NCT02801071

L-Citrulline in Patients With Post-Polio Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Dirk Fischer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Polio Syndrome

Interventions

Type	Name	Description
DRUG	15g L-citrulline daily p.o.
DRUG	Placebo

Timeline

• Start date: 2016-06-14
• Primary completion: 2017-08-15
• Completion: 2018-10-05
• First posted: 2016-06-15
• Last updated: 2019-01-23

Locations

1 site across 1 country: Switzerland