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

Biolab Pharma

Status and phase

Withdrawn

Phase 3

Conditions

Postpoliomyelitis Syndrome

Treatments

Drug: Placebo

Drug: L-carnitine and piracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01549847

CAR-PIR.11.01

Details and patient eligibility

About

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

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.