Panic DisorderPhase 2NCT00322803
ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
A Phase 2 study testing ELB139 in people with Panic Disorder, run by elbion AG at 3 sites in 2 countries.
Trial summary
This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- ELB139
- How many people
- 24 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2006to Oct 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of concurrent panic disorder
- At least 2 panic attacks within the 4 weeks before the screening visit
- Naïve to the CO2 challenge test
- Age 18-65 years (inclusive)
- Ability to comply with all procedures mandated by the study protocol
- Negative pregnancy test and adequate contraceptive measures
Who cannot join
- History of poly-pharmacotherapy for panic disorder or treatment resistance
- Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia
- History of abuse of benzodiazepines or tolerance to effects of benzodiazepine
- Any concomitant psychotropic medication
- Evidence of impaired hepatic, renal or cardiac functions
- Participation in any drug trial in the preceding 6 months
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Charité - University Clinics Berlin
Berlin, 10117
Emovis, The institute of emotional health
Berlin, 10629
Netherlands1 site
Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
Maastricht, 6200 MD
About this study
Official title: International, Multicenter, Randomized, Double-Blind, Placebo Controlled, Two-Period, Cross-Over Study to Demonstrate Safety, Tolerability and Anxiolytic Effects of 600 mg ELB139 Given Orally t.i.d. to Patients With Concurrent Panic Disorder, Challenged by Inhalation of 35% CO2 After a Single Dose and One Week of Treatment
This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.
- Conditions
- Panic Disorder
- Being tested
- ELB139
- Keywords
- panic disorder, proof of concept
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELB139Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)
difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta)
Secondary outcomes (2)
Total Symptom Score assessed immediately after CO2 challenge (TSS-post)
Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startMay 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- elbion AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Griez, Prof Dr, Principal investigator, Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322803
- Sponsor's protocol ID
- ELB139202-05
- Other IDs
- EudraCT Number:2005-005708-17
- Status last verified
- Sep 2006
- First submitted
- 5 May 2006
- Last updated
- 29 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Randomized, Double-Blind, Placebo Controlled, Two-Period, Cross-Over Study to Demonstrate Safety, Tolerability and Anxiolytic Effects of 600 mg ELB139 Given Orally t.i.d. to Patients With Concurrent Panic Disorder, Challenged by Inhalation of 35% CO2 After a Single Dose and One Week of Treatment
- ClinicalTrials.gov ID
- NCT00322803
- Acronym / sponsor ID
- ELB139202-05
- Conditions
- Panic Disorder
- Keywords
- panic disorder, proof of concept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants
- Lead sponsor
- elbion AGIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Oct 2006
- First posted
- 8 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.
This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of concurrent panic disorder
- At least 2 panic attacks within the 4 weeks before the screening visit
- Naïve to the CO2 challenge test
- Age 18-65 years (inclusive)
- Ability to comply with all procedures mandated by the study protocol
Key exclusion criteria (6 listed)
- History of poly-pharmacotherapy for panic disorder or treatment resistance
- Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia
- History of abuse of benzodiazepines or tolerance to effects of benzodiazepine
- Any concomitant psychotropic medication
- Evidence of impaired hepatic, renal or cardiac functions
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 |
|---|---|---|
| ELB139 | Drug | – |
Primary outcome
degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)
difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta)
2 secondary outcomes
Total Symptom Score assessed immediately after CO2 challenge (TSS-post)
Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)
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 29 Sep 2006.
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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.
Eric Griez, Prof Dr principal investigator
Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ELB139 in people with Panic Disorder, run by elbion AG at 3 sites in 2 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 6 inclusion and 6 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 29 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Netherlands. 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 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. 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?
degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post). The study lists 2 primary outcomes in all. 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 29 Sep 2006.