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Remitting-Relapsing Multiple SclerosisPhase 2NCT02686788

TMP001 in Relapsing-remitting Multiple Sclerosis

A Phase 2 study testing TMP001 in people with Remitting-Relapsing Multiple Sclerosis, run by Dr. Frank Behrens at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Remitting-Relapsing Multiple Sclerosis
What is being tested?
TMP001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
5 sitesGermany
Study dates
Aug 2015to Apr 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

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

    Berlin, 10177

  • Goethe-Universität Frankfurt am Main

    Frankfurt am Main, Hesse, 60528

  • Universitätsklinikum Heidelberg Neurologische Klinik

    Heidelberg, 69120

  • Universitätsklinikum Münster, Klinik für Allgemeine Neurologie

    Münster, North Rhine-Westphalia, 48149

  • UKT, Universitätsklinikum Tübingen

    Tübingen, Baden-Würtemberg, 72076

Other trials in Germany

About this study

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

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.

Being tested
TMP001
Keywords
multiple sclerosis, relapsing remitting, nonsteroidal anti-inflammatory drug, contrast enhancing lesions
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMP001Drug

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

Study groups in NCT02686788
Study groupRoleWhat they receive
TMP001Experimental600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks
Receives: Drug: TMP001

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (8)

  1. Comparison of average total volume of contrast enhancing lesions

    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

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

  2. Comparison of T2- hyperintense lesions as assessed in MRI

    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

    Measured: at week 0 (baseline) and week 24

  3. Comparison of T1-hypointense lesions as assessed in MRI

    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

    Measured: at week 0 (baseline) and week 24

  4. relapse rate

    Documentation of any replapse during study period to determine the annualised relapse rate

    Measured: week -4 until week 24

  5. Expanded disability status scale (EDSS)

    EDSS at weeks 12 and 24 as compared to baseline

    Measured: at week 0 (baseline), week 12 and 24

  6. Assessment of Lipid profile at different time points

    Concentration of a variety of lipids will be determined at weeks 12 and 24 and described in comparison to the lipid profile at baseline

    Measured: at week 0 (baseline), week 12 and 24

  7. TMP001-concentrations

    Assessment of TMP001-concentrations

    Measured: week 4, 8, 12, 16, 20 and 24

  8. Pain questionnaire

    Pain questionnaire at BL, week 12 and week 24

    Measured: at week 0 (baseline), week 12 and week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionApr 2018
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02686788
Sponsor's protocol ID
TMP001_MS
Status last verified
Nov 2018
First submitted
14 Oct 2015
Last updated
21 Nov 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TMP001 in people with Remitting-Relapsing Multiple Sclerosis, run by Dr. Frank Behrens at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of average total number of contrast enhancing lesions (time frame: at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02686788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.

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