Postpoliomyelitis Syndrome
Conditions
Keywords
Postpoliomyelitis Syndrome, Piracetam, L-Carnitine
Brief summary
This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.
Interventions
DRUGL-carnitine and piracetam
L-carnitine/piracetam (990mg/810mg) PO BID
DRUGPlacebo
Placebo PO BID
Sponsors
Biolab Sanus Farmaceutica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Muscle Weakness | 26 weeks |
| Changes in fatigue | 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in daily function | 26 weeks |
| Changes in depressive mood | 26 weeks |
| Changes in daytime sleepiness | 26 weeks |
| Occurrence of adverse events | 26 weeks |
| Changes in muscle pain | 26 weeks |
| Changes in oxidative capacity in skeletal muscle | 26 weeks |
| Changes in quality of life | 26 weeks |
Countries
Brazil
Outcome results
None listed