TMP001 in Relapsing-remitting Multiple Sclerosis

Sponsor

Dr. Frank Behrens (Other)

Overall Status

Completed

CT.gov ID

NCT02686788

Collaborator

SocraMetrics GmbH (Industry)

Enrollment

Locations

Arm

Duration (Months)

1.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Remitting-Relapsing Multiple Sclerosis	Drug: TMP001	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TMP001 600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks	Drug: TMP001 600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks

Arm

Intervention/Treatment

Experimental: TMP001

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

Drug: TMP001

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

Outcome Measures

Primary Outcome Measures

Comparison of average total number of contrast enhancing lesions [at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24]
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)

Secondary Outcome Measures

Comparison of average total volume of contrast enhancing lesions [at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24]
Average total volume of CELs (in mm3) on brain MRI scans at week 4,8, 12, 16, 20 and 24 as compared to the average total CEL volume on brain MRI scans at week -4 and BL
Comparison of T2- hyperintense lesions as assessed in MRI [at week 0 (baseline) and week 24]
New or enlarged T2- hyperintense lesions at week 24 as compared to baseline - Number and Characteristics of T2-hyperintense leasion as to be found in MRI Assessment in Comparison between baseline and week 24
Comparison of T1-hypointense lesions as assessed in MRI [at week 0 (baseline) and week 24]
New T1-hypointense lesions at week 24 as compared to baseline as to be found in MRI Assessment in Comparison between baseline and week 24
relapse rate [week -4 until week 24]
Documentation of any replapse during study period to determine the annualised relapse rate
Expanded disability status scale (EDSS) [at week 0 (baseline), week 12 and 24]
EDSS at weeks 12 and 24 as compared to baseline
Assessment of Lipid profile at different time points [at week 0 (baseline), week 12 and 24]
Concentration of a variety of lipids will be determined at weeks 12 and 24 and described in comparison to the lipid profile at baseline
TMP001-concentrations [week 4, 8, 12, 16, 20 and 24]
Assessment of TMP001-concentrations
Pain questionnaire [at week 0 (baseline), week 12 and week 24]
Pain questionnaire at BL, week 12 and week 24

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Exclusion criteria regarding the study medication:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UKT, Universitätsklinikum Tübingen	Tübingen	Baden-Würtemberg	Germany	72076
2	Goethe-Universität Frankfurt am Main	Frankfurt am Main	Hessen	Germany	60528
3	Universitätsklinikum Münster, Klinik für Allgemeine Neurologie	Münster	Nordrhein-Westfalen	Germany	48149
4	Charite- Universitätsmedizin Berlin (Campus Mitte) NeuroCure Clinical Research Center NCRC AG Klinische Neuroimmunologie	Berlin		Germany	10177
5	Universitätsklinikum Heidelberg Neurologische Klinik	Heidelberg		Germany	69120