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

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

Official Title
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A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Therapeutic Effect of the Association of L-carnitine and Piracetam as an Adjuvant Therapy in the Treatment of Weakness, Muscle Fatigue and Muscle Pain in the Postpoliomyelitis Syndrome

Conditions
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Postpoliomyelitis Syndrome

Intervention / Treatment
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* Drug: L-carnitine and piracetam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-carnitine and piracetam<br> | Drug: L-carnitine and piracetam<br>* L-carnitine/piracetam (990mg/810mg) PO BID<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo PO BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Muscle Weakness |  | 26 weeks | 
| Changes in fatigue |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in muscle pain |  | 26 weeks | 
| Changes in daytime sleepiness |  | 26 weeks | 
| Changes in quality of life |  | 26 weeks | 
| Changes in daily function |  | 26 weeks | 
| Changes in depressive mood |  | 26 weeks | 
| Changes in oxidative capacity in skeletal muscle |  | 26 weeks | 
| Occurrence of adverse events |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Piracetam, Postpoliomyelitis Syndrome, L-Carnitine