Clinical Trial: 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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Therapeutic Effect of the Association of L-carnitine and Piracetam as an Adjuvant Therapy in the Treatment of Weakness,

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

Detailed Summary:
Sponsor: Biolab Sanus Farmaceutica

Current Primary Outcome:

  • Changes in Muscle Weakness [ Time Frame: 26 weeks ]
  • Changes in fatigue [ Time Frame: 26 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in muscle pain [ Time Frame: 26 weeks ]
  • Changes in daytime sleepiness [ Time Frame: 26 weeks ]
  • Changes in quality of life [ Time Frame: 26 weeks ]
  • Changes in daily function [ Time Frame: 26 weeks ]
  • Changes in depressive mood [ Time Frame: 26 weeks ]
  • Changes in oxidative capacity in skeletal muscle [ Time Frame: 26 weeks ]
  • Occurrence of adverse events [ Time Frame: 26 weeks ]


Original Secondary Outcome: Same as current

Information By: Biolab Sanus Farmaceutica

Dates:
Date Received: March 7, 2012
Date Started:
Date Completion:
Last Updated: November 16, 2015
Last Verified: November 2015