Postpoliomyelitis Syndrome | 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
Postpoliomyelitis Syndrome research study
What is the primary objective of this study?
This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:L-carnitine and piracetamL-carnitine/piracetam (990mg/810mg) PO BID
Drug:PlaceboPlacebo PO BID
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
L-carnitine and piracetam
Phase: Phase 3
Primary Outcome: Changes in Muscle Weakness
Secondary Outcome: Changes in muscle pain
Study sponsors, principal investigator, and references
Principal Investigator: Acary Souza Bulle Oliveira, MD, PhD
Lead Sponsor: Biolab Sanus Farmaceutica