L-Citrulline in Patients With Post-Polio Syndrome

• Status: Completed
• Trial end date: 2018-10-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to show that the intake of L-citrulline improves muscle function in patients with Post-Polio Syndrome (PPS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dirk Fischer

Criteria

Inclusion Criteria:

• Prior paralytic poliomyelitis with evidence of motor neuron loss

• A period of partial or complete functional recovery after acute paralytic Poliomyelitis

• Slowly progressive and persistent new muscle weakness or decreased endurance, with or without generalized fatigue, muscle atrophy, or muscle and joint pain. Symptoms that persist for at least a year

• Exclusion of other neuromuscular, medical and skeletal abnormalities as causes of symptoms

• Patients older than 18 years at time of Screening

• ambulant

• ability to walk 150m in the 6 min. Walking distance (6MWD)

• females of childbearing potential willing to use contraceptive during the study

Exclusion Criteria:

• Previous (3 months or less) or concomitant participation in any other therapeutic trial

• Use of L-citrulline or L-arginine within the last 3 months

• Known individual hypersensitivity to L-citrulline

• Known or suspected malignancy

• Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator

• Pregnant or breast-feeding women

• Severe renal failure (calculated glomerular filtration rate (GFR) < 30 ml/min)