HTLV-I-Associated MyelopathyVALPROHAMNCT00519181
Safety and Efficiency Study of Valproic Acid In HAM/TSP
A study testing Valproic Acid in people with HTLV-I-Associated Myelopathy, run by University Hospital Pierre Zobda-Quitman.
Trial summary
Reversible acetylation of the histone tails plays an important role in the control of specific gene expression. Mounting evidence has established that histone deacetylase inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and apoptosis in variety of cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HTLV-I-Associated Myelopathy
- What is being tested?
- Valproic Acid
- Type of treatment
- Pill or oral medicine
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jun 2007
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HAM/TSP patients diagnosed on WHO criteria
- Obtained informed consent.
Who cannot join
- Patients with hepatic or nephrologic disease
- Valproic Acid allergy
- Pregnancy.
About this study
Official title: Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP
Reversible acetylation of the histone tails plays an important role in the control of specific gene expression. Mounting evidence has established that histone deacetylase inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and apoptosis in variety of cancer cells. In a single-center, one year open-label trial, 19 HAM/TSP patients were treated with oral doses of VPA (20mg/Kg/day). Primary end-points were the therapeutic safety and the effect on HTLV-1 proviral load (a significant and sustained decrease was expected). Secondary end-point was the neurological status before and after one-year treatment.
- Conditions
- HTLV-I-Associated Myelopathy
- Being tested
- Valproic Acid
- Keywords
- HTLV, HAM/TSP, VALPROIC ACID, PROVIRAL LOAD
- 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
Valproic acid by oral route (20mg/Kg/day) during one year.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells.
Measured: one year
Secondary outcomes (1)
Neurological outcome.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startMar 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HTLV-I-Associated MyelopathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Pierre Zobda-Quitman
- Sponsor type
- University, hospital or other
- Investigators
- Stephane OLINDO, MD, Principal investigator, University Hospital Pierre Zobda-Quitman, Fort de France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519181
- Sponsor's protocol ID
- PHRC-SO-2006-17
- Acronym
- VALPROHAM
- Status last verified
- Aug 2007
- First submitted
- 20 Aug 2007
- Last updated
- 22 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lezin A, Gillet N, Olindo S, Signate A, Grandvaux N, Verlaeten O, Belrose G, de Carvalho Bittencourt M, Hiscott J, Asquith B, Burny A, Smadja D, Cesaire R, Willems L. Histone deacetylase mediated transcriptional activation reduces proviral loads in HTLV-1 associated myelopathy/tropical spastic paraparesis patients. Blood. 2007 Nov 15;110(10):3722-8. doi: 10.1182/blood-2007-04-085076. Epub 2007 Aug 23.
PubMed 17717136
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP
- ClinicalTrials.gov ID
- NCT00519181
- Acronym / sponsor ID
- VALPROHAM / PHRC-SO-2006-17
- Conditions
- HTLV-I-Associated Myelopathy
- Keywords
- HTLV, HAM/TSP, VALPROIC ACID, PROVIRAL LOAD
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital Pierre Zobda-QuitmanUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Aug 2007 (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.
Reversible acetylation of the histone tails plays an important role in the control of specific gene expression. Mounting evidence has established that histone deacetylase inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and apoptosis in variety of cancer cells. In a single-center, one year open-label trial, 19 HAM/TSP patients were treated with oral doses of VPA (20mg/Kg/day). Primary end-points were the therapeutic safety and the effect on HTLV-1 proviral load (a significant and sustained decrease was expected). Secondary end-point was the neurological status before and after one-year treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HAM/TSP patients diagnosed on WHO criteria
- Obtained informed consent.
Key exclusion criteria (3 listed)
- Patients with hepatic or nephrologic disease
- Valproic Acid allergy
- Pregnancy.
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 AcidValproic acid by oral route (20mg/Kg/day) during one year. | Drug | – |
Primary outcome
Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells.
Time frame: one year
1 secondary outcome
Neurological outcome.
Time frame: one year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2007.
- Derived from this study: PubMed 17717136Lezin A, Gillet N, Olindo S, Signate A, Grandvaux N, Verlaeten O, Belrose G, de Carvalho Bittencourt M, Hiscott J, Asquith B, Burny A, Smadja D, Cesaire R, Willems L. Histone deacetylase mediated transcriptional activation reduces proviral loads in HTLV-1 associated myelopathy/tropical spastic paraparesis patients. Blood. 2007 Nov 15;110(10):3722-8. doi: 10.1182/blood-2007-04-085076. Epub 2007 Aug 23.
Related trials for HTLV-I-Associated Myelopathy
RecruitingObservational study
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Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
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RecruitingPhase 2
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
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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.
Stephane OLINDO, MD principal investigator
University Hospital Pierre Zobda-Quitman, Fort de France
Questions about this trial
What is this clinical trial studying?
A study testing Valproic Acid in people with HTLV-I-Associated Myelopathy, run by University Hospital Pierre Zobda-Quitman.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 22 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00519181, which also lists 1 linked publication.
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 22 Aug 2007.