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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2006-002253-71-HU |
Date of registration:
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23/08/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A double-blind, multi-center, randomized withdrawal study evaluating the efficacy and safety of Amibegron (350 mg twice a day) versus placebo in the prevention of relapse of anxiety up to 1 year in patients with Generalized Anxiety Disorder improved after 12 weeks of open treatment with Amibegron (350 mg twice a day). - VEGA
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Scientific title:
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A double-blind, multi-center, randomized withdrawal study evaluating the efficacy and safety of Amibegron (350 mg twice a day) versus placebo in the prevention of relapse of anxiety up to 1 year in patients with Generalized Anxiety Disorder improved after 12 weeks of open treatment with Amibegron (350 mg twice a day). - VEGA |
Date of first enrolment:
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03/11/2006 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002253-71 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Randomized withdrawal
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Countries of recruitment
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Germany
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Hungary
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Italy
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Spain
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Key inclusion & exclusion criteria
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Inclusion criteria: For entry into the open phase: Patients suffering from generalized anxiety disorder, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and assessed with the Mini International Neuropsychiatric Interview (MINI) (7) plus GAD module with a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) = 20 at V1(D-4) and V2 (D-1).
For entry into the double-blind randomized phase: Improved patients with HAM-A score < 11 at V7 (W12). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Related to study methodology 1. Inpatients. 2. Patients < legal age of majority. 3. Patients unable to give voluntarily their written informed consent to participate in the whole study or to comply with the protocol and follow written and verbal instructions. 4. Patients with a diagnosis of Major Depressive Disorder as defined by DSM IV-TR within 6 months of screening. 5. Patients with a Montgomery and Asberg Depression Rating Scale (MADRS) (9) total score > 18 at screening (Visit 1, Day -4) or baseline (Visit 2, Day -1). 6. Patients at immediate risk for suicidal behavior based on an unstructured clinical interview; or who have, before first study drug intake [at either the screening (V1) or baseline (V2) visits]: • A score of > 5 on the suicidal thoughts item of the MADRS • Or, a current suicide risk score =10 from module C of the (MINI). 7. Patients with other current (within 6 months) anxiety disorder according to the MINI of: • Panic disorder, • Agoraphobia, • Social phobia, • Obsessive compulsive disorder (OCD), • Post-traumatic stress disorder (PTSD). 8. Patients with a lifetime history according to the MINI of: • Bipolar disorder, • Psychotic disorder, • Antisocial personality disorder. 9. Patients with a current history according to the MINI of: • Anorexia nervosa or bulimia nervosa in the past 6 months • Alcohol dependence or abuse or substance dependence or abuse in the past 12 months, except nicotine or caffeine dependence. 10. Patients who have used the following medications prior to screening: • Any continuous use of anxiolytic (e.g., benzodiazepines, buspirone) or hypnotic (e.g., zolpidem, zaleplon) within 2 weeks. Chronic means more than 2 days per week. • Any antipsychotic within 3 months, • Any antidepressant within 4 weeks, • Any mood-stabilizer (lithium, anticonvulsants) within 4 weeks. 11. Treatment with electroconvulsive therapy (ECT) or rapid Transcranial Magnetic Stimulation (r TMS) within 3 months prior to screening. 12. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening. 13. Patients with severe or unstable concomitant medical conditions (cardiovascular, neurological, gastrointestinal, hepatic, renal, endocrinologic, rhumatologic) according to the investigator's judgment that would impact the assessment of the study drug. 14. History of seizures other than a single childhood febrile seizure. 15. Patients with clinically significant abnormal laboratory value at screening, e.g. ALT or AST > 2 times upper limit of normal range (ULN), hemoglobin < 12g / 100ml for male and < 11g / 100ml for female, neutrophils < 1500/mm3, platelets < 100 000/mm3, creatinine = 150 µmol/l. 16. Patients with clinically significant ECG findings or positive results on the urine drug screen at screening. 17. Patients who have taken an investigational drug in the last 3 months prior to screening. 18. Any patient who has previously participated in a Amibegron protocol. 19. Females of childbearing potential with a positive ß-HCG pregnancy test at screening, or not using an effective method of birth control during the entire study period (i.e. birth control pill, intrauterine device, hormonal injection, sterilization or barrier method plus spermicide) and females pregnant or lactating.
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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General Anxiety Disorder
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Intervention(s)
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Product Name: NA Product Code: SR58611A Pharmaceutical Form: Film-coated tablet INN or Proposed INN: NA CAS Number: 121524-09-2 Current Sponsor code: SR58611A Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 350- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: To assess the efficacy of Amibegron on the secondary efficacy criteria. The secondary efficacy criteria will be the change from baseline (V7) of: • Clinical Global Impression (CGI) Severity of Illness score. • Hamilton Anxiety Rating Scale (HAM-A).
To assess the safety and tolerability of Amibegron in patients with generalized anxiety disorder. The safety criteria will be the following: • Vital signs (including weight) • Spontaneously-reported adverse events • Clinical laboratories • Physician Withdrawal Checklist (PWC) • Montgomery and Asberg depression rating scale (MADRS).
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Main Objective: To assess the efficacy of Amibegron 350 mg twice a day compared to placebo in the prevention of relapse of anxiety, in improved patients with generalized anxiety disorder (GAD), over a 24 to 52-week treatment period.
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Primary end point(s): The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by any one of the following criteria: • HAM-A total score = 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out, or • Any drop-out for lack of efficacy (according to investigator’s decision based on his/her knowledge of the patient), or • Prescription/use of alternative or additional treatments (pharmacological or nonpharmacological) for relief of psychiatric symptoms.
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Secondary ID(s)
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LTE5894
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2006-002253-71-ES
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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