A Randomized, Double Blind, Placebo Controlled Trial L-carnitine and Piracetam in the Treatment of Weakness, Muscle Fatigue and Muscle Pain in the Postpoliomyelitis Syndrome

What Was Tested

The trial (phase 3) is built around L-Carnitine.

This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.

It had two arms (groups): L-carnitine and piracetam (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with Postpoliomyelitis Syndrome diagnosis confirmed over a year;. Electromyography test compatible with poliomyelitis;. Preserved ability to swallow medication;. Oral communication ability preserved;. Preserved ability to perform pedaling test in at least one lower limb affected by Postpoliomyelitis Syndrome;.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: history of intolerance to l-carnitine or piracetam;; treatment with l-carnitine during the past 3 months;; treatment with piracetam or any other nootropics pyrrolidone derivatives, during the past three months;.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes in Muscle Weakness (time frame: 26 weeks). Changes in fatigue (time frame: 26 weeks).

It also tracked 7 secondary outcomes, for example Changes in muscle pain, Changes in daytime sleepiness, Changes in quality of life, Changes in daily function, Changes in depressive mood and Changes in oxidative capacity in skeletal muscle.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.