StrokePhase 2NCT00331721
Tolerability of Enecadin (INN) in Acute Ischemic Stroke Trial - TEST
A Phase 2 study testing Enecadin in people with Stroke, run by PAION Deutschland GmbH at 26 sites in 3 countries.
Trial summary
The main objective of this study is to investigate the tolerability of enecadin in patients with acute ischemic stroke. Furthermore, the pharmacokinetics of enecadin in both male and female patients with acute ischemic stroke will be assessed. Efficacy trends will be evaluated up to day 30 post stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Enecadin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 26 sitesin 3 countries
- Study dates
- May 2006to May 2009
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute ischemic stroke (scoring 3-20 on the National Institutes of Health Stroke Scale [NIHSS]) with level of consciousness score: 0 or 1 (conscious patients) are eligible to be treated within 9 hours of onset of stroke symptoms.
- For female patients: post-menopausal or surgically sterile (post-menopausal: age ≥55 years and last menses ≥3 years ago).
Who cannot join
- Participation in any investigational study in the previous 30 days.
- Patients unable to understand trial related information.
- History or evidence of severe heart diseases further specified in the protocol.
- History or evidence of additional diseases or results of baseline visit as specified in the protocol.
- Use of concomitant and prior medications as defined in the protocol.
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
Germany21 sites
Investigational Site
Aachen
Investigational Site
Bad Neustadt an der Saale
Investigational Site
Bergisch Gladbach
Investigational Site
Berlin
Investigational Site
Bochum
Investigational Site
Dortmund
Investigational Site
Dresden
Investigational Site
Erlangen
Investigational Site
Frankfurt
Investigational Site
Freiburg im Breisgau
Investigational Site
Hamburg
Investigational Site
Hanover
University of Heidelberg
Heidelberg
Investigational Site
Ingolstadt
Investigational Site
Leipzig
Investigational Site
Magdeburg
Investigational Site
Minden
Investigational Site
Munich
Investigational Site
Nuremberg
Investigational Site
Remscheid
Investigational Site
Wiesbaden
Belgium3 sites
Investigational Site
Antwerp
Investigational Site
Bruges
Investigational Site
Leuven
About this study
Official title: A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalating Parallel-Group Study to Investigate the Tolerability of Enecadin (INN) in Acute Ischemic Stroke
The main objective of this study is to investigate the tolerability of enecadin in patients with acute ischemic stroke. Furthermore, the pharmacokinetics of enecadin in both male and female patients with acute ischemic stroke will be assessed. Efficacy trends will be evaluated up to day 30 post stroke.
Read the detailed description
In the acute stage of ischemic stroke, an ischemic core characterized by a marked decrease in blood flow is present, leading to irreversible neuronal damage at an early stage. Around the boundary of the ischemic core, there is a region called ischemic penumbra in which functional recovery is possible after recirculation of blood flow within several hours after the onset, even though the blood flow is markedly decreased. Prevention of nerve cell death in the ischemic penumbra by neuroprotective therapy should greatly improve outcome and prognosis of acute ischemic stroke.
- Conditions
- Stroke
- Being tested
- Enecadin, Placebo
- Keywords
- Acute Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnecadinDrug
Dose escalating
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Enecadin Receives: Drug: Enecadin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters, Pharmacokinetics & trends of efficacy
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Why it stopped: Scientific data called into question the viability of the substance class
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAION Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter A Ringleb, Dr., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331721
- Sponsor's protocol ID
- PN06-CLD-01001
- Status last verified
- May 2008
- First submitted
- 30 May 2006
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalating Parallel-Group Study to Investigate the Tolerability of Enecadin (INN) in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00331721
- Acronym / sponsor ID
- PN06-CLD-01001
- Conditions
- Stroke
- Keywords
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Scientific data called into question the viability of the substance class
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PAION Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 31 May 2006 (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.
The main objective of this study is to investigate the tolerability of enecadin in patients with acute ischemic stroke. Furthermore, the pharmacokinetics of enecadin in both male and female patients with acute ischemic stroke will be assessed. Efficacy trends will be evaluated up to day 30 post stroke.
Detailed description
In the acute stage of ischemic stroke, an ischemic core characterized by a marked decrease in blood flow is present, leading to irreversible neuronal damage at an early stage. Around the boundary of the ischemic core, there is a region called ischemic penumbra in which functional recovery is possible after recirculation of blood flow within several hours after the onset, even though the blood flow is markedly decreased. Prevention of nerve cell death in the ischemic penumbra by neuroprotective therapy should greatly improve outcome and prognosis of acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EnecadinEnecadin |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with acute ischemic stroke (scoring 3-20 on the National Institutes of Health Stroke Scale [NIHSS]) with level of consciousness score: 0 or 1 (conscious patients) are eligible to be treated within 9 hours of onset of stroke symptoms.
- For female patients: post-menopausal or surgically sterile (post-menopausal: age ≥55 years and last menses ≥3 years ago).
Key exclusion criteria (5 listed)
- Participation in any investigational study in the previous 30 days.
- Patients unable to understand trial related information.
- History or evidence of severe heart diseases further specified in the protocol.
- History or evidence of additional diseases or results of baseline visit as specified in the protocol.
- Use of concomitant and prior medications as defined in the protocol.
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 |
|---|---|---|
| EnecadinDose escalating | Drug | 1 |
| PlaceboPlacebo comparator | Drug | 2 |
Primary outcome
Safety parameters, Pharmacokinetics & trends of efficacy
Time frame: One month
Results and safety
The study was stopped early (reason given: Scientific data called into question the viability of the substance class). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Peter A Ringleb, Dr. principal investigator
Heidelberg University
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enecadin in people with Stroke, run by PAION Deutschland GmbH at 26 sites in 3 countries.
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 5 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 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Belgium, Austria. 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 was stopped early (reason given: Scientific data called into question the viability of the substance class). 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?
Safety parameters, Pharmacokinetics & trends of efficacy (time frame: One month). 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 22 May 2008; AzTrials last refreshed its copy on 8 Nov 2026.