Postpoliomyelitis SyndromePhase 3NCT01549847
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
A Phase 3 study testing L-carnitine and piracetam in people with Postpoliomyelitis Syndrome, run by Biolab Sanus Farmaceutica at 1 site in Brazil.
Trial summary
This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postpoliomyelitis Syndrome
- What is being tested?
- L-carnitine and piracetam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Start not givento Feb 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.
- Conditions
- Postpoliomyelitis Syndrome
- Being tested
- L-carnitine and piracetam, Placebo
- Keywords
- Postpoliomyelitis Syndrome, Piracetam, L-Carnitine
- Medical subject headings
- Postpoliomyelitis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitine and piracetamDrug
L-carnitine/piracetam (990mg/810mg) PO BID
PlaceboDrug
Placebo PO BID
| Study group | Role | What they receive |
|---|---|---|
| L-carnitine and piracetam | Experimental | Not described Receives: Drug: L-carnitine and piracetam |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Muscle Weakness
Measured: 26 weeks
Changes in fatigue
Measured: 26 weeks
Secondary outcomes (7)
Changes in muscle pain
Measured: 26 weeks
Changes in daytime sleepiness
Measured: 26 weeks
Changes in quality of life
Measured: 26 weeks
Changes in daily function
Measured: 26 weeks
Changes in depressive mood
Measured: 26 weeks
Changes in oxidative capacity in skeletal muscle
Measured: 26 weeks
Occurrence of adverse events
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Primary completionFeb 2013 (estimated)
Why it stopped: Study was not approved by Health Surveillance Agency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpoliomyelitis SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Acary Souza Bulle Oliveira, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549847
- Sponsor's protocol ID
- CAR-PIR.11.01
- Status last verified
- Nov 2015
- First submitted
- 7 Mar 2012
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01549847
- Acronym / sponsor ID
- CAR-PIR.11.01
- Conditions
- Postpoliomyelitis Syndrome
- Keywords
- Postpoliomyelitis Syndrome, Piracetam, L-Carnitine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not approved by Health Surveillance Agency
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Primary completion
- Feb 2013 (estimated)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-carnitine and piracetam | Experimental | Drug: L-carnitine and piracetam |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (18 listed)
- 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%);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitine and piracetamL-carnitine/piracetam (990mg/810mg) PO BID | Drug | L-carnitine and piracetam |
| PlaceboPlacebo PO BID | Drug | Placebo |
Primary outcome
Changes in Muscle Weakness
Time frame: 26 weeks
Changes in fatigue
Time frame: 26 weeks
7 secondary outcomes
Changes in muscle pain
Time frame: 26 weeks
Changes in daytime sleepiness
Time frame: 26 weeks
Changes in quality of life
Time frame: 26 weeks
Changes in daily function
Time frame: 26 weeks
Changes in depressive mood
Time frame: 26 weeks
Changes in oxidative capacity in skeletal muscle
Time frame: 26 weeks
Occurrence of adverse events
Time frame: 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Acary Souza Bulle Oliveira, MD, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-carnitine and piracetam in people with Postpoliomyelitis Syndrome, run by Biolab Sanus Farmaceutica at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Muscle Weakness (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015; AzTrials last refreshed its copy on 31 Oct 2026.