Relapsing Remitting Multiple SclerosisPhase 2NCT01428726
A Phase IIa Study of NT-KO-003 for Multiple Sclerosis
A Phase 2 study testing NT-KO-003 in people with Relapsing Remitting Multiple Sclerosis, run by Neurotec Pharma at 17 sites in 2 countries.
Trial summary
The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of relapsing remitting multiple sclerosis, comparing two doses versus placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- NT-KO-003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jun 2011to Jan 2014
- 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
- Patients who meet the diagnosis criteria for MS according to guidelines provided by McDonald et al (1)
- Patients who meet the diagnosis criteria for RRMS
- Patients with clinical disability measured by EDSS score between 0 and 5.0 inclusive
- Patients who present at least 1 relapse in the previous 2 years or presence of at least 1 gadolinium-enhanced lesion in the previous 1 year
- Patients aged between 18 to 55 years old, either gender
Who cannot join
- Patients who are candidates for treatment with drugs modifying the course of the disease according to the criteria of the Regulatory Agencies in each country, unless the patient refuses to initiate such therapy or decide to postpone the start of this therapy
- Patients with relapse in the 30 days period before baseline visit
- Patients in treatment with NT-KO-003
- Medical conditions such as hypotension, insulinoma, hyperuricemia
- Patients with Diabetes defined by ADA criteria (2)
- Other conditions: drug abuse, inability to consent, or inability to perform all the procedures for the Clinical Trial
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- Contraindications for MRI studies: claustrophobia, heart pacemaker or any other condition that would preclude proximity to strong magnetic field
- Contraindications for treatment with NT-KO-003 or excipients: allergies, hypersensitivity
- Patients with known allergy or with contraindications to the administration of intravenous gadolinium-based agents (chronic or acute renal failure according to The Renal Association or NICE guidelines (3))
- Corticosteroid therapy in the last month
- Interferon-beta or Glatiramer acetate therapy in the last 3 months
- Natalizumab therapy in the last 6 months
- Patients treated with chemotherapy (Mitoxantrone, Azathioprine, Cyclophosphamide, Cladribine, Methotrexate) or monoclonal antibodies that deplete populations of cells (rituximab, alemtuzumab, ocrelizumab, daclizumab) in the last 12 months or have entered in previous trials with treatments in development in the last 3 months
- Patients participating in another Clinical Trial at the moment of the screening visit
- Patient who had received a liver transplantation or candidates for liver transplantation
- Positive pregnancy test, breast feeding women or of childbearing potential not using highly effective methods of contraception
- Male patients that do not follow adequate contraceptive measurements
- Fingolimod therapy in the last 6 months
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Spain14 sites
Hospital Germans Trias i Pujol
Badalona
Hospital Clinic i Provincial
Barcelona
Hospital del Mar
Barcelona
Hospital Vall d'Hebrón
Barcelona
Hospital Universitari Josep Trueta
Girona
Hospital Clínico San Carlos
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario La Princesa
Madrid
Hospital Universitario Puerta del Hierro
Madrid
Hospital Regional Universitario Carlos Haya
Málaga
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela
Hospital Universitario La Fe
Valencia
Hospital Xeral Vigo
Vigo
Germany3 sites
Charité Universitätsmedizin
Berlin
Klinik und Poliklinik für Neurologie
Münster
Neurologisches Studienzentrum an der Stiftung Deutsche Klinik für Diagnostik GmbH
Wiesbaden
About this study
Official title: A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of Low Doses of Oral NT-KO-003 for the Treatment of Multiple Sclerosis
The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of relapsing remitting multiple sclerosis, comparing two doses versus placebo.
Read the detailed description
This is a Phase IIa study, double blind, placebo Controlled, Multicenter Study that will involve up to 99 patients with relapsing remitting multiple sclerosis.
After signing the informed consent form, subjects will be randomized to three treatments arms: placebo, NT-KO-003 low dose or NT-KO-003 high dose. Treatment will continue daily during 6 months. A MRI and a clinical evaluation will be performed monthly. Safety will be assessed during the 6 months treatment and until 15 days after the finalization of the treatment.
Patients will be allowed to continue in the same arm of the study, in a blinded way, until the study finalizes as optional extension treatment. Patient will sign the Extension Informed Consent and a MRI will be performed for those patients still in treatment after 12 months of the inclusion in the core study (visit 0).
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- NT-KO-003
- Keywords
- NT-KO-003, RRMS, efficacy, safety, Phase IIa
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-KO-003Drug
NT-KO-003 is a coated tablet, administered once a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: NT-KO-003 |
| NT-KO-003 low dose | Experimental | Not described Receives: Drug: NT-KO-003 |
| NT-KO-003 high dose | Experimental | Not described Receives: Drug: NT-KO-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of NT-KO-003 in patients with relapsing remitting MS patients
efficacy will be measured as the cumulative number of new lesions observed in all MRIs, with exception of baseline
Measured: 6 months
Secondary outcomes (3)
Efficacy of NT-KO-003 in relapsing remitting MS patients
efficacy measured as the cumulative number of new lesions (gadolinium enhanced lesions and T2 lesions) in all MRIs
Measured: 6 months
Clinical efficacy of NT-KO-003 in relapsing remitting MS patients
clinical efficacy will be measured as relapse rates and EDSS scale
Measured: 6 months
Safety of NT-KO-003 in patients with relapsing remitting MS patients
safety will be measured as the incidence of adverse events and serious adverse events (incidence, causality, and severity) related to treatment with NT-KO-003
Measured: six and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurotec Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advancell - Advanced In Vitro Cell Technologies, S.A.
- Responsible party
- Sponsor
- Investigators
- Pablo Villoslada, MD PhD, Principal investigator, Hospital Clinic i Provincial de Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428726
- Sponsor's protocol ID
- NT-KO-003-2010-01
- Status last verified
- Mar 2014
- First submitted
- 31 Aug 2011
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of Low Doses of Oral NT-KO-003 for the Treatment of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01428726
- Acronym / sponsor ID
- NT-KO-003-2010-01
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- NT-KO-003, RRMS, efficacy, safety, Phase IIa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Neurotec PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Advancell - Advanced In Vitro Cell Technologies, S.A.
- Study start
- Jun 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of relapsing remitting multiple sclerosis, comparing two doses versus placebo.
Detailed description
This is a Phase IIa study, double blind, placebo Controlled, Multicenter Study that will involve up to 99 patients with relapsing remitting multiple sclerosis.
After signing the informed consent form, subjects will be randomized to three treatments arms: placebo, NT-KO-003 low dose or NT-KO-003 high dose. Treatment will continue daily during 6 months. A MRI and a clinical evaluation will be performed monthly. Safety will be assessed during the 6 months treatment and until 15 days after the finalization of the treatment.
Patients will be allowed to continue in the same arm of the study, in a blinded way, until the study finalizes as optional extension treatment. Patient will sign the Extension Informed Consent and a MRI will be performed for those patients still in treatment after 12 months of the inclusion in the core study (visit 0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: NT-KO-003 |
| NT-KO-003 low dose | Experimental | Drug: NT-KO-003 |
| NT-KO-003 high dose | Experimental | Drug: NT-KO-003 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who meet the diagnosis criteria for MS according to guidelines provided by McDonald et al (1)
- Patients who meet the diagnosis criteria for RRMS
- Patients with clinical disability measured by EDSS score between 0 and 5.0 inclusive
- Patients who present at least 1 relapse in the previous 2 years or presence of at least 1 gadolinium-enhanced lesion in the previous 1 year
- Patients aged between 18 to 55 years old, either gender
Key exclusion criteria (18 listed)
- Patients who are candidates for treatment with drugs modifying the course of the disease according to the criteria of the Regulatory Agencies in each country, unless the patient refuses to initiate such therapy or decide to postpone the start of this therapy
- Patients with relapse in the 30 days period before baseline visit
- Patients in treatment with NT-KO-003
- Medical conditions such as hypotension, insulinoma, hyperuricemia
- Patients with Diabetes defined by ADA criteria (2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-KO-003NT-KO-003 is a coated tablet, administered once a day | Drug | NT-KO-003 high dose, NT-KO-003 low dose, Placebo |
Primary outcome
Efficacy of NT-KO-003 in patients with relapsing remitting MS patients
Time frame: 6 months
efficacy will be measured as the cumulative number of new lesions observed in all MRIs, with exception of baseline
3 secondary outcomes
Efficacy of NT-KO-003 in relapsing remitting MS patients
Time frame: 6 months
Clinical efficacy of NT-KO-003 in relapsing remitting MS patients
Time frame: 6 months
Safety of NT-KO-003 in patients with relapsing remitting MS patients
Time frame: six and a half months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Villoslada, MD PhD principal investigator
Hospital Clinic i Provincial de Barcelona, Spain
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NT-KO-003 in people with Relapsing Remitting Multiple Sclerosis, run by Neurotec Pharma at 17 sites in 2 countries.
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 5 inclusion and 18 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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, 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. Some participants in this study may receive a placebo. 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?
Efficacy of NT-KO-003 in patients with relapsing remitting MS patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2014.