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
Primary Purpose
Postpoliomyelitis Syndrome
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
L-carnitine and piracetam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postpoliomyelitis Syndrome focused on measuring Postpoliomyelitis Syndrome, Piracetam, L-Carnitine
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.
Sites / Locations
- UNIFESP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
L-carnitine and piracetam
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Changes in Muscle Weakness
Changes in fatigue
Secondary Outcome Measures
Changes in muscle pain
Changes in daytime sleepiness
Changes in quality of life
Changes in daily function
Changes in depressive mood
Changes in oxidative capacity in skeletal muscle
Occurrence of adverse events
Full Information
NCT ID
NCT01549847
First Posted
March 7, 2012
Last Updated
November 16, 2015
Sponsor
Biolab Sanus Farmaceutica
1. Study Identification
Unique Protocol Identification Number
NCT01549847
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not approved by Health Surveillance Agency
Study Start Date
undefined (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biolab Sanus Farmaceutica
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpoliomyelitis Syndrome
Keywords
Postpoliomyelitis Syndrome, Piracetam, L-Carnitine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-carnitine and piracetam
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
L-carnitine and piracetam
Intervention Description
L-carnitine/piracetam (990mg/810mg) PO BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo PO BID
Primary Outcome Measure Information:
Title
Changes in Muscle Weakness
Time Frame
26 weeks
Title
Changes in fatigue
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Changes in muscle pain
Time Frame
26 weeks
Title
Changes in daytime sleepiness
Time Frame
26 weeks
Title
Changes in quality of life
Time Frame
26 weeks
Title
Changes in daily function
Time Frame
26 weeks
Title
Changes in depressive mood
Time Frame
26 weeks
Title
Changes in oxidative capacity in skeletal muscle
Time Frame
26 weeks
Title
Occurrence of adverse events
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Acary Souza Bulle Oliveira, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNIFESP
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
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
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