TMP001 in Relapsing-remitting Multiple Sclerosis

NCT ID: NCT02686788

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMP001

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

Group Type: EXPERIMENTAL

TMP001

Intervention Type: DRUG

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

Interventions

TMP001

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• History of drug or alcohol abuse within 2 years of inclusion to the study
• 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)

• Patients with known hypersensitivity to study medication
• Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Patients with a history of peptic ulcer disease and/or gastrointestinal bleeding
• Chronic or acute renal, hepatic or metabolic disorder
• Patients with a history of myocardial infarction, ischemic stroke or known heart failure
• Patients with known thrombophilia or abnormal clinically significant coagulation parameter at screening (week -4)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SocraMetrics GmbH

INDUSTRY

Sponsor Role: collaborator

Dr. Frank Behrens

OTHER

Sponsor Role: lead

Responsible Party

Dr. Frank Behrens

head of clinical research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ulf Ziemann, MD

Role: PRINCIPAL_INVESTIGATOR

University Department of Neurology Tübingen

Locations

UKT, Universitätsklinikum Tübingen

Tübingen, Baden-Würtemberg, Germany

Goethe-Universität Frankfurt am Main

Frankfurt am Main, Hesse, Germany

Universitätsklinikum Münster, Klinik für Allgemeine Neurologie

Münster, North Rhine-Westphalia, Germany

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

Berlin, , Germany

Universitätsklinikum Heidelberg Neurologische Klinik

Heidelberg, , Germany

Countries

Germany

Other Identifiers

TMP001_MS

Identifier Type: -

Identifier Source: org_study_id