Study to be conducted only in Italy to evaluate the effect of the treatment with BG00012 on cognitive function in patients with Relapsing Remitting Multiple Sclerosis

• Register: EUCTR
• Last refreshed on: 14 March 2022
• Main ID: EUCTR2013-001422-25-IT
• Date of registration: 17/04/2013
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Italia S.r.l.
• Public title: Study to be conducted only in Italy to evaluate the effect of the treatment with BG00012 on cognitive function in patients with Relapsing Remitting Multiple Sclerosis
• Scientific title: Single country study assessing cognition in Relapsing Remitting Multiple Sclerosis patients treated with BG00012
• Date of first enrolment: 11/06/2013
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001422-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Italy

Contacts

• Name: Medical Affairs
• Affiliation: Biogen Idec Italia

• Name: Medical Affairs
• Affiliation: Biogen Idec Italia

Key inclusion & exclusion criteria

Inclusion criteria:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with local subject privacy regulations.
2. Age =18 years at the time of informed consent.
3. Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005).
4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
5. Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of Gd-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.
6. Subjects of childbearing potential (including female subjects who are not post-menopausal for at least 1 year) must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. For further details of contraceptive requirements for this study, please refer to Section 15.5.3.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
1. Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
2. Severe depression (MADRS score >34) (Montgomery and Asberg 1979)
3. History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
4. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
For a complete list see te protocol


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: dimethyl fumarate [DMF]
Product Code: BG00012
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dimetilfumarato
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: over 2 years

Secondary Objective: The secondary objective of this study is to further assess BG-12 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes. In additional the relationship between cognition and patient reported outcome on depression, fatigue, quality of life, and work and social life activity will be examined.
Additional Assessment:
- any adverse event (including relapses) that could occur throughout the study
- comparison of Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) versus Rao’s Brief Repeatable Battery of Neuropsychological Tests (BRB) together with Stroop Test as a screening tool of cognitive impairment in patients with RRMS.

Main Objective: The primary objective of the study is to assess the BG00012 treatment effect on cognition over 2 year period in RRMS patients

Primary end point(s): Proportion of patients with worsening in CI.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: see above

Secondary end point(s): •Change in cognitive impairment index score (CII) over two years
•Annualized relapse rate (ARR) at year 1 and year 2. Proportion of relapse at year 1 and year 2, and time to relapse over 2 years.
•Proportion of patients with 6-month sustained progression of disability
• Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.
•Change from baseline over two years in patient reported outcomes:
- Depression
- Fatigue- Quality of life- Work/social life activity

Secondary ID(s)

ITA-BGT-12-10389

Source(s) of Monetary Support

Biogen Idec Italia S.r.l.

Ethics review

Status: Approved
Approval date: 13/05/2013
Contact:

Results

• Results available: Yes
• Date Posted: 21/09/2018
• Date Completed: 21/12/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001422-25/results