Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Expired
Participants planned
20
Countries
1
Sites
1
Multiple Sclerosis
To study the changes in functional connectivity by DMN´s degree of activation in MS patients with cladribine tablets.
Key facts
- Sponsor
- María Luisa Martínez Ginés
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2023-06-26
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To study the changes in functional connectivity by DMN´s degree of activation in MS patients with cladribine tablets.
Secondary objectives 10
- To study DMN structural connectivity in anterior part (anterior cingulate cortex - ACC) in MS patients treated with cladribine tablets.
- To study DMN structural connectivity in posterior part (posterior cingulate cortex – PCC)
- To study DMN structural connectivity in the cerebellum and the cortico-cerebellar tracts.
- To study atrophy of grey matter in MS patients treated with cladribine tablets.
- To study the change in functional activity during a functional processing speed task in MS patients undergoing Cladribine treatment.
- To study the effect of cladribine treatment on cognitive function.
- To correlate grey matter indexes with cognitive functioning and emotional/behavioural indexes (scores from tests)
- To correlate DMN structural connectivity indexes with cognitive functioning and emotional/behavioural indexes (scores from tests)
- To correlate Image Tensor Diffusion indexes with cognitive functioning and emotional/behavioural indexes (scores from tests)
- To study clinical change in terms of annualized relapse rate (ARR), defined by Rio Score measures at baseline and 18 months later.
Conditions and MedDRA coding
Multiple Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10028245 | Multiple sclerosis | 100000004852 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A phase IV, unicentric, open label clinical trial A phase IV, unicentric, open label clinical trial
|
2 | None | Cladribine: Single Arm |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- MS diagnostic following McDonald 2010 diagnosis criteria.
- Age between 30 and 55 years old.
- MS patients that started treatment with cladribine tablets in the last month.
- Consent form signature
Exclusion criteria 6
- Dementia diagnosis, following Spanish Neurological Society criteria.
- Mayor psychiatric illness.
- Physical or intellectual limitations to successfully perform neuropsychological evaluation.
- Any other circumstance that may interfere with functional magnetic resonance session
- Abnormal renal function previous to MRI session.
- Pregnant or breastfeeding females or males and females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until six months after the end of the treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Changes in resting state functional activity indexes (rs-fMRI) at 18 months compared to baseline
Secondary endpoints 9
- Changes in resting state functional activity indexes (rs-fMRI) after 18 months of cladribine treatment
- Changes in Image Tensor Diffusion of main cerebral tracts after 18 months of cladribine treatment.
- Changes in volumetric measures from key brain region (corpus callosum, thalamus and hippocampus) after 18 months of cladribine treatment
- The contribution of cortico-cerebellar connectivity to MS cognitive performance after 18 months of cladribine treatment
- Changes in cortical Atrophy Index after 18 months of cladribine treatment after 18 months of cladribine treatment.
- Changes in Brain Activity during processing speed task after 18 months of cladribine treatment.
- Changes in cognitive functioning indexes measured with neuropsychological tests after 18 months of cladribine treatment.
- Changes in emotional/behavioural indexes measured with neuropsychological tests after 18 months of cladribine treatment.
- Changes in clinical neurological status measured with EDSS and ARR after 18 months of cladribine treatment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD5373276 · Product
- Active substance
- Cladribine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 3.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA40 — -
- Marketing authorisation
- EU/1/17/1212/001
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
María Luisa Martínez Ginés
- Sponsor organisation
- María Luisa Martínez Ginés
- Address
- C/ Dr. Esquerdo, 46
- City
- Madrid
- Postcode
- 28007
- Country
- Spain
Scientific contact point
- Organisation
- María Luisa Martínez Ginés
- Contact name
- María Luisa Martínez Ginés
Public contact point
- Organisation
- María Luisa Martínez Ginés
- Contact name
- María Luisa Martínez Ginés
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Expired | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-23 | Spain | Acceptable 2023-06-12
|
2023-06-26 |