Schedule of enrolment, intervention and assessments. The study schedule will be the same in step 1 and in step 2 and it includes the following visits and clinical examinations. Patients with chronic SCI will undergo a screening period (v1) with a maximum duration of 2 weeks and then they will be randomized to one of the two groups (v2): riluzole twice daily or placebo twice daily for a 2 weeks period. Three follow up visits are planned: at day3 after the beginning of treatment for PK analysis (v3), and at the end of the 2 weeks treatment period (v4) and one week after withdrawal of study medication (v5).</p
ObjectivesSPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (C...
Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence t...
*Standard protocol items recommendations for Interventional Trials (SPIRIT) diagram [13]. CT compute...
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT); schedule of enrolment, ...
Standard protocol items: Recommendations for interventional trials (SPIRIT) recommended content for ...
Standard protocol items: Recommendations for interventional trials (SPIRIT) recommended content for ...
SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials. (DOCX)</p
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) timeline of measurements...
Note: -t1, Eligibility screen, Informed consent; t1, baseline assessment; t2, post 8-week interventi...
1RM = one repetition maximum; DXA = dual-energy X-ray absorptiometry; CK = creatine kinase; IL-6 = i...
Contains fulltext : 237212.pdf (Publisher’s version ) (Open Access)BACKGROUND: Pro...
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, an...
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, an...
SPIRIT (Standard protocol items: Recommendations for interventional trials)[30].</p
Checklist of the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) 2013.</p
ObjectivesSPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (C...
Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence t...
*Standard protocol items recommendations for Interventional Trials (SPIRIT) diagram [13]. CT compute...
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT); schedule of enrolment, ...
Standard protocol items: Recommendations for interventional trials (SPIRIT) recommended content for ...
Standard protocol items: Recommendations for interventional trials (SPIRIT) recommended content for ...
SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials. (DOCX)</p
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) timeline of measurements...
Note: -t1, Eligibility screen, Informed consent; t1, baseline assessment; t2, post 8-week interventi...
1RM = one repetition maximum; DXA = dual-energy X-ray absorptiometry; CK = creatine kinase; IL-6 = i...
Contains fulltext : 237212.pdf (Publisher’s version ) (Open Access)BACKGROUND: Pro...
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, an...
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, an...
SPIRIT (Standard protocol items: Recommendations for interventional trials)[30].</p
Checklist of the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) 2013.</p
ObjectivesSPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (C...
Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence t...
*Standard protocol items recommendations for Interventional Trials (SPIRIT) diagram [13]. CT compute...