L-Citrulline in Patients With Post-Polio Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment With L-citrulline in Patients With Post-polio Syndrome - a Randomized Double Blind Placebo Controlled Study

Conditions
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Post-Polio Syndrome

Intervention / Treatment
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* Drug: 15g L-citrulline daily p.o.
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-citrulline<br>15 g L-citrulline p.o. per day (3x 5g) for 24 weeks | Drug: 15g L-citrulline daily p.o.<br> <br> |
| Placebo Comparator: Placebo<br>L-citrulline Placebo 3 times daily p.o. for 24 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of 6 Minute Walking Distance(6MWD) |  | Baseline to week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of motor function measure (MFM) total score |  | Baseline to week 48 | 
| 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 oxidative stress |  | Baseline to week 48 | 
| Change of serum concentrations for markers of nitrosative stress |  | Baseline to week 48 | 
| Change of serum concentrations for markers of mitochondrial related genes |  | Baseline to week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Polio Syndrome, PPS