Clinical trial NCT01549847: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Postpoliomyelitis Syndrome
Keywords: Postpoliomyelitis Syndrome
Piracetam
L-Carnitine
Lead sponsor: Biolab Sanus Farmaceutica
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Changes in Muscle Weakness
timeFrame: 26 weeks
measure: Changes in fatigue
timeFrame: 26 weeks
Secondary outcomes:
measure: Changes in muscle pain
timeFrame: 26 weeks
measure: Changes in daytime sleepiness
timeFrame: 26 weeks
measure: Changes in quality of life
timeFrame: 26 weeks
measure: Changes in daily function
timeFrame: 26 weeks
measure: Changes in depressive mood
timeFrame: 26 weeks
measure: Changes in oxidative capacity in skeletal muscle
timeFrame: 26 weeks
measure: Occurrence of adverse events
timeFrame: 26 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UNIFESP
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Acary Souza Bulle Oliveira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: