Flupirtine as Oral Treatment in Multiple Sclerosis | NCT00623415

Studies
Flupirtine as Oral Treatment in Multiple Sclerosis

NCT00623415

Sponsor

Charite University, Berlin, Germany

Status

Terminated

Last Update Posted

Mar 20, 2018Actual

Enrollment

30Actual

Phase

Phase 2

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

Flupirtine
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Feb 15, 2008

First Submission Date that Met QC Criteria

Feb 15, 2008

First Posted Date

Feb 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2018

Last Update Posted Date

Mar 20, 2018Actual

Name	Class
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Verum	Active Comparator	flupirtine + interferon beta 1b	Drug: Flupirtine
Placebo	Placebo Comparator	placebo + interferon beta 1b	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flupirtine	Drug	300 mg daily (divided in two doses)	Verum
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)		12 months

Secondary Outcomes

Measure	Description	Time Frame
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))

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Friedemann Paul, MD	NeuroCure Clinical Research Center, Charité Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NeuroCure Clinical Research Center, Charité Berlin		Berlin		10117	Germany
Carl-Thiem-Clinic Cottbus

Condition Browse Module

MeSH Terms

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided