Paraparesis Spastic TropicalPhase 3NCT00681980
Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)
A Phase 3 study testing Valproic acid, costicosteroids and valproid acid plus corticosteroids in people with Paraparesis Spastic Tropical, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Is the valproic acid efficacy to treat TSP/HAM Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Paraparesis Spastic Tropical
- What is being tested?
- Valproic acid, costicosteroids and valproid acid plus corticosteroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Dec 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HTLV-1; TSP/HAM fulfill criteria
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Tropical Medicine at Sao Paulo University
São Paulo, São Paulo, 0543903
About this study
Official title: Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil
Is the valproic acid efficacy to treat TSP/HAM
- Conditions
- Paraparesis Spastic Tropical
- Being tested
- Valproic acid, costicosteroids, valproid acid plus corticosteroids
- Keywords
- TSP/HAM, HTLV-1, treatment
- Medical subject headings
- Paraparesis, Tropical Spastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic acidDrug
15 mg/kg/day
costicosteroidsDrug
metypredsolone 1 g/day
valproid acid plus corticosteroidsDrug
valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient
| Study group | Role | What they receive |
|---|---|---|
| A, 2, III | Experimental | Patients with side effects to corticosteroids Receives: Drug: Valproic acid |
| B | Experimental | patient with corticosteroids Receives: Drug: costicosteroids |
| 3 | Experimental | Valproic acid and corticosteroids Receives: Drug: valproid acid plus corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological sacles
Measured: 24 months
Secondary outcomes (1)
Quality of life
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2009
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraparesis Spastic TropicalStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Casseb, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681980
- Sponsor's protocol ID
- 278
- Status last verified
- Dec 2015
- First submitted
- 19 May 2008
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil
- ClinicalTrials.gov ID
- NCT00681980
- Acronym / sponsor ID
- 278
- Conditions
- Paraparesis Spastic Tropical
- Keywords
- TSP/HAM, HTLV-1, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 May 2008 (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.
Is the valproic acid efficacy to treat TSP/HAM
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A, 2, III | Experimental | Drug: Valproic acidPatients with side effects to corticosteroids |
| B | Experimental | Drug: costicosteroidspatient with corticosteroids |
| 3 | Experimental | Drug: valproid acid plus corticosteroidsValproic acid and corticosteroids |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HTLV-1; TSP/HAM fulfill criteria
Key exclusion criteria (1 listed)
- Age <18 years
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 |
|---|---|---|
| Valproic acid15 mg/kg/day | Drug | A, 2, III |
| costicosteroidsmetypredsolone 1 g/day | Drug | B |
| valproid acid plus corticosteroidsvalporid acid 15 mg/kg/day plus corticosteroids 1 g/patient | Drug | 3 |
Primary outcome
Neurological sacles
Time frame: 24 months
1 secondary outcome
Quality of life
Time frame: 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Related InfoLink provided by the sponsor.
Related trials for Paraparesis Spastic Tropical
RecruitingObservational study
Evaluation of Patients With HAM/TSP
HTLV-I Infection, Tropical Spastic Paraparesis
RecruitingPhase 1/2
Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
HAM/TSP
RecruitingPhase 2
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
HTLV-1 Infection, HTLV I Associated Myelopathies
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Valproic acid, costicosteroids and valproid acid plus corticosteroids in people with Paraparesis Spastic Tropical, run by University of Sao Paulo 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurological sacles (time frame: 24 months). 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 3 Dec 2015.