A Randomized, Double Blind, Placebo Controlled Trial L-carnitine and Piracetam in the Treatment o… (NCT01549847) | Clinical Trial Compass
WithdrawnPhase 3
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
Stopped: Study was not approved by Health Surveillance Agency
Brazil0
Plain-language summary
This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
* Insul…