TMP001 in Relapsing-remitting Multiple Sclerosis

NCT02686788 | Completed Phase 2 DMC

• 1 other identifier: TMP001_MS
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

multiple sclerosis; relapsing remitting; nonsteroidal anti-inflammatory drug; contrast enhancing lesions

Outcome Measures

Primary Outcomes (1)

• Comparison of average total number of contrast enhancing lesions

  Comparison of average total number of contrast enhancing lesions (CELs) on Brain MRI scans at weeks 4, 8, 12, 16, 20 and 24 as compared to the average total number of CELs on brain MRI scans at week -4 and baseline (BL)

  at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24

Secondary Outcomes (8)

• Comparison of average total volume of contrast enhancing lesions

  at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24

• Comparison of T2- hyperintense lesions as assessed in MRI

  at week 0 (baseline) and week 24

• Comparison of T1-hypointense lesions as assessed in MRI

  at week 0 (baseline) and week 24

• relapse rate

  week -4 until week 24

• Expanded disability status scale (EDSS)

  at week 0 (baseline), week 12 and 24

Study Arms (1)

TMP001

EXPERIMENTAL

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

Drug: TMP001

Interventions

TMP001 DRUG

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

TMP001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 55 years
• Definite diagnosis of RRMS (according to revised McDonald criteria, Polman et al. 2011, Annals of Neurology 69:292-302)
• At least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years
• At least one contrast-enhancing lesion (CEL) on the screening MRI scan at week (-4)
• EDSS of 0 - 5 (inclusive) at screening (week -4)
• Women of childbearing potential (WOCBP) must use 2 adequate forms of contraception to avoid pregnancy throughout the trial (such as a double barrier method) and for up to 8 weeks after the last dose of TMP001 in such a manner that the risk of pregnancy is minimized
• Written informed consent obtained prior to the initiation of any protocol-required procedures
• Compliance to study procedure and study protocol

You may not qualify if:

• History of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
• Clinically severe active infection (e.g., pneumonia, septicaemia) within the 1 month prior to Screening.
• Diagnosis of neuromyelitis optica, clinically isolated syndrome, secondary progressive multiple sclerosis, or primary progressive multiple sclerosis
• Relapse or corticosteroid treatment within 30 days before screening (week -4)
• Interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate or fingolimod therapy had to have been stopped 3 or more months before enrolment
• Immunosuppressive medication such as azathioprine or methotrexate, Ciclosporin, cyclophosphamide, mycophenolate mofetil, mitoxantrone or cladribine at any time
• Any previous therapy with alemtuzumab, ocrelizumab, ofatumumab, rituximab, belimumab, natalizumab, total body irradiation, or bone marrow transplantation
• Any investigational drug or placebo within 12 weeks prior to enrolment OR \> 5 half-lives prior to screening (week -4), whichever is longer
• Women that are pregnant or currently breast feeding
• Concurrent participation in other clinical trials
• History of, or current diagnosis of, malignancy (including previously treated skin cancer other than successfully treated basal and squamous skin cancer with no evidence of recurrence within 5 years)
• Inability to complete an MRI or contraindications for MRI, including but not limited to claustrophobia, presence of a pacemaker, cochlear implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, or nerve stimulators
• Hypersensitivity to contrast agent (Gadolinium, resp. gadopentetate-dimeglumine)
• Any reason in the discretion of the investigator regarding the safe participation of the patient in the study or for any other reason, the investigator considers the patient inappropriate for participation in the study.
• White blood count (WBC) \<3000 mm3 at screening (week -4)Lymphocytes \< 800 mm3 at screening (week -4)

Sponsors & Collaborators

• Dr. Frank Behrens: lead
• SocraMetrics GmbH: collaborator

Study Sites (5)

UKT, Universitätsklinikum Tübingen

Tübingen, Baden-Würtemberg, 72076, Germany

Location

Goethe-Universität Frankfurt am Main

Frankfurt am Main, Hesse, 60528, Germany

Location

Universitätsklinikum Münster, Klinik für Allgemeine Neurologie

Münster, North Rhine-Westphalia, 48149, Germany

Location

Charite- Universitätsmedizin Berlin (Campus Mitte) NeuroCure Clinical Research Center NCRC AG Klinische Neuroimmunologie

Berlin, 10177, Germany

Location

Universitätsklinikum Heidelberg Neurologische Klinik

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

tarenflurbil

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ulf Ziemann, MD

  University Department of Neurology Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: head of clinical research

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: February 22, 2016
• Study Start: August 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

DE (5)