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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01549847
Recruitment Status : Withdrawn (Study was not approved by Health Surveillance Agency)
First Posted : March 9, 2012
Last Update Posted : November 17, 2015
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica

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.

Condition or disease Intervention/treatment Phase
Postpoliomyelitis Syndrome Drug: L-carnitine and piracetam Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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, Muscle Fatigue and Muscle Pain in the Postpoliomyelitis Syndrome
Estimated Primary Completion Date : February 2013

Arm Intervention/treatment
Experimental: L-carnitine and piracetam Drug: L-carnitine and piracetam
L-carnitine/piracetam (990mg/810mg) PO BID

Placebo Comparator: Placebo Drug: Placebo
Placebo PO BID

Primary Outcome Measures :
  1. Changes in Muscle Weakness [ Time Frame: 26 weeks ]
  2. Changes in fatigue [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Changes in muscle pain [ Time Frame: 26 weeks ]
  2. Changes in daytime sleepiness [ Time Frame: 26 weeks ]
  3. Changes in quality of life [ Time Frame: 26 weeks ]
  4. Changes in daily function [ Time Frame: 26 weeks ]
  5. Changes in depressive mood [ Time Frame: 26 weeks ]
  6. Changes in oxidative capacity in skeletal muscle [ Time Frame: 26 weeks ]
  7. Occurrence of adverse events [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01549847

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São Paulo, SP, Brazil
Sponsors and Collaborators
Biolab Sanus Farmaceutica
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Principal Investigator: Acary Souza Bulle Oliveira, MD, PhD Federal University of São Paulo
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Responsible Party: Biolab Sanus Farmaceutica Identifier: NCT01549847    
Other Study ID Numbers: CAR-PIR.11.01
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Biolab Sanus Farmaceutica:
Postpoliomyelitis Syndrome
Additional relevant MeSH terms:
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Postpoliomyelitis Syndrome
Muscle Weakness
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Neurologic Manifestations
Neuromuscular Manifestations
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Muscular Disorders, Atrophic
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Neurodegenerative Diseases
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs