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

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, Muscle Fatigue and Muscle Pain in the Postpoliomyelitis Syndrome

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

Study Overview

• Status: Withdrawn
• Conditions: Postpoliomyelitis Syndrome
• Intervention / Treatment: Drug: L-carnitine and piracetam; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • UNIFESP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;
• Ability to understand information about the study and to document the decision about participating in the trial by signing the Informed Consent Form.

Exclusion Criteria:

• 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;
• Anemia (hemoglobin reference range - men 13 to 17 g/dL and women 12 to 15 g/dL);
• High level of glycated hemoglobin (> 7.0%);
• Electrolyte imbalance (hypokalaemia - reference potassium concentration range: 3.5 to 5.6 mmol / L);
• Renal failure (creatinine reference range: 0.70 to 1.50 mg/dL);
• Urinary tract infection;
• Thyroid dysfunction (reference range: free T4: 0.54 to 0.67 mg/dL and TSH reference range: 0.5 to 5.5 μUI/mL) or usual treatment with thyroid hormone supplementation;
• Cardiomyopathy;
• Uncontrolled hypertension;
• Known or suspected autoimmune disease;
• Confirmed pregnancy, or plans to get pregnant during the trial;
• Depression or bipolar affective disorders with moderate to severe episodes within the last twelve months;
• Insulin-dependent diabetes mellitus;
• Treatment with anticoagulant drugs over two weeks (including non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, phenprocoumon, heparin);
• Usual cocaine or alcohol use;
• Any other condition judged by the investigator as a possibility to interfere on the participant's decision to be part of the study or to accomplish investigation procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo PO BID
Experimental: L-carnitine and piracetam	Drug: L-carnitine and piracetam; L-carnitine/piracetam (990mg/810mg) PO BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Muscle Weakness	26 weeks
Changes in fatigue	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in muscle pain	26 weeks
Changes in daytime sleepiness	26 weeks
Changes in quality of life	26 weeks
Changes in daily function	26 weeks
Changes in depressive mood	26 weeks
Changes in oxidative capacity in skeletal muscle	26 weeks
Occurrence of adverse events	26 weeks

Collaborators and Investigators

• Sponsor: Biolab Sanus Farmaceutica
• Investigators: Principal Investigator: Acary Souza Bulle Oliveira, MD, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Primary Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: L-Carnitine; Piracetam; Postpoliomyelitis Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Pain; Neurologic Manifestations; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Central Nervous System Infections; Neurodegenerative Diseases; Neuromuscular Manifestations; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Muscular Disorders, Atrophic; Myelitis; Poliomyelitis; Syndrome; Myalgia; Muscle Weakness; Postpoliomyelitis Syndrome; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents; Nootropic Agents; Piracetam
• Other Study ID Numbers: CAR-PIR.11.01