L-Citrulline in Patients With Post-Polio Syndrome

Phase 3

Completed

• Conditions: Post-Polio Syndrome
• Interventions: Drug: 15g L-citrulline daily p.o.; Drug: Placebo

• Registration Number: NCT02801071
• Lead Sponsor: Dirk Fischer

Brief 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).

Detailed Description

This is a single center, randomized, double-blind, placebo controlled study. The study medication consists of L-citrulline, respectively placebo given orally; 5 g L-citrulline or placebo will be given three times daily. The duration of the study is 48 weeks and comprehends one screening and four study visits.

Additionally, in order to investigate whether PPS is associated with an atrophy of spinal cord gray and potentially also white matter as well as motor cortex atrophy, it is planned to offer all trial participants an additional optional spinal cord/brain MRI investigation and a MRI at week 48 and a follow-up one year later together with a clinical and physiotherapy assessment during extension phase. We don't expect Citrulline to affect the spinal cord gray or white and gray matter.

Study Timeline

• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-10
• Study Start: 2016-06-14
• Study First Posted: 2016-06-15
• Primary Completion: 2017-08-15
• Study Completion: 2018-10-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-citrulline	15g L-citrulline daily p.o.	15 g L-citrulline p.o. per day (3x 5g) for 24 weeks
Placebo	Placebo	L-citrulline Placebo 3 times daily p.o. for 24 weeks

Primary Outcome Measures

Name	Time	Method
Mean change of 6 Minute Walking Distance(6MWD)	Baseline to week 48

Secondary Outcome Measures

Name	Time	Method
Change of quantitative muscle MRI (IDEAL-CPMG with T₂ and lipid quantitation and dynamic 31P-MR spectroscopy)	Baseline to week 48
Change of serum concentrations for markers of muscle necrosis	Baseline to week 48
Change of serum concentrations for markers of nitrosative stress	Baseline to week 48
Mean change of motor function measure (MFM) total score	Baseline to week 48
Change of serum concentrations for markers of oxidative stress	Baseline to week 48
Change of serum concentrations for markers of mitochondrial related genes	Baseline to week 48

Trial Locations

Locations (1)

University of Basel, Children's Hospital; 🇨🇭 Basel, Switzerland