Attention Deficit Hyperactivity DisorderPhase 1NCT00995085
Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects
A Phase 1 study testing Extended Release Metadoxine in people with Attention Deficit Hyperactivity Disorder, run by Alcobra Ltd. at 1 site in Israel.
Trial summary
This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Extended Release Metadoxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-45
- diagnosed as ADHD
Who cannot join
- PDD patients
- head injured patients
- patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin B
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Study of Metadoxine SR Formulation in ADHD Subjects
This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration.
Read the detailed description
Primary outcome measure is the safety and tolerability of study drug after a single dosing.
Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population.
Exploratory outcome measures include:
- TOVA measures like response time , variability, omissions etc.
- Subtests from Wechsler: digit memory, digit-number signs etc
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Extended Release Metadoxine
- Keywords
- ADHD, ADD, TOVA, METADOXINE
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Release MetadoxineDrug
Also called Metadoxine, Metadoxil
one oral 1400mg dose (2 tablets)
| Study group | Role | What they receive |
|---|---|---|
| Metadoxine SR | Experimental | Metadoxine is a pyrolate salt of Pyridoxine Receives: Drug: Extended Release Metadoxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug
Measured: 24 hours after drug adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcobra Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iris Manor, MD, Principal investigator, Geha MC, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995085
- Sponsor's protocol ID
- 0012-09-GEH
- Status last verified
- Jun 2011
- First submitted
- 13 Oct 2009
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Metadoxine SR Formulation in ADHD Subjects
- ClinicalTrials.gov ID
- NCT00995085
- Acronym / sponsor ID
- 0012-09-GEH
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, ADD, TOVA, METADOXINE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Alcobra Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Posted 6 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration.
Detailed description
Primary outcome measure is the safety and tolerability of study drug after a single dosing.
Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population.
Exploratory outcome measures include:
- TOVA measures like response time , variability, omissions etc.
- Subtests from Wechsler: digit memory, digit-number signs etc
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metadoxine SR | Experimental | Drug: Extended Release MetadoxineMetadoxine is a pyrolate salt of Pyridoxine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18-45
- diagnosed as ADHD
Key exclusion criteria (3 listed)
- PDD patients
- head injured patients
- patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin B
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 |
|---|---|---|
| Extended Release MetadoxineAlso: Metadoxine, Metadoxilone oral 1400mg dose (2 tablets) | Drug | Metadoxine SR |
Primary outcome
Safety and Tolerability
Time frame: 24 hours after drug adminstration
Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Iris Manor, MD principal investigator
Geha MC, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Extended Release Metadoxine in people with Attention Deficit Hyperactivity Disorder, run by Alcobra Ltd. at 1 site in Israel.
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: finished, as of the sponsor's last update on 13 Mar 2017. 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 Israel. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability (time frame: 24 hours after drug adminstration). 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 13 Mar 2017.