Clinical Trial Details
Braintumor Website

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NCT01910259 : MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial
PhasePhase 2
AgesMin: 25 Years Max: 65 Years
Inclusion Criteria:

- Confirmed diagnosis of SPMS. Steady progression rather than relapse must be the major
cause of increasing disability in the preceding 2 years. Evidence of progression,
either an increase of at least one point in EDSS or clinical documentation of
increasing disability in patient notes

- Expanded Disability Status Scale (EDSS) 4.0-6.5

- Aged 25 to 65 inclusive

- Women and men with partners of childbearing potential must be using an appropriate
method of contraception to avoid any unlikely teratogenic effects of the 3 drugs from
time of consent, to 6 weeks after treatment inclusive

- Women must have a negative pregnancy test within 7 days prior to the baseline visit
unless not of child bearing potential (e.g. have undergone a hysterectomy, bilateral
tubal ligation or bilateral oophorectomy or they are postmenopausal)

- Willing and able to comply with the trial protocol (e.g. can tolerate MRI and fulfils
the requirements for MRI, e.g. not fitted with pacemakers or permanent hearing aids),
ability to understand and complete questionnaires

- Written informed consent provided

Exclusion Criteria:

- Pregnancy or breast feeding patients

- Baseline MRI scan not of adequate quality for analysis (e.g. too much movement

- Significant organ co-morbidity (e.g. malignancy or renal or hepatic failure)

- Relapse within 3 months of baseline visit

- Patients who have been treated with iv or oral steroids within 3 months of baseline
visit (these patients can undergo future screening visits once the 3 month window has

- Commencement of fampridine within 6 months of baseline visit

- Use of immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine) or disease
modifying treatments (?-interferons, glatiramer) within 6 months of baseline visit

- Use of fingolimod/fumarate/teriflunomide/laquinomod/or other experimental disease
modifying treatment (including research of an investigational medicinal product)
within 12 months of baseline visit

- Use of mitoxantrone/ natalizumab/ alemtuzumab/ daclizumab if treated within 12 months
of baseline visit

- Primary progressive MS

- Relapsing-remitting MS

- Known hypersensitivity to the active substances and their excipients to any of the
active drugs for this trial

- Use of: lithium, chlorpropamide, triamterene and spironolactone within 6 months of
the baseline visit

- Current use of potassium supplements

- Current use of tamoxifen

- Current use of herbal treatments containing St. John's Wort

- Significant signs of depression

- Use of an SSRI within 6 months of the baseline visit

- Use of monoamine oxidase inhibitors, phenytoin, L-tryptophan) and/or neuroleptic
drugs within 6 months of the baseline visit

- A Beck Depression Index score of 19 or higher

- Bipolar disorder

- Receiving or previously received Electro-Convulsive Therapy

- Epilepsy/seizures

- Glaucoma

- Patients with a history of bleeding disorders or currently on anticoagulants

- Routine screening blood values (LFT) >/ 3 x upper limit of normal (ULN) of site
reference ranges (ALT/AST, bilirubin, ?GT)

- Potassium <2.8mmol/l or >5.5mmol/l

- Sodium <125mmol/l

- Creatinine >130µmol/l

- WBCs <3 x 109/l

- Lymphocytes <0.8 x 109/l

- Neutrophil count <1.0 x 109 /l

- Platelet count <90 x 109 /l

- Haemoglobin <80g/l
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