Multiple SclerosisPhase 4NCT01411514

Oral Prednisone Taper Versus Placebo for the Treatment of Acute Relapses in Multiple Sclerosis

A Phase 4 study testing Prednisone in people with Multiple Sclerosis, run by Claudio Gobbi at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: Prednisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteSwitzerland
Study dates: Aug 2011to Jan 2015
Phase: Phase 4
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

female or male
aged between 18 and 80 years;
with relapsing forms of multiple sclerosis diagnosed according to McDonald's criteria, including RR-MS and relapsing SP-MS, CIS, PP;
with EDSS score between 0 and 8;
experiencing an acute relapse with a documented clinical worsening of at least one point of the EDSS scale or a worsening of at least 2 points in one of the EDSS functional systems;
having agreed to have MRI and having already received at least one enhanced MRI before study procedures without major side effects;
having agreed to adhere to the study procedures;
having signed the written informed consent form.

Who cannot join

secondary progressive MS without superimposing relapses;
primary progressive MS without superimposed relapses;
patients suffering from any clinical condition contraindicated for steroid, in particular
Systemic fungal infection
Severe osteoporosis
Uncontrolled hypertension or congestive heart failure.

Show all 39Show fewer

Existing or previous history of severe affective disorders (especially previous steroid psychosis).
Diabetes mellitus
History of tuberculosis
Glaucoma
Previous corticosteroid-induced myopathy
Liver failure or cirrhosis
Renal insufficiency
Active epilepsy
Peptic ulceration
Fresh intestinal anastomoses
Predisposition to thrombophlebitis
Abscess or other pyogenic infections
Diverticulitis
Myasthenia gravis
Ocular herpes simplex
Hypothyroidism
Recent myocardial infarction
Kaposi's sarcoma;
any disease other than multiple sclerosis that would better explain the patient's signs and symptoms;
women of potential childbearing without active contraceptive methods;
pregnancy (urine pregnancy test at baseline visit) or breast feeding;
history of affective disorders;
history of attempted suicide or current suicidal ideas;
medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study;
inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study;
known hypersensitivity to prednisone or excipients of the study medications;
any contraindication for concomitant medications;
any contraindication for MRI or contrast administration;
a history of drug abuse in the 6 months prior to screening;
use of steroids during the previous 30 days (disease-modifying therapies for the treatment of MS are allowed);
treatment with drugs that might interfere with the evaluation of study drugs during the study protocol (see Section 4.2.2);
likelihood of requiring treatment during the study period with drugs not permitted by the study protocol;
participation in an other clinical trial within 30 days prior to entry in this study or current participation in another trial.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Osepdale Civico
Lugano, Canton Ticino, 6903

Other trials in Switzerland

About this study

Official title: Phase IV Study of Oral Prednisone Taper vs. Placebo Following Intravenous Steroids for the Treatment of Acute Relapses in Multiple Sclerosis Within the Ticino Cohort

The management of MS-patients requires treatment with immune-modifying or immune-suppressive agents to prevent new relapses and progression of disability. Several studies have evaluated the effect of steroid treatment on clinical recovery after an acute relapse. An important unanswered clinical question is, whether or not an oral tapering dose of corticosteroids offers any additional advantage over intravenous methylprednisolone alone in improving neurologic recovery as well as safety and tolerability after a relapse.

This study aims to compare the efficacy, tolerability and safety of tapering doses of oral prednisone and placebo after short-term high-dose i.v. methylprednisolone on the recovery from an acute relapse in patients with clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RR-MS) and primary (PP-MS) or secondary progressive multiple sclerosis (SP-MS) with superimposed relapses.

Patients will be treated during 25 days with de-escaling doses of prednisone or placebo.

The primary analysis will test whether placebo is equivalent to oral prednisone taper on the recovery status as measured by EDSS change from baseline to 3 months after baseline.

Read the detailed description

The purpose of this double-blind, randomised, placebo-controlled, prospective, parallel group, single centre study is to evaluate the effect of tapering oral doses of prednisone or placebo taken during 25 days following short-term high-dose i.v. methylprednisolone on the outcome of a relapse in patients with CIS; RR-MS, PP-MS or SP-MS with superimposed relapses. The primary objective is to assess and compare the recovery status in both patient groups 3 months after baseline by means of Expanded Disability Status Scale (EDSS). Secondary objectives are the assessments of clinical parameters at the end of oral treatment, 6, 9 months after baseline, of MRI markers, of mental and cognitive status, quality of life and fatigue at the end of oral treatment, 3 and 6 months after baseline in both patient groups.

After standard treatment of an acute clinical relapse with high dose, short term i.v. methyprednisolone patients will be randomised to one of the two treatment arms. Patients allocated to prednisone will be treated with tapering oral doses during 25 days. The initial dose of 60 mg will be reduced twice by 20 mg, than by 10 and 5 mg. Each dose regimen will be taken during 5±2 days. Patients randomised to placebo will receive placebo treatment during 25 days.

Conditions: Multiple Sclerosis
Being tested: Prednisone, Placebo
Keywords: Relapsing remittent multipse sclerosis, Secondary progressive multiple sclerosis, Clinically isolated syndrome, Primary progressive multiple sclerosis
Medical subject headings: Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive

What participants receive

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

PrednisoneDrug
Also called Prednison Axapharm
Tablets, 60 mg od p.o. for 5 days, followed by 40 mg o.d. p.o. for 5 days, 20 mg o.d. p.o. for 5 days, 10 mg o.d. p.o. for 5 days, 5 mg o.d. p.o. for 5 days
PlaceboDrug
Also called Placebo tablets
Placebo tablets. They will be administered during 25 days

Study groups in NCT01411514
Study group	Role	What they receive
Prednisone	Experimental	Not described Receives: Drug: Prednisone
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Expanded Disability Status Scale (EDSS)
The scores of the Expanded Disability Status Scale (EDSS) will be assessed at baseline, defined as start of oral treatment with prednisone or placebo (Day 1), and 3 months after baseline.
Measured: baseline, 3 months

Secondary outcomes (28)

Expanded Disability Status Scale (EDSS)
the scores of the Expanded Disability Status Scale (EDSS) will be assessed at baseline, at end of treatment, 6, and 9 months after baseline;
Measured: baseline, 25 days (end of treatment)
Multiple Sclerosis Functional Composite Score (MSFC)
the Multiple Sclerosis Functional Composite Score (MSFC) includes the Timed 25 foot-walk-test, the 9 Hole Peg test and Paced Auditorial Addition Test (PASAT)
Measured: baseline, 25 days (end of treatment)
Gd-enhancing lesions on T1-weighted images
the evolution of the number of Gd-enhancing lesions on T1-weighted images will be assessed
Measured: baseline, 25 days (end of treatment)
number of new T2-hyperintense lesions
the evolution of the number of new T2-hyperintense lesions will be assessed
Measured: baseline, 25 days (end of treatment)
mental status (MUSIC)
investigator administered questionnaire
Measured: baseline, 25 days (end of treatment)
Euroqol-5D (EQ-5D
patient reported quality of life
Measured: baseline, 25 days (end of treatment)
Functional Assessment Multiple Sclerosis (FAMS)
Patient reported outcome
Measured: at baseline, 25 days (end of treatment)
Beck Depression Inventory Second edition (BDI-II)
Investigator administered questionnaire
Measured: baseline, 25 days (end of treatment)
Fatigue Scale for Motor and Cognitive functions (FSMC)
Investigator administered questionnaire
Measured: baseline, 25 days (end of treatment)
Expanded Disability Status Scale (EDSS)
The scores of the Expanded Disability Status Scale (EDSS) will be assessed at baseline, defined as start of oral treatment with prednisone or placebo (Day 1), and 6 months after baseline.
Measured: baseline, 6 months
Expanded Disability Status Scale (EDSS)
The scores of the Expanded Disability Status Scale (EDSS) will be assessed at baseline, defined as start of oral treatment with prednisone or placebo (Day 1), and 9 months after baseline.
Measured: baseline, 9 months
Multiple Sclerosis Functional Composite Score (MSFC)
the Multiple Sclerosis Functional Composite Score (MSFC) includes the Timed 25 foot-walk-test, the 9 Hole Peg test and Paced Auditorial Addition Test (PASAT)
Measured: baseline, 3 months
Multiple Sclerosis Functional Composite Score (MSFC)
the Multiple Sclerosis Functional Composite Score (MSFC) includes the Timed 25 foot-walk-test, the 9 Hole Peg test and Paced Auditorial Addition Test (PASAT)
Measured: baseline, 6 months
Multiple Sclerosis Functional Composite Score (MSFC)
the Multiple Sclerosis Functional Composite Score (MSFC) includes the Timed 25 foot-walk-test, the 9 Hole Peg test and Paced Auditorial Addition Test (PASAT)
Measured: baseline, 9 months
Gd-enhancing lesions on T1-weighted images
the evolution of the number of Gd-enhancing lesions on T1-weighted images will be assessed
Measured: baseline, 3 months
Gd-enhancing lesions on T1-weighted images
the evolution of the number of Gd-enhancing lesions on T1-weighted images will be assessed
Measured: baseline, 6 months
number of new T2-hyperintense lesions
the evolution of the number of new T2-hyperintense lesions will be assessed
Measured: baseline, 3 months
number of new T2-hyperintense lesions
the evolution of the number of new T2-hyperintense lesions will be assessed
Measured: baseline, 6 months
mental status (MUSIC)
investigator administered questionnaire
Measured: baseline, 3 months
mental status (MUSIC)
investigator administered questionnaire
Measured: baseline, 6 months
Euroqol-5D (EQ-5D
patient reported quality of life
Measured: baseline, 3 months
Euroqol-5D (EQ-5D
patient reported quality of life
Measured: baseline, 6 months
Functional Assessment Multiple Sclerosis (FAMS)
Patient reported outcome
Measured: at baseline, 3 months
Functional Assessment Multiple Sclerosis (FAMS)
Patient reported outcome
Measured: at baseline, 6 months
Beck Depression Inventory Second edition (BDI-II)
Investigator administered questionnaire
Measured: baseline, 3 months
Beck Depression Inventory Second edition (BDI-II)
Investigator administered questionnaire
Measured: baseline, 6 months
Fatigue Scale for Motor and Cognitive functions (FSMC)
Investigator administered questionnaire
Measured: baseline, 3 months
Fatigue Scale for Motor and Cognitive functions (FSMC)
Investigator administered questionnaire
Measured: baseline, 6 months

Timeline

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

Aug 2011Jan 2015

First posted8 Aug 2011 (estimated)
Study startAug 2011
Primary completionJan 2015
Study completionJan 2015

Why it stopped: Difficulties to recruit patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01411514
Sponsor's protocol ID: EOC.NC.10.04
Status last verified: Dec 2015
First submitted: 26 May 2011
Last updated: 18 Dec 2015
Results posted: No
Data monitoring committee: No

Publications

Sellebjerg F, Barnes D, Filippini G, Midgard R, Montalban X, Rieckmann P, Selmaj K, Visser LH, Sorensen PS; EFNS Task Force on Treatment of Multiple Sclerosis Relapses. EFNS guideline on treatment of multiple sclerosis relapses: report of an EFNS task force on treatment of multiple sclerosis relapses. Eur J Neurol. 2005 Dec;12(12):939-46. doi: 10.1111/j.1468-1331.2005.01352.x.
PubMed 16324087
Burton JM, O'Connor PW, Hohol M, Beyene J. Oral versus intravenous steroids for treatment of relapses in multiple sclerosis. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006921. doi: 10.1002/14651858.CD006921.pub2.
PubMed 19588409
Martinelli V, Rocca MA, Annovazzi P, Pulizzi A, Rodegher M, Martinelli Boneschi F, Scotti R, Falini A, Sormani MP, Comi G, Filippi M. A short-term randomized MRI study of high-dose oral vs intravenous methylprednisolone in MS. Neurology. 2009 Dec 1;73(22):1842-8. doi: 10.1212/WNL.0b013e3181c3fd5b.
PubMed 19949030
Perumal JS, Caon C, Hreha S, Zabad R, Tselis A, Lisak R, Khan O. Oral prednisone taper following intravenous steroids fails to improve disability or recovery from relapses in multiple sclerosis. Eur J Neurol. 2008 Jul;15(7):677-80. doi: 10.1111/j.1468-1331.2008.02146.x. Epub 2008 May 6.
PubMed 18459972

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IV Study of Oral Prednisone Taper vs. Placebo Following Intravenous Steroids for the Treatment of Acute Relapses in Multiple Sclerosis Within the Ticino Cohort
ClinicalTrials.gov ID: NCT01411514
Acronym / sponsor ID: EOC.NC.10.04
Conditions: Multiple Sclerosis
Keywords: Relapsing remittent multipse sclerosis, Secondary progressive multiple sclerosis, Clinically isolated syndrome, Primary progressive multiple sclerosis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulties to recruit patients
Enrolment: 27 participants (actual)
Lead sponsor: Claudio GobbiOther government
Collaborators: Ente Ospedaliero Cantonale, Ticino, Switzerland
Study start: Aug 2011
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 8 Aug 2011 (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.

Patients will be treated during 25 days with de-escaling doses of prednisone or placebo.

The primary analysis will test whether placebo is equivalent to oral prednisone taper on the recovery status as measured by EDSS change from baseline to 3 months after baseline.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Prednisone	Experimental	Drug: Prednisone
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

female or male
aged between 18 and 80 years;
with relapsing forms of multiple sclerosis diagnosed according to McDonald's criteria, including RR-MS and relapsing SP-MS, CIS, PP;
with EDSS score between 0 and 8;
experiencing an acute relapse with a documented clinical worsening of at least one point of the EDSS scale or a worsening of at least 2 points in one of the EDSS functional systems;

Key exclusion criteria (39 listed)

secondary progressive MS without superimposing relapses;
primary progressive MS without superimposed relapses;
patients suffering from any clinical condition contraindicated for steroid, in particular
any disease other than multiple sclerosis that would better explain the patient's signs and symptoms;
women of potential childbearing without active contraceptive methods;

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
PrednisoneAlso: Prednison AxapharmTablets, 60 mg od p.o. for 5 days, followed by 40 mg o.d. p.o. for 5 days, 20 mg o.d. p.o. for 5 days, 10 mg o.d. p.o. for 5 days, 5 mg o.d. p.o. for 5 days	Drug	Prednisone
PlaceboAlso: Placebo tabletsPlacebo tablets. They will be administered during 25 days	Drug	Placebo

Primary outcome

Expanded Disability Status Scale (EDSS)
Time frame: baseline, 3 months
The scores of the Expanded Disability Status Scale (EDSS) will be assessed at baseline, defined as start of oral treatment with prednisone or placebo (Day 1), and 3 months after baseline.

28 secondary outcomes

Expanded Disability Status Scale (EDSS)
Time frame: baseline, 25 days (end of treatment)
Multiple Sclerosis Functional Composite Score (MSFC)
Time frame: baseline, 25 days (end of treatment)
Gd-enhancing lesions on T1-weighted images
Time frame: baseline, 25 days (end of treatment)
number of new T2-hyperintense lesions
Time frame: baseline, 25 days (end of treatment)
mental status (MUSIC)
Time frame: baseline, 25 days (end of treatment)
Euroqol-5D (EQ-5D
Time frame: baseline, 25 days (end of treatment)
Functional Assessment Multiple Sclerosis (FAMS)
Time frame: at baseline, 25 days (end of treatment)
Beck Depression Inventory Second edition (BDI-II)
Time frame: baseline, 25 days (end of treatment)
Fatigue Scale for Motor and Cognitive functions (FSMC)
Time frame: baseline, 25 days (end of treatment)
Expanded Disability Status Scale (EDSS)
Time frame: baseline, 6 months
Expanded Disability Status Scale (EDSS)
Time frame: baseline, 9 months
Multiple Sclerosis Functional Composite Score (MSFC)
Time frame: baseline, 3 months
Multiple Sclerosis Functional Composite Score (MSFC)
Time frame: baseline, 6 months
Multiple Sclerosis Functional Composite Score (MSFC)
Time frame: baseline, 9 months
Gd-enhancing lesions on T1-weighted images
Time frame: baseline, 3 months
Gd-enhancing lesions on T1-weighted images
Time frame: baseline, 6 months
number of new T2-hyperintense lesions
Time frame: baseline, 3 months
number of new T2-hyperintense lesions
Time frame: baseline, 6 months
mental status (MUSIC)
Time frame: baseline, 3 months
mental status (MUSIC)
Time frame: baseline, 6 months
Euroqol-5D (EQ-5D
Time frame: baseline, 3 months
Euroqol-5D (EQ-5D
Time frame: baseline, 6 months
Functional Assessment Multiple Sclerosis (FAMS)
Time frame: at baseline, 3 months
Functional Assessment Multiple Sclerosis (FAMS)
Time frame: at baseline, 6 months
Beck Depression Inventory Second edition (BDI-II)
Time frame: baseline, 3 months
Beck Depression Inventory Second edition (BDI-II)
Time frame: baseline, 6 months
Fatigue Scale for Motor and Cognitive functions (FSMC)
Time frame: baseline, 3 months
Fatigue Scale for Motor and Cognitive functions (FSMC)
Time frame: baseline, 6 months

Results and safety

The study was stopped early (reason given: Difficulties to recruit patients). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
Background: PubMed 16324087Sellebjerg F, Barnes D, Filippini G, Midgard R, Montalban X, Rieckmann P, Selmaj K, Visser LH, Sorensen PS; EFNS Task Force on Treatment of Multiple Sclerosis Relapses. EFNS guideline on treatment of multiple sclerosis relapses: report of an EFNS task force on treatment of multiple sclerosis relapses. Eur J Neurol. 2005 Dec;12(12):939-46. doi: 10.1111/j.1468-1331.2005.01352.x.
Background: PubMed 19588409Burton JM, O'Connor PW, Hohol M, Beyene J. Oral versus intravenous steroids for treatment of relapses in multiple sclerosis. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006921. doi: 10.1002/14651858.CD006921.pub2.
Background: PubMed 19949030Martinelli V, Rocca MA, Annovazzi P, Pulizzi A, Rodegher M, Martinelli Boneschi F, Scotti R, Falini A, Sormani MP, Comi G, Filippi M. A short-term randomized MRI study of high-dose oral vs intravenous methylprednisolone in MS. Neurology. 2009 Dec 1;73(22):1842-8. doi: 10.1212/WNL.0b013e3181c3fd5b.
Background: PubMed 18459972Perumal JS, Caon C, Hreha S, Zabad R, Tselis A, Lisak R, Khan O. Oral prednisone taper following intravenous steroids fails to improve disability or recovery from relapses in multiple sclerosis. Eur J Neurol. 2008 Jul;15(7):677-80. doi: 10.1111/j.1468-1331.2008.02146.x. Epub 2008 May 6.
Related information to the institutionLink provided by the sponsor.
Non profit organisazion that supports multiple sclerosis patientsLink provided by the sponsor.

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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.

Claudio Gobbi, MD principal investigator

Neurocenter of Southern Switzerland

Claudio Gobbi, MD study director

Neurocenter of Southern Switzerland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prednisone in people with Multiple Sclerosis, run by Claudio Gobbi at 1 site in Switzerland.

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 8 inclusion and 39 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: stopped early, as of the sponsor's last update on 18 Dec 2015. 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 Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was stopped early (reason given: Difficulties to recruit patients). 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?

Expanded Disability Status Scale (EDSS) (time frame: baseline, 3 months). 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 NCT01411514, 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 18 Dec 2015.