NCT02801071

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

June 14, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

June 6, 2016

Last Update Submit

January 21, 2019

Conditions

Post-Polio Syndrome

Keywords

Post-Polio SyndromePPS

Outcome Measures

Primary Outcomes (1)

  • Mean change of 6 Minute Walking Distance(6MWD)

    Baseline to week 48

Secondary Outcomes (6)

  • Mean change of motor function measure (MFM) total score

    Baseline to week 48

  • Change of quantitative muscle MRI (IDEAL-CPMG with Tâ‚‚ 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

  • +1 more secondary outcomes

Other Outcomes (3)

  • Change of disease severity measured by questionnaires

    Baseline to week 48

  • Changes in Spinal cord MRI from week 48 to week 96

    week 48 to week 96

  • Changes in brain MRI from week 48 to week 96

    week 48 to week 96

Study Arms (2)

L-citrulline

EXPERIMENTAL

15 g L-citrulline p.o. per day (3x 5g) for 24 weeks

Drug: 15g L-citrulline daily p.o.

Placebo

PLACEBO COMPARATOR

L-citrulline Placebo 3 times daily p.o. for 24 weeks

Drug: Placebo

Interventions

15g L-citrulline daily p.o.DRUG
L-citrulline
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel, Children's Hospital

Basel, 4056, Switzerland

Location

Related Publications (2)

  • Gocheva V, Hafner P, Orsini AL, Schmidt S, Schaedelin S, Rueedi N, Rubino-Nacht D, Weber P, Fischer D. Health-related quality of life, self-reported impairments and activities of daily living in relation to muscle function in post-polio syndrome. J Patient Rep Outcomes. 2020 Jul 16;4(1):59. doi: 10.1186/s41687-020-00226-5.

    PMID: 32676980DERIVED

  • Schmidt S, Gocheva V, Zumbrunn T, Rubino-Nacht D, Bonati U, Fischer D, Hafner P. Treatment with L-citrulline in patients with post-polio syndrome: study protocol for a single-center, randomised, placebo-controlled, double-blind trial. Trials. 2017 Mar 9;18(1):116. doi: 10.1186/s13063-017-1829-3.

    PMID: 28274276DERIVED

MeSH Terms

Conditions

Postpoliomyelitis Syndrome

Condition Hierarchy (Ancestors)

PoliomyelitisMyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeurodegenerative DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Study Officials

  • Dirk Fischer, Prof.

    University Children's Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 15, 2016

Study Start

June 14, 2016

Primary Completion

August 15, 2017

Study Completion

October 5, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

CH(1)