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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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14 August 2012 |
Main ID: |
EUCTR2007-004768-32-AT |
Date of registration:
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14/03/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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LONG TERM SAFETY AND EFFICACY STUDY OF PREGABALIN IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER - N/A
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Scientific title:
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LONG TERM SAFETY AND EFFICACY STUDY OF PREGABALIN IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER - N/A |
Date of first enrolment:
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11/03/2008 |
Target sample size:
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794 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004768-32 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Austria
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Czech Republic
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Finland
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Greece
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Lithuania
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Slovenia
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Spain
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Men and women age 18 to 65 years. Women of childbearing potential must use a reliable method of birth control during the study period. 2. Primary DSM IV diagnosis of GAD (DSM IV, 300.02)8 as established by a psychiatrist or licensed clinical psychologist and confirmed by the Mini-International Neuropsychiatric Interview (MINI) structured interview.9 3. HAM A total score =14 and item #1 on the HAM D with a depressed mood score =2 at both the Screening (Visit 1) and Baseline (Visit 2) visits to ensure predominance of anxiety symptoms over depression. 4. Subjects who require pharmacologic treatment for GAD. 5. Able to understand and cooperate with study procedures and to give informed consent. 6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Current or past diagnosis of any other DSM IV Axis I disorders (including current premenstrual dysphoric disorder) with the following exceptions: • Current or past depression not otherwise specified, specific phobia, or somatization disorder; and • Past history of major depressive disorder, social phobia, panic disorder, or of an eating disorder. 2. DSM IV substance (except for nicotine and caffeine) abuse or dependence within the past 6 months. 3. Presence of comorbid borderline and antisocial personality disorders, based on DSM IV criteria per the investigator’s clinical judgment. 4. Suicide risk by history within past 2 years, self-report, or clinically judged to be at serious suicidal or homicidal risk. 5. Stopping or initiating psychotherapy for GAD in Period 2 or 3. Subjects with psychotherapy of stable intensity for at least 6 weeks or more are allowed to enter the study. 6. Daily use of benzodiazepines for treating GAD (=5 days/week) during the 3 months prior to screening. Occasional use of benzodiazepine for insomnia is allowed but not within 2 weeks of baseline. 7. Current use of psychotropic medications that can not be discontinued 2 weeks prior to baseline (5 weeks for fluoxetine). 8. A history of failed treatment with lorazepam as determined by the clinical judgment of the investigator and taking into account adequacy of dose and the duration of treatment. 9. Known sensitivity to lorazepam or other benzodiazepines. 10. Prior exposure to pregabalin. 11. A positive urine drug screen at screening for any of the following substances or classes of compounds: amphetamines, barbiturates, benzodiazepines, narcotics, sedatives and hypnotics, cocaine, phencyclidine, cannabinoids, or other illegal or illicit drugs. 12. A positive breathalyzer test at screening. 13. Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder, including, but not limited to: • Any seizure disorder. • Uncorrected hypothyroidism or hyperthyroidism. Subjects must be on stable thyroid replacement therapy for hypothyroidism for at least 6 weeks prior to screening. • History of life-threatening neoplasm treated within the last 5 years, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin. • History of migraine headaches occurring more than once a month. • Narrow angle glaucoma. 14. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >3 tmes the upper limit of normal. 15. Platelet count <100,000/mm3. 16. Serum sodium >150 or <130 mEq/L. 17. Creatinine clearance (CLcr) <45 mL/min. 18. Clinically significant electrocardiogram (ECG) abnormalities. 19. Pregnancy or lactation. 20. Participation in an experimental drug study within the last 30 days. 21. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or sponsor, would make the subject inappropriate for entry into this study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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GENERALIZED ANXIETY DISORDER (GAD) MedDRA version: 9.1
Level: LLT
Classification code 10018105
Term: Generalized anxiety disorder
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Intervention(s)
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Trade Name: Lyrica Pharmaceutical Form: Capsule* INN or Proposed INN: Pregabalin CAS Number: 148553-50-8 Current Sponsor code: Lyrica Other descriptive name: (s)-3-(aminomethyl)-5-methylhexanoic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
Trade Name: Lyrica Pharmaceutical Form: Capsule* INN or Proposed INN: Pregabalin CAS Number: 148553-50-8 Current Sponsor code: Lyrica Other descriptive name: (s)-(aminomethyl)-5-methylhexanoic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
Trade Name: Lyrica Pharmaceutical Form: Capsule* INN or Proposed INN: Pregabalin CAS Number: 148553-50-8 Current Sponsor code: Lyrica Other descriptive name: (s)-(aminomethyl)-5-methylhexanoic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 225- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
Trade Name: Lyrica Pharmaceutical Form: Capsule* INN or Proposed INN: Pregabalin CAS Number: 148553-50-8 Current Sponsor code: Lyrica Other descriptive name: (s)-(aminomethyl)-5-methylhexanoic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
Trade Name: Lorazepam Product Name: Lorazepam Pharmaceutical Form: Capsule* INN or Proposed INN: Lorazepam CAS Number: 846-49-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Efficacy Endpoints • Hamilton Anxiety Rating Scale (HAM A total): A 14 question rating scale that assesses anxiety symptoms which will be measured at baseline (prior to treatment) and at 3 and 6 months post treatment. • Clinical Global Impressions Severity and Improvement (CGI S and CGI I) will be collected at the same time points as the HAM A.
Safety Endpoints • Adverse events from spontaneous reports will be monitored throughout the trial. Adverse events will be summarized by treatment group following 3 and 6 months of GAD treatment. • Drug Discontinuation and Rebound Anxiety: • Physicians Withdrawal Checklist (PWC): A questionnaire to collect information to determine whether subjects experience discontinuation symptoms after cessation of study medication. • Rebound Anxiety: The HAM A will be used to characterize rebound anxiety, defined as a rapid return of the subject’s original symptoms following drug discontinuation, that are worse compared to baseline. • Discontinuation Emergent Signs and Symptoms (DESS) associated with drug discontinuation will be characterized at 3 and 6 months: DESS will be determined from spontaneously reported treatment emergent adverse events that either newly developed during the taper, or existed prior to but worsened during the tapering period.
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Main Objective: To characterize the safety and efficacy of pregabalin in subjects with GAD at low and high doses relative to placebo and lorazepam following 3 and 6 months of treatment.
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Secondary Objective: N/A
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Secondary ID(s)
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A0081147
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2007-004768-32-ES
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N/A
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Source(s) of Monetary Support
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Results
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Results available:
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