Tecfidera and MRI for Brain Energy in MS

Multiple Sclerosis Clinical Trial

Official title:

Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02644083
• Other study ID #: IRB 11364
• Status: Terminated
• Start date: February 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS. The investigators will assess mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosis of MS by 2010 McDonald criteria

• Relapsing clinical course

• Ages 18-55

• Laboratory values that allow initiation of dimethyl fumarate (Tecfidera)

Exclusion Criteria:

• Systemic disease associated with cerebrovascular disease (e.g. diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease)

• Treatment with corticosteroids or disease-modifying therapies (interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide) within 30 days of the first baseline MRI scan.

• Treatment at any time with mitoxantrone, cyclophosphamide, or any other long acting immunosuppressant

• Prior treatment of greater than 1 month at any time with DMF

• Inability to tolerate MRI procedures

• Pregnant/breastfeeding

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Dimethyl fumarate

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in fatigue	as assessed by Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFIS),	baseline and 6 months of treatment with DMF
Other	Changes in fatigue	as assessed by Modified Fatigue Impact Scale (MFIS),	baseline and 6 months of treatment with DMF
Other	Changes in cognition	as assessed by the symbol digit modalities test (SDMT)	baseline and 6 months of treatment with DMF
Primary	Changes in phosphocreatine (PCr) in cerebral grey matter	PCr levels evaluated by magnetic resonance spectroscopy	baseline and 6 months of treatment with Dimethyl Fumarate (DMF)
Secondary	Changes in ATP in normal appearing white matter (NAWM)	ATP levels evaluated by magnetic resonance spectroscopy	baseline and 6 months of treatment with Dimethyl Fumarate