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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biolab Sanus Farmaceutica
• Treatments: Piracetam

Criteria

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.