NCT02686788

TMP001 in Relapsing-remitting Multiple Sclerosis

TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Dr. Frank Behrens · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2016-02-22
• Last updated: 2018-11-21

Locations

5 sites across 1 country: Germany