NCT00623415

Brief 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. Neuroprotection is assessed by magnetic resonance imaging, magnetic resonance spectroscopy, optical coherence tomography, and clinical examination.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 20, 2018

Status Verified

December 1, 2017

Enrollment Period

4.9 years

First QC Date

February 15, 2008

Last Update Submit

March 19, 2018

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)

    12 months

Secondary Outcomes (4)

  • Cerebral atrophy (brain parenchymal fraction)

    12 months

  • Number of new and total gadolinium(Gd)-enhancing lesions

    12 months

  • Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))

    12 months

  • Retinal nerve fiber layer thickness, assessed by Optical coherence tomography

    12 months

Study Arms (2)

Verum

ACTIVE COMPARATOR

flupirtine + interferon beta 1b

Drug: Flupirtine

Placebo

PLACEBO COMPARATOR

placebo + interferon beta 1b

Drug: Placebo

Interventions

FlupirtineDRUG

300 mg daily (divided in two doses)

Verum
PlaceboDRUG

twice daily

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

NeuroCure Clinical Research Center, Charité Berlin

Berlin, 10117, Germany

Location

Carl-Thiem-Clinic Cottbus

Cottbus, 03048, Germany

Location

University of Göttingen, Department of Neurology

Göttingen, 37075, Germany

Location

University of Ulm, Department of Neurology

Ulm, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

flupirtine

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Friedemann Paul, MD

    NeuroCure Clinical Research Center, Charité Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 26, 2008

Study Start

December 1, 2007

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 20, 2018

Record last verified: 2017-12

Locations

DE(4)