LONG TERM SAFETY AND EFFICACY STUDY OF PREGABALIN IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER - N/A

• Register: EUCTR
• Last refreshed on: 14 August 2012
• Main ID: EUCTR2007-004768-32-FI
• Date of registration: 26/02/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
• Public title: LONG TERM SAFETY AND EFFICACY STUDY OF PREGABALIN IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER - N/A
• Scientific title: LONG TERM SAFETY AND EFFICACY STUDY OF PREGABALIN IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER - N/A
• Date of first enrolment: 03/04/2008
• Target sample size: 794
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004768-32
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Austria, Czech Republic, Finland, Greece, Lithuania, Slovenia, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Men and women age 18 to 65 years. Women of childbearing potential must use an
acceptable method of birth control during the study period.
2. Primary DSM IV diagnosis of GAD (DSM IV, 300.02) as established by a psychiatrist or licensed clinical psychologist and confirmed by the Mini-International Neuropsychiatric Interview (MINI) structured interview.
3. HAM-A total score =18 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. Current or past DSM-IV substance (except for nicotine and caffeine) abuse or dependence.
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 during the study. 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 4 weeks prior to screening. Occasional use of benzodiazepine for insomnia (eg, 2 or 3 times per month) 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 benzodiazopine 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 current seizure disorder.
• Uncorrected hypothyroidism or hyperthyroidism. Subjects must be on stable thyroid replacement therapy for hypothyroidism for at least 6 weeks prior to screening and thyroid hormones (FT4 and TSH) must be within normal range at 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 for the past year
other than those associated with menstruation.
• 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) <60 mL/min (estimated by Cockroft-Gault method).
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

Health Condition(s) or Problem(s) studied

GENERALIZED ANXIETY DISORDER (GAD)
MedDRA version: 9.1 Level: LLT Classification code 10018105 Term: Generalized anxiety disorder

Intervention(s)

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

Primary Outcome(s)

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.

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.

Secondary Objective: N/A

Secondary ID(s)

2007-004768-32-ES

A0081147

N/A