite relapsing-remitting MS according to the McDonald criteria
- Age between 18-40 y.o.
- EDSS from 0 to 4.0, inclusive
Key exclusion criteria (8 listed)
- History of migraine or thromboembolic events
- Reproductive system disorders
- Pregnancy or suspension of pregnancy within 12 months prior to randomisation
- Prior use of estroprogestins within the last 3 months prior to randomisation
- Prior use of immunosuppressive drugs within the last 12 months prior to randomisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estroprogestins | Drug | – |
| interferon-beta 1a | Drug | – |
Primary outcome
Safety assessment at 6, 12, 18 and 24 months, including adverse events, physical examination and laboratory parameters
Relapse rate at 6, 12, 18 and 24 months,
EDSS progression at 12 and 24 months,
MS functional composite score at 12 and 24 months,
7 secondary outcomes
Number and volume of new gad-enhancing lesions at 12 and 24 months
Number of new T1 and T2 lesions at 12 and 24 months
Brain volume changes at 12 and 24 months
Neuropsychological examination at 0, 12, 24 months
Hamilton scale for depression score at 0, 12, 24 months
MS Quality of Life scale score(MSQOL54)at 0, 12, 24 months
Fatigue Severity Scale score at 0, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2005.
- Background: PubMed 10406979Hawkins SA, McDonnell GV. Benign multiple sclerosis? Clinical course, long term follow up, and assessment of prognostic factors. J Neurol Neurosurg Psychiatry. 1999 Aug;67(2):148-52. doi: 10.1136/jnnp.67.2.148.
- Background: PubMed 9168172Zorgdrager A, De Keyser J. Menstrually related worsening of symptoms in multiple sclerosis. J Neurol Sci. 1997 Jul;149(1):95-7. doi: 10.1016/s0022-510x(97)05396-3.
- Background: PubMed 10071166Bansil S, Lee HJ, Jindal S, Holtz CR, Cook SD. Correlation between sex hormones and magnetic resonance imaging lesions in multiple sclerosis. Acta Neurol Scand. 1999 Feb;99(2):91-4. doi: 10.1111/j.1600-0404.1999.tb00663.x.
- Background: PubMed 10214749Kim S, Liva SM, Dalal MA, Verity MA, Voskuhl RR. Estriol ameliorates autoimmune demyelinating disease: implications for multiple sclerosis. Neurology. 1999 Apr 12;52(6):1230-8. doi: 10.1212/wnl.52.6.1230.
- Background: PubMed 10994007Hernan MA, Hohol MJ, Olek MJ, Spiegelman D, Ascherio A. Oral contraceptives and the incidence of multiple sclerosis. Neurology. 2000 Sep 26;55(6):848-54. doi: 10.1212/wnl.55.6.848.
- Background: PubMed 9820297Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998 Nov 7;352(9139):1498-504.
- Background: PubMed 8615603De Cicco Nardone F, Rossiello F, Iacopino F, Benedetto MT, Cinque B, Dell'Acqua S, Sica G. Effects of interferon-beta on steroid receptors, prostaglandins and enzymatic activities in human endometrial cancer. Anticancer Res. 1996 Jan-Feb;16(1):161-9.
- Background: PubMed 12535003Pozzilli C, Tomassini V, Marinelli F, Paolillo A, Gasperini C, Bastianello S. 'Gender gap' in multiple sclerosis: magnetic resonance imaging evidence. Eur J Neurol. 2003 Jan;10(1):95-7. doi: 10.1046/j.1468-1331.2003.00519.x.
- Derived from this study: PubMed 27995531De Giglio L, Marinelli F, Barletta VT, Pagano VA, De Angelis F, Fanelli F, Petsas N, Pantano P, Tomassini V, Pozzilli C. Effect on Cognition of Estroprogestins Combined with Interferon Beta in Multiple Sclerosis: Analysis of Secondary Outcomes from a Randomised Controlled Trial. CNS Drugs. 2017 Feb;31(2):161-168. doi: 10.1007/s40263-016-0401-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Tomassini, MD study chair
Department of Neurological Science University of Rome "La Sapienza"
Fabiana Marinelli, MD principal investigator
Department of Neurological Science, University of Rome "La Sapienza"
Carlo Pozzilli, MD study director
Department of Neurological Science, University of Rome "La Sapienza"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing estroprogestins and interferon-beta 1a in people with Multiple Sclerosis, run by S. Andrea Hospital at 1 site in Italy.
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 8 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 9 Sep 2005. 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 Italy. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Carlo Pozzilli, MD (+39-06-49914716, carlo.pozzilli@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment at 6, 12, 18 and 24 months, including adverse events, physical examination and laboratory parameters. The study lists 4 primary outcomes in all. 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 NCT00151801, which also lists 9 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 9 Sep 2005.