EUCTR2019-000099-41-GB
Active, not recruiting
Phase 1
Motor Neurone Disease Systematic Multi-arm Adaptive Randomised Trial (MND-SMART) - MND-SMART
niversity of Edinburgh0 sites750 target enrollmentJuly 25, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Motor Neurone Disease
- Sponsor
- niversity of Edinburgh
- Enrollment
- 750
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •·Confirmed diagnosis of MND (including the following subtypes: ALS by El Escorial Criteria (possible, probable, and definite), Primary Lateral Sclerosis, and Progressive Muscular Atrophy)
- •·Women of childbearing potential according to CTFG guidelines (http://www.hma.eu/fileadmin/dateien/Human\_Medicines/01\-About\_HMA/Working\_Groups/CTFG/2014\_09\_HMA\_CTFG\_Contraception.pdf) must have a negative pregnancy test within 7 days prior to the baseline visit
- •·Women of childbearing potential and fertile men (according to CTFG guidelines) must be using an appropriate method of contraception to avoid any unlikely teratogenic effects of the selected drugs from time of consent, to 4 weeks after treatment inclusive
- •·Willing and able to comply with the trial protocol and ability to understand and complete questionnaires
- •·Written informed consent (this can be signed by a proxy in the case of limb dysfunction)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 375
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Patients diagnosed with Fronto\-temporal Dementia (FTD\-MND) or any other significant psychiatric disorder that prevents informed consent being given.
- •Patients in the manic phase of bipolar disorder.
- •Alcoholism (self\-reported)
- •Active suicide ideation assessed using the Columbia\-Suicide Severity Rating Scale
- •On concurrent investigational medication (including biological therapy)
- •Known hypersensitivity, including hereditary fructose intolerance, or adverse reaction to the active substances and their excipients or any past medical history contraindicating use of any of the IMPs
- •Pregnancy or breast\-feeding females
- •If ALT, ALP, bilirubin or GGT \>3 times the upper limit of normal.
- •If creatinine clearance (creatinine clearance or eGFR) \<30 ml/min.
- •If Serum free T4 \>25pmol/l or TSH \<0\.2mU/l
Outcomes
Primary Outcomes
Not specified
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