Relapsing Remitting Multiple SclerosisPhase 2NCT00616187
Atorvastatin in Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing interferon beta treatment to add-on atorvastatin treatment and untreated to atorvastatin treatment in people with Relapsing Remitting Multiple Sclerosis, run by Charite University, Berlin, Germany.
Trial summary
A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- interferon beta treatment to add-on atorvastatin treatment and untreated to atorvastatin treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Jun 2007
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 55 years old
- MS diagnosis according McDonald criteria
- Relapsing-remitting MS
- EDSS 0 - 6
- Disease activity as occurrence of CEL in brain MRI
- IFN-beta therapy for at least 6 months
Who cannot join
- Primary chronic progressive MS
- Symptoms and signs of clinical disease conditions similar to MS
- Conditions that can disturb MRI measurements
- Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus pepticum
- Clinically relevant lung, heart, CNS, infectious disease
- Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific clinical chemistry values)
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- Allergies towards Gd-DTPA
- Allergies towards constituents of the therapeutic agent
- Recruitment to other clinical trials within 6 months prior to or during this study
- Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A, human antibodies, all immunomodulatory or immunosuppressive agents including recombinant cytokines or other potential experimental MS therapies (6 months prior to study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start) pregnancy or lactation
- Alcohol or drug abuse
- Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole antimycotics).
- Medical or psychological conditions that could hamper with the patients capacity to understand patient information, to give the informed consent, to adhere to the protocol of the study and to be able to complete the study
About this study
Official title: Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis
A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- interferon beta treatment to add-on atorvastatin treatment, untreated to atorvastatin treatment
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon beta treatment to add-on atorvastatin treatmentDrug
IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)
untreated to atorvastatin treatmentDrug
no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)
| Study group | Role | What they receive |
|---|---|---|
| interferon | Active comparator | Not described Receives: Drug: interferon beta treatment to add-on atorvastatin treatment |
| untreated | Sham comparator | Not described Receives: Drug: untreated to atorvastatin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of MRI contrast enhancing lesions
Measured: treatment months 6 to 9 compared to baseline
Secondary outcomes (1)
other MRI-based parameters (CEL volume, T2-lesion load, T1-hypointense lesion volume, whole brain magnetization transfer ratio, and apparent diffusion coefficient of normal appearing white matter)
Measured: treatment months 6 to 9 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startOct 2003
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, German Federal Ministry of Education and Research, Pfizer
- Investigators
- Frauke Zipp, MD, Principal investigator, Cecilie Vogt Clinic for Neurology, Charite, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616187
- Sponsor's protocol ID
- 1931/Si.270 am 8.5.03
- Other IDs
- ATV-D-03-007G
- Status last verified
- Dec 2017
- First submitted
- 5 Feb 2008
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paul F, Waiczies S, Wuerfel J, Bellmann-Strobl J, Dorr J, Waiczies H, Haertle M, Wernecke KD, Volk HD, Aktas O, Zipp F. Oral high-dose atorvastatin treatment in relapsing-remitting multiple sclerosis. PLoS One. 2008 Apr 9;3(4):e1928. doi: 10.1371/journal.pone.0001928.
PubMed 18398457
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00616187
- Acronym / sponsor ID
- 1931/Si.270 am 8.5.03
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation, German Federal Ministry of Education and Research, Pfizer
- Study start
- Oct 2003
- Primary completion
- Jun 2007 (actual)
- First posted
- 15 Feb 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.
A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interferon | Active comparator | Drug: interferon beta treatment to add-on atorvastatin treatment |
| untreated | Sham comparator | Drug: untreated to atorvastatin treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 - 55 years old
- MS diagnosis according McDonald criteria
- Relapsing-remitting MS
- EDSS 0 - 6
- Disease activity as occurrence of CEL in brain MRI
Key exclusion criteria (13 listed)
- Primary chronic progressive MS
- Symptoms and signs of clinical disease conditions similar to MS
- Conditions that can disturb MRI measurements
- Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus pepticum
- Clinically relevant lung, heart, CNS, infectious disease
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 |
|---|---|---|
| interferon beta treatment to add-on atorvastatin treatmentIFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment) | Drug | interferon |
| untreated to atorvastatin treatmentno treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment) | Drug | untreated |
Primary outcome
number of MRI contrast enhancing lesions
Time frame: treatment months 6 to 9 compared to baseline
1 secondary outcome
other MRI-based parameters (CEL volume, T2-lesion load, T1-hypointense lesion volume, whole brain magnetization transfer ratio, and apparent diffusion coefficient of normal appearing white matter)
Time frame: treatment months 6 to 9 compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Derived from this study: PubMed 18398457Paul F, Waiczies S, Wuerfel J, Bellmann-Strobl J, Dorr J, Waiczies H, Haertle M, Wernecke KD, Volk HD, Aktas O, Zipp F. Oral high-dose atorvastatin treatment in relapsing-remitting multiple sclerosis. PLoS One. 2008 Apr 9;3(4):e1928. doi: 10.1371/journal.pone.0001928.
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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.
Frauke Zipp, MD principal investigator
Cecilie Vogt Clinic for Neurology, Charite, Berlin
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interferon beta treatment to add-on atorvastatin treatment and untreated to atorvastatin treatment in people with Relapsing Remitting Multiple Sclerosis, run by Charite University, Berlin, Germany.
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 6 inclusion and 13 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
number of MRI contrast enhancing lesions (time frame: treatment months 6 to 9 compared to baseline). 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 NCT00616187, 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 20 Mar 2018.