Multiple SclerosisNCT00764413
Chronotherapy in Acute Multiple Sclerosis (MS) Attack
A study testing methylprednisolone and Sodium chlorid in people with Multiple Sclerosis, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
The Immunological system is showing a diurnal rhythmicity. The Mediators that enhances inflammation are at highest level during the night. At the same time the endogenous production of cortisol is at its lowest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- methylprednisolone and Sodium chlorid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2009to Jul 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsing remitting MS
- EDSS-score before the actual attack < 6.0
- Acute MS-attack with indication for treatment with steroids
- Symptoms >24 hours < 4 weeks
- Age 18 years or older
Who cannot join
- Prior enrollment in this study
- Ongoing serious infection that is a contraindication for treatment with steroids
- Pregnancy
- Medical situations (prior acute diseases) where treatment with intravenous steroids over short period of time is contraindicated or not favorable.
- Enhanced cognitive dysfunction
- Treatment with p.o or i.v steroids within 3 weeks prior to date of inclusion
Trial locations and contacts
1 site in 1 country.
Norway1 site
Innlandet Hosptal Trust-Lillehammer, Neurological Department
Lillehammer, Oppland, 2609
About this study
Official title: Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?
The Immunological system is showing a diurnal rhythmicity. The Mediators that enhances inflammation are at highest level during the night. At the same time the endogenous production of cortisol is at its lowest. We want to study if there is a better effect of treatment with Methylprednisolone for acute MS-attacks if given at nighttime. The effect will be measured in relation to neurological deficits and function with Kurtzkes Expanded Disability Status Score (EDSS) and Multiple Sclerosis Functional Composite (MSFC). We want to see if the mean improvement in EDSS is greater in the group receiving treatment at night opposed to the group that get treatment during the daytime.
- Conditions
- Multiple Sclerosis
- Being tested
- methylprednisolone, Sodium chlorid
- Keywords
- EDSS, methylprednisolone, circadian rhythms, MSFC
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Solu-Medrol. ACT-nr:H02A B04
1 gram intravenous a day for 3 days
Sodium chloridDrug
Also called ATC: B05B B01
Sodium chlorid 9mg/ml 500 ml per day in 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy) Receives: Drug: methylprednisolone; Drug: Sodium chlorid |
| 2 | Active comparator | Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid. Receives: Drug: methylprednisolone; Drug: Sodium chlorid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day.
Measured: At admittion, directly after treatment, ca 30 days after treatment
Secondary outcomes (6)
The difference in MSFC-score in the two groups
Measured: At admittion, directly after treatment, ca 30 days after treatment
Side effect registered by the patient
Measured: At admittion (baseline), during treatment, directly after treatment
The patient's quality of life
Measured: At admittion, directly after treatment, 7 days and ca 30 days after treatment
MRI - volume and number for MS-lesions, Gd-enhancement
Measured: At admission, directly after treatment and ca 30 days after treatment
Fatigue
Measured: Before, after and ca 30 days after treatment
Depression
Measured: Before, after and ca 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startApr 2009
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Low inclusion frequency and not enough human resources for completing study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anette H Farmen, Physician/MD, Study director, Innlandet Hospital Trust Lillehammer, Neurological DepartmentKristin I Løken-Amsrud, Physician/MD, Study director, Innlandet Hospital Trust Lillehammer, Neurological DepartmentElisabeth G Celius, MD/PhD, Study chair, Oslo University Hospital, Ullevål, Neurological DepartmentPer O Vandvik, MD/PhD, Study chair, Innlandet Hospital Trust Gjøvik, Department of Internal medicinTrygve Holmøy, MD/PhD, Study chair, Oslo University Hospital, Ullevål, Neurological department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764413
- Sponsor's protocol ID
- 15002
- Other IDs
- 150134, 2008-002025-37, 2008
- Status last verified
- Feb 2014
- First submitted
- 1 Oct 2008
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?
- ClinicalTrials.gov ID
- NCT00764413
- Acronym / sponsor ID
- 15002
- Conditions
- Multiple Sclerosis
- Keywords
- EDSS, methylprednisolone, circadian rhythms, MSFC
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low inclusion frequency and not enough human resources for completing study
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Oct 2008 (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.
The Immunological system is showing a diurnal rhythmicity. The Mediators that enhances inflammation are at highest level during the night. At the same time the endogenous production of cortisol is at its lowest. We want to study if there is a better effect of treatment with Methylprednisolone for acute MS-attacks if given at nighttime. The effect will be measured in relation to neurological deficits and function with Kurtzkes Expanded Disability Status Score (EDSS) and Multiple Sclerosis Functional Composite (MSFC). We want to see if the mean improvement in EDSS is greater in the group receiving treatment at night opposed to the group that get treatment during the daytime.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: methylprednisolone, Drug: Sodium chloridBoth study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy) |
| 2 | Active comparator | Drug: methylprednisolone, Drug: Sodium chloridBoth arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Relapsing remitting MS
- EDSS-score before the actual attack < 6.0
- Acute MS-attack with indication for treatment with steroids
- Symptoms >24 hours < 4 weeks
- Age 18 years or older
Key exclusion criteria (6 listed)
- Prior enrollment in this study
- Ongoing serious infection that is a contraindication for treatment with steroids
- Pregnancy
- Medical situations (prior acute diseases) where treatment with intravenous steroids over short period of time is contraindicated or not favorable.
- Enhanced cognitive dysfunction
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 |
|---|---|---|
| methylprednisoloneAlso: Solu-Medrol. ACT-nr:H02A B041 gram intravenous a day for 3 days | Drug | 1, 2 |
| Sodium chloridAlso: ATC: B05B B01Sodium chlorid 9mg/ml 500 ml per day in 3 days | Drug | 1, 2 |
Primary outcome
The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day.
Time frame: At admittion, directly after treatment, ca 30 days after treatment
6 secondary outcomes
The difference in MSFC-score in the two groups
Time frame: At admittion, directly after treatment, ca 30 days after treatment
Side effect registered by the patient
Time frame: At admittion (baseline), during treatment, directly after treatment
The patient's quality of life
Time frame: At admittion, directly after treatment, 7 days and ca 30 days after treatment
MRI - volume and number for MS-lesions, Gd-enhancement
Time frame: At admission, directly after treatment and ca 30 days after treatment
Fatigue
Time frame: Before, after and ca 30 days after treatment
Depression
Time frame: Before, after and ca 30 days after treatment
Results and safety
The study was stopped early (reason given: Low inclusion frequency and not enough human resources for completing study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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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.
Anette H Farmen, Physician/MD study director
Innlandet Hospital Trust Lillehammer, Neurological Department
Kristin I Løken-Amsrud, Physician/MD study director
Innlandet Hospital Trust Lillehammer, Neurological Department
Elisabeth G Celius, MD/PhD study chair
Oslo University Hospital, Ullevål, Neurological Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylprednisolone and Sodium chlorid in people with Multiple Sclerosis, run by Sykehuset Innlandet HF at 1 site in Norway.
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 5 inclusion and 6 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 24 Nov 2014. 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 Norway. 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.
Are results available for this study?
The study was stopped early (reason given: Low inclusion frequency and not enough human resources for completing 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?
The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day. (time frame: At admittion, directly after treatment, ca 30 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2014.