A randomized controlled trial of OSU6162 in treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Phase 1

• Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004357-82-SE
• Lead Sponsor: A. Carlsson Research AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-03
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

A new set of consensus criteria for the diagnosis ME is presented in Journal of Internal Medicine (International Consensus Criteria, ICC, Carruthers et al 2011). These criteria are a updating of the previous used Fukuda and Canadian Criteria. The set of criteria by Fukuda and the ICC will be applied in this study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Unstable therapies are not allowed but stable therapies are allowed. A stable therapy is defined as having started at least 6 months before the study and continued to be unchanged during the study period. Examples of such medications are anti-depressant therapy. Other stable therapies with hypnotics and anxiolytics are also allowed if they are given at doses recommended by the manufacturers. Analgesics such as NSAID, acetyl salicylic acid and paracetamol are permitted as well as stable anti-hypertensive therapy.
•Patients with active substance abuse.
•Pregnant women.
•Women of childbearing age not on contraceptives.
•Uses of acute or chronic medications for other medical conditions are allowed based on clinical judgment. Occasional use of over-the-counter (OTC) medications is allowed at the investigator's discretion. All concomitant medications, whether OTC or prescription, are required to be noted on the Concomitant Medication form.
•Abnormal laboratory parameters judged to be clinical relevant such as Hb, white blood cells count, electrolytes, tests of liver and kidney functions, TSH, T4, B12, folic acid.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified