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Study Status: Withdrawn
Recruit Status: Withdrawn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