EUCTR2019-000099-41-GBActive, not recruitingPhase 1
Motor Neurone Disease Systematic Multi-arm Adaptive Randomised Trial (MND-SMART) - MND-SMART
niversity of Edinburgh0 sites750 target enrollmentStarted: July 25, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 750
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •F.1.3.1 Number of subjects for this age range 375
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
- •If corrected QT interval on 12 lead ECG >450 ms
- •Patient’s diagnosed with ventricular arrhythmias, heart block or in the immediate recovery period after myocardial infarction (< 6 weeks).
- •Already taking any of the IMPs in this protocol
- •Patient’s contraindicated to any of the IMPs
- •Taking a medication that interacts with the active substances and their excipients, including but not limited to; Dextromethorphan, Amantadine; Ketamine, Monoamine-oxidase inhibitors ((MAOIs), Rasagiline, Selegiline, Safinamide, Tranylcypromine, Phenelzine, Isocarboxazid, Moclobemide).
Investigators
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