Flupirtin as Oral Treatment in MS - FLORIMS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005262-39-DE

Enrollment

Registered

2007-03-09

Start date

2007-05-30

Completion date

Unknown

Last updated

2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-remitting multiple sclerosis

Interventions

Trade Name: Trancopal Dolo Product Name: Flupirtin Pharmaceutical Form: Capsule, hard INN or Proposed INN: Flupirtin CAS Number: 56995-20-1 Other descriptive name: Flupirtinmaleat Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: written informed consent, age 18-55 yrs. at randomization, RR-MS according to revised McDonald criteria (2005), EDSS 6 months, in women reliable contraception (Pearl index =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: all other forms of MS apart from RR-MS, any other illness that could explain symptoms better than RR-MS, any condition preventing/ disturbing cMRI or other examinations, relevant gastrointestinal, pulmonary, infectious, heart or CNS disease, relevant liver disease, cholestasis, elevated liver enzymes and bilirubin, bone marrow dysfunction, renal dysfunction, myasthenia gravis, allergy against gadolinium-DTPA, flupirtin maleat or additives, treatment with drugs toxic to liver, anticoagulants, carbamazepine or paracetamol, alcohol or drug abuse, pregnancy, lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of efficacy and safety of flupirtin compared to placebo as an add-on to treatment with IFN-beta in RR-MS. Primary objectives are the incidence of new T2-lesions, the number of patients without newly occurring T2 lesions over the treatmant period, "lesion load", number and volume of "black holes", "brain parenchymal fraction" measured by cerebral MRI and changes in the relation of NAA and choline measured by MRS. ;Secondary Objective: Secondary objectives are the annualized number of relapses over 12 months of flupirtin treatment compared to 12 months prior to treatment, the number of patients without relapse, progression of disability, parameters of neuronal atrophy, cognitive/ neuropsychological parameters and the effects of flupirtin on peripheral mononuclear blood cells compared to placebo. ;Primary end point(s): Primary objectives are the incidence of new T2-lesions, the number of patients without newly occurring T2 lesions over the treatmant period, "lesion load", number and volume of "black holes", "brain parenchymal fraction" measured by cerebral MRI and changes in the relation of NAA and choline measured by MRS.	—

Measure

Time frame

Main Objective: Assessment of efficacy and safety of flupirtin compared to placebo as an add-on to treatment with IFN-beta in RR-MS. Primary objectives are the incidence of new T2-lesions, the number of patients without newly occurring T2 lesions over the treatmant period, "lesion load", number and volume of "black holes", "brain parenchymal fraction" measured by cerebral MRI and changes in the relation of NAA and choline measured by MRS. ;Secondary Objective: Secondary objectives are the annualized number of relapses over 12 months of flupirtin treatment compared to 12 months prior to treatment, the number of patients without relapse, progression of disability, parameters of neuronal atrophy, cognitive/ neuropsychological parameters and the effects of flupirtin on peripheral mononuclear blood cells compared to placebo. ;Primary end point(s): Primary objectives are the incidence of new T2-lesions, the number of patients without newly occurring T2 lesions over the treatmant period, "lesion load", number and volume of "black holes", "brain parenchymal fraction" measured by cerebral MRI and changes in the relation of NAA and choline measured by MRS.

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026