Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome

Phase 1

• Conditions: Chronic Fatigue Syndrome/ Myalgic Encephalopathy, as defined by Canadian Consensus Criteria (2003); MedDRA version: 18.0Level: PTClassification code 10008874Term: Chronic fatigue syndromeSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-004029-41-NO
• Lead Sponsor: Department of Oncology, Haukeland University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-22
• Study Completion: 2020-06-25
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-Patients with chronic fatigue syndrome according to Canadian inclusion criteria (2003).
-Duration of disease at least 24 months.
-Severe, moderate/severe, moderate and moderate/mild ME/CFS may be included.
-Age 18-65 years.
-Signed informed consent.

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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with fatigue, who do not comply with the diagnostic (”Canadian”) criteria for ME/CFS.
-Disease duration < 24 months.
-Patients with mild ME/CFS.
-Patients with very severe ME/CFS (WHO function class IV), who are totally bedridden and in need of care.
-Patients where the workup uncovers other pathology as a possible cause of symptoms.
-Pregnancy or breast feeding. Positive pregnancy test.
-Previous cancer (except basal cell carcinoma of the skin or carcinoma in situ or cervix dysplasia).
-Previous long-term systemic treatment with immunosuppressive agents (Imurel, Sandimmun, Cellcept), except steroid treatments for e.g. obstructive lung disease or other autoimmune diseases like ulcerative colitis.
-Serious endogenous (primary) depression.
-Lack of ability to complete the study including follow-up.
-Reduced kidney function (creatinine > 1,5 x reference area).
-Reduced liver function (bilirubin > 1,5 x reference area, or transaminase > 1,5 x reference area).
-Known HIV-positivity, previous hepatitis B or hepatitis C, or reason to suspect other ongoing and clinically relevant infection.

Study & Design

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