Relapsing Remitting Multiple SclerosisPhase 2FLORIMSNCT00623415
Flupirtine as Oral Treatment in Multiple Sclerosis
A Phase 2 study testing Flupirtine in people with Relapsing Remitting Multiple Sclerosis, run by Charite University, Berlin, Germany at 4 sites in Germany.
Trial summary
Flupirtine, a non-opioid analgesic drug, that has been shown to have additional neuroprotective functions, is given twice daily as an oral medication in patients with relapsing remitting multiple sclerosis over a period of 12 months. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Flupirtine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesGermany
- Study dates
- Dec 2007to Nov 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
- EDSS ≤ 4.0
- Stable treatment with Interferon-β1b for at least 6 months
- Sufficient birth control (Pearl-Index <1)
Who cannot join
- Any other MS-course than RRMS
- Clinically relevant gastrointestinal disease
- Clinically relevant pulmonary, cardiological, infectious or CNS-disease
- Clinically relevant disease of liver or bile system, pathological value for transaminases, gamma-GT or bilirubin.
- Hepatitis (except uncomplicated hepatitis A with complete remission
- Clinically relevant dysfunction of kidneys (creatinine >180 µmol/l) or bone marrow (HB < 8.5 g/dl, WBC < 2.5/nl thrombocytes < 125/nl)
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- Myasthenia gravis
- Oral anticoagulation (phenprocoumon)
- Treatment with carbamazepine or paracetamol
- Drug or alcohol abuse
- Pregnancy or lactation period
- Treatment at any time before or during study with complete lymphoradiation, monoclonal antibodies (e.g. anti-CD4, Campath 1H, natalizumab), mitoxantrone, cyclophosphamide, cyclosporin, azathioprine
- Treatment within 6 months before randomization with any other immunomodulatory substance than interferon-β1b or intravenous methylprednisolone
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
NeuroCure Clinical Research Center, Charité Berlin
Berlin, 10117
Carl-Thiem-Clinic Cottbus
Cottbus, 03048
University of Göttingen, Department of Neurology
Göttingen, 37075
University of Ulm, Department of Neurology
Ulm
About this study
Official title: Multicentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-β1b on Neurodegeneration in Patients With Relapsing Remitting Multiple Sclerosis
Flupirtine, a non-opioid analgesic drug, that has been shown to have additional neuroprotective functions, is given twice daily as an oral medication in patients with relapsing remitting multiple sclerosis over a period of 12 months. Neuroprotection is assessed by magnetic resonance imaging, magnetic resonance spectroscopy, optical coherence tomography, and clinical examination.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Flupirtine, Placebo
- 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.
FlupirtineDrug
300 mg daily (divided in two doses)
PlaceboDrug
twice daily
| Study group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | flupirtine + interferon beta 1b Receives: Drug: Flupirtine |
| Placebo | Placebo comparator | placebo + interferon beta 1b Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)
Measured: 12 months
Secondary outcomes (4)
Cerebral atrophy (brain parenchymal fraction)
Measured: 12 months
Number of new and total gadolinium(Gd)-enhancing lesions
Measured: 12 months
Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))
Measured: 12 months
Retinal nerve fiber layer thickness, assessed by Optical coherence tomography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Friedemann Paul, MD, Principal investigator, NeuroCure Clinical Research Center, Charité Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623415
- Sponsor's protocol ID
- 2006-005262-39
- Acronym
- FLORIMS
- Status last verified
- Dec 2017
- First submitted
- 15 Feb 2008
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
- Multicentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-β1b on Neurodegeneration in Patients With Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00623415
- Acronym / sponsor ID
- FLORIMS / 2006-005262-39
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Dec 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 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.
Flupirtine, a non-opioid analgesic drug, that has been shown to have additional neuroprotective functions, is given twice daily as an oral medication in patients with relapsing remitting multiple sclerosis over a period of 12 months. Neuroprotection is assessed by magnetic resonance imaging, magnetic resonance spectroscopy, optical coherence tomography, and clinical examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Drug: Flupirtineflupirtine + interferon beta 1b |
| Placebo | Placebo comparator | Drug: Placeboplacebo + interferon beta 1b |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
- EDSS ≤ 4.0
- Stable treatment with Interferon-β1b for at least 6 months
- Sufficient birth control (Pearl-Index <1)
Key exclusion criteria (13 listed)
- Any other MS-course than RRMS
- Clinically relevant gastrointestinal disease
- Clinically relevant pulmonary, cardiological, infectious or CNS-disease
- Clinically relevant disease of liver or bile system, pathological value for transaminases, gamma-GT or bilirubin.
- Hepatitis (except uncomplicated hepatitis A with complete remission
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 |
|---|---|---|
| Flupirtine300 mg daily (divided in two doses) | Drug | Verum |
| Placebotwice daily | Drug | Placebo |
Primary outcome
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)
Time frame: 12 months
4 secondary outcomes
Cerebral atrophy (brain parenchymal fraction)
Time frame: 12 months
Number of new and total gadolinium(Gd)-enhancing lesions
Time frame: 12 months
Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))
Time frame: 12 months
Retinal nerve fiber layer thickness, assessed by Optical coherence tomography
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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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.
Friedemann Paul, MD principal investigator
NeuroCure Clinical Research Center, Charité Berlin, Germany
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flupirtine in people with Relapsing Remitting Multiple Sclerosis, run by Charite University, Berlin, Germany at 4 sites in 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 4 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: stopped early, 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.
Where is the study taking place?
The record lists 4 sites in Germany. 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 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 was stopped early. 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?
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI) (time frame: 12 months). 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 20 Mar 2018.