StrokePhase 2TIERSNCT00721825
Study of NeuroAid In Enhancing Recovery After Stroke
A Phase 2 study testing Neuroaid in people with Stroke and Cerebral Infarction, run by Moleac Pte Ltd. at 1 site in Singapore.
Trial summary
TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke, Cerebral Infarction
- What is being tested?
- Neuroaid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2008to Jul 2008
- Phase
- Phase 2
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject had cerebral infarction confirmed by Computed Tomography (CT scan or Magnetic Resonance Imaging (MRI) imaging
- Presents within 1 month after stroke onset
- Presents with motor power of from grade 1 - 4/5 in at least one limb
- Has a pre-stroke modified Rankin score ≤ 1.
- Age between 21 and 80 years old
- Female subjects are eligible to participate in the trial if they are of non childbearing potential (hysterectomy or post-menopausal)
- Subject or legally acceptable representative is willing and able to provide written informed consent
- Subject and carer are willing and able to comply with investigational drug administration schedule.
Who cannot join
- Subject has received thrombolysis
- Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
- Subject has definite indication for full-dose or long-term anticoagulation therapy
- Subject has other significant non-ischemic brain lesion which could affect function disability
- Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine >200 μmol/L, if known), cirrhosis, severe dementia or psychosis
- Subject has a history of previous stroke/s
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- Subject has participated in another clinical trial within the last three months
- Subject has aphasia or any other cognitive disabilities which prevent cooperation with study instructions
- Subject has dense hemiplegia (grade 0 motor power)
- Subject has haemoglobin level of <10mg/dl on admission
- Subject has a history of craniotomy or seizures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blinded, Placebo-Controlled, Randomized Phase II Pilot Study to Investigate the Potential Efficacy of a Traditional Chinese Medicine NeuroAid In Enhancing Recovery After Stroke (TIERS)
TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.
- Conditions
- Stroke, Cerebral Infarction
- Being tested
- Neuroaid, Neuroaid matched Placebo
- Keywords
- Stroke, Cerebral infarct, Rehabilitation, Double blind Randomized, Placebo controlled, Traditional Chinese Medicine, Neuroaid
- Medical subject headings
- Stroke, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroaidDrug
Neuroaid capsules, 4 capsules, three times per day, during one month
Neuroaid matched PlaceboDrug
Neuroaid matched placebo 4 capsules three times per day during one month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Neuroaid Receives: Drug: Neuroaid |
| 2 | Placebo comparator | Neuroaid matched placebo Receives: Drug: Neuroaid matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment
Measured: 4 weeks
Secondary outcomes (3)
Functional Independence Measure (FIM) scale
Measured: 4 weeks and 8 weeks
Fugl-Meyer subscores
Measured: 4 weeks and 8 weeks
NIHSS and NIHSS subscores
Measured: 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moleac Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Keng He Kong, MD, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721825
- Sponsor's protocol ID
- Moleac
- Acronym
- TIERS
- Status last verified
- Jul 2008
- First submitted
- 22 Jul 2008
- Last updated
- 24 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Placebo-Controlled, Randomized Phase II Pilot Study to Investigate the Potential Efficacy of a Traditional Chinese Medicine NeuroAid In Enhancing Recovery After Stroke (TIERS)
- ClinicalTrials.gov ID
- NCT00721825
- Acronym / sponsor ID
- TIERS / Moleac
- Conditions
- Stroke, Cerebral Infarction
- Keywords
- Stroke, Cerebral infarct, Rehabilitation, Double blind Randomized, Placebo controlled, Traditional Chinese Medicine, Neuroaid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Moleac Pte Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 24 Jul 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.
TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.
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 |
|---|---|---|
| 1 | Active comparator | Drug: NeuroaidNeuroaid |
| 2 | Placebo comparator | Drug: Neuroaid matched PlaceboNeuroaid matched placebo |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject had cerebral infarction confirmed by Computed Tomography (CT scan or Magnetic Resonance Imaging (MRI) imaging
- Presents within 1 month after stroke onset
- Presents with motor power of from grade 1 - 4/5 in at least one limb
- Has a pre-stroke modified Rankin score ≤ 1.
- Age between 21 and 80 years old
Key exclusion criteria (11 listed)
- Subject has received thrombolysis
- Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
- Subject has definite indication for full-dose or long-term anticoagulation therapy
- Subject has other significant non-ischemic brain lesion which could affect function disability
- Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine >200 μmol/L, if known), cirrhosis, severe dementia or psychosis
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 |
|---|---|---|
| NeuroaidNeuroaid capsules, 4 capsules, three times per day, during one month | Drug | 1 |
| Neuroaid matched PlaceboNeuroaid matched placebo 4 capsules three times per day during one month | Drug | 2 |
Primary outcome
Fugl-Meyer assessment
Time frame: 4 weeks
3 secondary outcomes
Functional Independence Measure (FIM) scale
Time frame: 4 weeks and 8 weeks
Fugl-Meyer subscores
Time frame: 4 weeks and 8 weeks
NIHSS and NIHSS subscores
Time frame: 4 weeks and 8 weeks
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 24 Jul 2008.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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.
Keng He Kong, MD principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neuroaid in people with Stroke and Cerebral Infarction, run by Moleac Pte Ltd. at 1 site in Singapore.
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 8 inclusion and 11 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 24 Jul 2008. 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 Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Fugl-Meyer assessment (time frame: 4 weeks). 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 24 Jul 2008.