Clinical Trial Result Information

Protocol number
ML17260

Title of Study
Safety evaluation on different discontinuation regimens in patients with generalized anxiety disorder associated with clinical disease

Sponsor
F.Hoffmann-La Roche Ltd

Company division
Pharmaceutical

Product name
Lexotan

Generic name
bromazepam

Therapeutic area
Anxiety Disorders

Clinical study summary
This trial was prematurely terminated, due to slow recruitment. Clinical trial results, other than key safety statements, have not been posted, due to insufficient data.

Study center(s)
4 centers in Brazil

Phase of development
IV

Objectives
Primary: To observe signs and symptoms, and change in the variety of anxiety symptoms and vital signs, arising from the discontinuation of three medication withdrawal regimens. Secondary: to evaluate the efficacy of lexotan in anxiety symptoms associated with concomitant clinical disease

Methodology
Patients were randomized to one of 3 alternative medication withdrawal regimens

Number of patients (planned/analyzed)
36 patients randomized

Diagnosis and main criteria for inclusion
Male or female patients, aged 18-65 years of age, with a diagnosis of generalized anxiety disorder made within the past 6 months

Test product, dose and mode of administration or test procedure
Lexotan (bromazepam) 3mg tablets

Duration of treatment
8 weeks (planned)

Criteria for evaluation (efficacy, safety)
Efficacy: HAM-A scale, sleep miniquestionnaire. Safety: Evaluation Scale for the Symptoms of Withdrawal of CNS Depressants, proportion of patients exhibiting signs and symptoms or anxiety rebound, adverse events, vital signs, weight.

Statistical methods
Because of the premature termination of the study, the data were not evaluated.

Summary (efficacy, safety, other results)
There were no deaths during this study, and no serious adverse events considered to be related to treatment.

Conclusions
No conclusions can be drawn from this study, due to its early termination

Date of report
3/15/2006