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L-Citrulline in Patients With Post-Polio Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801071
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dirk Fischer, University Hospital, Basel, Switzerland

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).

Condition or disease Intervention/treatment Phase
Post-Polio Syndrome Drug: 15g L-citrulline daily p.o. Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Treatment With L-citrulline in Patients With Post-polio Syndrome - a Randomized Double Blind Placebo Controlled Study"
Actual Study Start Date : June 14, 2016
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : October 5, 2018


Arm Intervention/treatment
Experimental: L-citrulline
15 g L-citrulline p.o. per day (3x 5g) for 24 weeks
Drug: 15g L-citrulline daily p.o.
Placebo Comparator: Placebo
L-citrulline Placebo 3 times daily p.o. for 24 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Mean change of 6 Minute Walking Distance(6MWD) [ Time Frame: Baseline to week 48 ]

Secondary Outcome Measures :
  1. Mean change of motor function measure (MFM) total score [ Time Frame: Baseline to week 48 ]
  2. Change of quantitative muscle MRI (IDEAL-CPMG with T₂ and lipid quantitation and dynamic 31P-MR spectroscopy) [ Time Frame: Baseline to week 48 ]
  3. Change of serum concentrations for markers of muscle necrosis [ Time Frame: Baseline to week 48 ]
  4. Change of serum concentrations for markers of oxidative stress [ Time Frame: Baseline to week 48 ]
  5. Change of serum concentrations for markers of nitrosative stress [ Time Frame: Baseline to week 48 ]
  6. Change of serum concentrations for markers of mitochondrial related genes [ Time Frame: Baseline to week 48 ]

Other Outcome Measures:
  1. Change of disease severity measured by questionnaires [ Time Frame: Baseline to week 48 ]
    Mean change of disease severity as assessed by a combination of the Self-Reported Impairments in Persons With Late Effects of Polio Rating Scale (SIPP-RS), the Inclusion Body Myositis Functional Rating Scale (IBM-FRS) and the World Health Organization Quality Of Life (WHOQOL-BREF)

  2. Changes in Spinal cord MRI from week 48 to week 96 [ Time Frame: week 48 to week 96 ]
    1. Determination of the degree of spinal cord gray and white matter atrophy in PPS patients in comparison to healthy controls and its relationship to physical disability (QMT).
    2. Determination of the degree of motor cortex atrophy in PPS patients compared to healthy controls and its association with spinal cord gray and white matter atrophy in PPS patients.
    3. Determination of the association between spinal cord gray matter atrophy and microstructural alterations as assessed by diffusion tensor imaging.
    4. Test the suitability of the applied, optimized imaging and post-processing methods for longitudinal data.

  3. Changes in brain MRI from week 48 to week 96 [ Time Frame: week 48 to week 96 ]
    1. Determination of the degree of spinal cord gray and white matter atrophy in PPS patients in comparison to healthy controls and its relationship to physical disability (QMT).
    2. Determination of the degree of motor cortex atrophy in PPS patients compared to healthy controls and its association with spinal cord gray and white matter atrophy in PPS patients.
    3. Determination of the association between spinal cord gray matter atrophy and microstructural alterations as assessed by diffusion tensor imaging.
    4. Test the suitability of the applied, optimized imaging and post-processing methods for longitudinal data.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801071


Locations
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Switzerland
University of Basel, Children's Hospital
Basel, Switzerland, 4056
Sponsors and Collaborators
Dirk Fischer
Investigators
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Principal Investigator: Dirk Fischer, Prof. University Children's Hospital Basel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dirk Fischer, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02801071    
Other Study ID Numbers: PPS
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Dirk Fischer, University Hospital, Basel, Switzerland:
Post-Polio Syndrome
PPS
Additional relevant MeSH terms:
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Poliomyelitis
Postpoliomyelitis Syndrome
Syndrome
Disease
Pathologic Processes
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neurodegenerative Diseases