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TMP001 in Relapsing-remitting Multiple Sclerosis

NCT02686788 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-11-21

No results posted yet for this study

Summary

The purpose of this study is to assess the impact of TMP001 in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Therefore the average total number of contrast enhancing lesions (CELs) on brain MRI scans at weeks 12, 16, 20, and 24 during treatment with TMP001 is compared to the average total number of CELs on brain MRI scans at week -4 and baseline in these patients .

Based on promising preclinical results, the investigators assume a comparable effect of TMP001 on reduction of contrast-enhancing lesions as shown for other immunomodulatory substances in recent clinical studies.

Conditions

  • Remitting-Relapsing Multiple Sclerosis

Interventions

DRUG

TMP001

600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks

Sponsors & Collaborators

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • Dr. Frank Behrens

    lead OTHER

Principal Investigators

  • Ulf Ziemann, MD · University Department of Neurology Tübingen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02686788 on ClinicalTrials.gov