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Multiple Sclerosis, Chronic ProgressivePhase 3PROMESSNCT00241254

Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis

A Phase 3 study testing Cyclophosphamide (drug) and Methylprednisolone (drug) in people with Multiple Sclerosis, Chronic Progressive, run by University Hospital, Bordeaux at 26 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Preliminary not-controlled clinical studies of the efficacy of monthly intravenous cyclophosphamide administration in secondary progressive multiple sclerosis reported encouraging results, but no randomized controlled trial has been conducted so far. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis, Chronic Progressive
What is being tested?
Cyclophosphamide (drug) and Methylprednisolone (drug)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
26 sitesFrance
Study dates
Dec 2005to Mar 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Multiple sclerosis (MS) subjects (Mc Donald et al criteria),
  • Aged 18 to 65
  • Diagnosis of secondary progressive MS ( Lublin and Reingold criteria)
  • Progressive deterioration phase of at least 6 months and less than 4 years.
  • Reduction of walking capacity and increase EDSS not ascribed to consequence of relapses (at least 0.5 point) in the last 12 months
  • EDSS between 4.0 and 6.5 included
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  • Female participating must use contraceptives while on study drug
  • Written informed consent
  • Patient protected by French social security system

Who cannot join

  • Others diseases interfering with MS or treatment
  • Recent history (within the previous 2 years) of drug or alcohol abuse.
  • Patients with psychiatric illnesses who are unable to provide written, informed consent prior to any testing under this protocol
  • Hemorrhagic cystitis
  • Pregnant or lactating women
  • Known allergy at cyclophosphamide, corticoids and in particular methylprednisolone
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  • Persistent infectious diseases
  • Patients with bladder permanent catheterization
  • Known history of cardiac arrhythmia after methylprednisolone intravenous treatment
  • Abnormal screening/baseline blood tests exceeding any of the limits defined below : Hb < 9g/dl or Total white blood cell count less than 3 000/mm3 or lymphocytes count less than 900/ mm3 or Platelet count less than 125 000/mm3
  • Gastric or duodenal ulcer in evolution
  • Gut diverticulosis
  • Diabetes mellitus
  • Known history of active hepatitis (ASAT >3 X ULN)
  • Known history of renal failure (creatinine level > 180 µmol/L)
  • Psychosis
  • Current or past (< 3 months) participation in another drug trial
  • Prior use of cyclophosphamide, lymphoid irradiation, monoclonal antibodies anti CD4 or anti CD52 or anti-VLA-4 therapies, cladribine ou cyclosporine A
  • Other clinical types of MS : Secondary progressive phase evolving for more than 4 years ; Remittent type of MS without progression between relapses ; Primary progressive type of MS
  • Use of interferon beta, methotrexate or imurel in the month prior to study.
  • Treatment with intravenous monthly corticoids in the year prior to study.
  • Treatment with corticoids (3 to 5 days) in the 2 month prior to study.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

France26 sites

  • CH de la Cote Basque

    Bayonne, 64109

  • CHU Besançon

    Besançon, 25030

  • Hôpital Pellegrin, Département de neurologie

    Bordeaux, 33076

  • CHU Caen

    Caen, 14033

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003

  • AP HP Henri Mondor

    Créteil, 94010

  • CHU Dijon

    Dijon, 21033

  • CHU Lille Hôpital Salengro

    Lille, 59037

  • CHU Limoges

    Limoges, 87042

  • GHICL Hôpital St. Philibert

    Lomme, 59462

  • (CHU Lyon) Hôpital neurologique

    Lyon, 69394

  • Hôpital La Timone

    Marseille, 13385

  • (CHR Metz-Thionville) Hôpital Notre Dame de Bon Secours

    Metz, 57038

  • (CHU Montpellier), Hôpital de Gui de Chauliac

    Montpellier, 34295

  • CHU Nancy Hôpital central

    Nancy, 54035

  • Hôpital Guillaume et René Laënnec

    Nantes, 44093

  • CHU Nice Hôpital Pasteur

    Nice, 06002

  • (CHU Nîmes) Hôpital Caremeau

    Nîmes, 30029

  • Fondation Rothschild

    Paris, 75019

  • (AP HP) Hôpital Tenon

    Paris, 75970

  • Centre Hospitalier de Pau

    Pau, 64046

  • CHU de POISSY

    Poissy, 78300

  • (CHU Reims) Hôpital Robert Debré

    Reims, 51092

  • CHU Ponchaillou

    Rennes, 35033

  • CH d'Angoulême Girac

    Saint-Michel, 16470

  • (CHRU Starsbourg) Hôpital civil

    Strasbourg, 67091

Other trials in France

About this study

Official title: A Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study

Preliminary not-controlled clinical studies of the efficacy of monthly intravenous cyclophosphamide administration in secondary progressive multiple sclerosis reported encouraging results, but no randomized controlled trial has been conducted so far. The primary objective of this trial is to evaluate the efficacy of IV cyclophosphamide as compared to IV methylprednisolone administered every 4 weeks during 1 year and every 8 weeks during 1 year, on the delay to confirmed disability deterioration as assessed by the Expanded Disability Status Scale (EDSS) in patients with secondary progressive multiple sclerosis. The secondary objectives are to evaluate safety, tolerability and efficacy at 2 years on the Multiple Sclerosis Functional Composite (MSFC), the percentage of patients with disability deterioration (EDSS) and the number of relapses. An intention-to-treat statistical analysis will be carried out.

Read the detailed description

Background

Preliminary not-controlled clinical studies of the efficacy of monthly intravenous cyclophosphamide administration in secondary progressive multiple sclerosis reported encouraging results, but no randomized controlled trial has been conducted so far. A slight efficacy of Methylprednisolone has been reported in this indication.

Objectives

The primary objective is to evaluate the efficacy of IV cyclophosphamide on the prevention of disability deterioration in patients with secondary progressive multiple sclerosis.

The secondary objectives are to evaluate safety, tolerability and efficacy of IV cyclophosphamide on the Multiple Sclerosis Functional Composite (MSFC) and the number of relapses.

Study design

Randomized double-blind two-arm controlled trial.

Intervention

Experimental group : IV cyclophosphamide infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.

Control group : IV methylprednisolone infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.

Outcomes

Primary outcome : delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score) evaluated every 4 weeks for one year, then every 8 weeks for one year.

Secondary outcomes : proportion of patients with disability deterioration (EDSS: 0.5 or 1 point increase, depending on baseline score), Multiple Sclerosis Functional Composite (MSFC) and the Z scores of MSFC three components, number of MS relapses, proportion of patients with adverse events and delay of occurrence of adverse events, quality of life questionnaires.

  • Quality of life questionnaires
  • Disability self-assessment questionnaires Main time of assessment : 2 years.

Sample size

360 patients

Statistical analysis

Intention-to-treat analysis.

Being tested
Cyclophosphamide (drug), Methylprednisolone (drug)
Keywords
Multiple Sclerosis, Chronic Progressive, Cyclophosphamide, Methylprednisolone, Randomized Controlled Trials, Double-Blind Study
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

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

  • Cyclophosphamide (drug)Drug

    IV cyclophosphamide infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.

  • Methylprednisolone (drug)Drug

    Control group : IV methylprednisolone infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.

Study groups in NCT00241254
Study groupRoleWhat they receive
1ExperimentalCyclophosphamide
Receives: Drug: Cyclophosphamide (drug)
2Active comparatorMethylprednisolone
Receives: Drug: Methylprednisolone (drug)

What is being measured

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

  1. Delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score)

    Measured: every 4 weeks for one year, then every 8 weeks for one year

Secondary outcomes (6)

  1. Proportion of patients with disability deterioration (EDSS: 0.5 or 1 point increase, depending on baseline score)

    Measured: every month during one year then every two months during the 2nd year

  2. Multiple Sclerosis Functional Composite (MSFC) and the Z scores of MSFC three components

    Measured: Visit number 1, 2, 13(at one year),19 (at two years) and 20 (last visit)

  3. Number of MS relapses

    Measured: all along the follow up period

  4. Proportion of patients with adverse events and delay of occurrence of adverse events

    Measured: all along the follow up period

  5. Quality of life questionnaires

    Measured: visit 2, 13(at one year) and 19 (at two years)

  6. Disability self-assessment questionnaires

    Measured: visite 2, 13 et 19

Timeline

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

  1. First posted18 Oct 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionMar 2010
  4. Study completionMar 2012

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
Double blind
Who is masked
Participant, Investigator
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00241254
Sponsor's protocol ID
9408-04
Other IDs
2004-005
Acronym
PROMESS
Status last verified
Mar 2012
First submitted
17 Oct 2005
Last updated
15 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Brochet B, Deloire MS, Perez P, Loock T, Baschet L, Debouverie M, Pittion S, Ouallet JC, Clavelou P, de Seze J, Collongues N, Vermersch P, Zephir H, Castelnovo G, Labauge P, Lebrun C, Cohen M, Ruet A; PROMESS study investigators. Double-Blind Controlled Randomized Trial of Cyclophosphamide versus Methylprednisolone in Secondary Progressive Multiple Sclerosis. PLoS One. 2017 Jan 3;12(1):e0168834. doi: 10.1371/journal.pone.0168834. eCollection 2017.

    PubMed 28045953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide (drug) and Methylprednisolone (drug) in people with Multiple Sclerosis, Chronic Progressive, run by University Hospital, Bordeaux at 26 sites 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 9 inclusion and 22 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: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score) (time frame: every 4 weeks for one year, then every 8 weeks for one year). 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 NCT00241254, which also lists 1 linked publication.

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 15 Mar 2012.

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