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

Last updated: November 16, 2015
Sponsor: Biolab Sanus Farmaceutica
Overall Status: Trial Not Available

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Muscle Pain

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01549847
CAR-PIR.11.01
  • Ages 18-60
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 byPostpoliomyelitis Syndrome;

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

Exclusion

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 thepast 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 referencerange: 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 thelast twelve months;

  • Insulin-dependent diabetes mellitus;

  • Treatment with anticoagulant drugs over two weeks (including non-steroidalanti-inflammatory drugs (NSAIDs), warfarin, phenprocoumon, heparin);

  • Usual cocaine or alcohol use;

  • Any other condition judged by the investigator as a possibility to interfere on theparticipant's decision to be part of the study or to accomplish investigationprocedures.

Study Design

Study Start date:
Estimated Completion Date:

Connect with a study center

  • UNIFESP

    São Paulo, SP
    Brazil

    Site Not Available

  • UNIFESP

    São Paulo, SP
    Brazil

    Site Not Available

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