Clinical Trials

Date: 2017-04-05

Type of information: Results

phase: 2

Announcement: results

Company: Allergan (Ireland)

Product: Botox® (onabotulinumtoxinA)

Action mechanism: protein.

Disease: major depressive disorder (MDD)

Therapeutic area: CNS diseases - Mental diseases

Country:

Trial details:

The study was a proof of concept Phase II, multi-center, randomized, double-blind, placebo-controlled, 2-dose cohort parallel group, single treatment study in adults females with moderate to severe major depressive disorder. 258 patients (with a minimum total score of 18 on the Hamilton Rating Scale for Depression and a score of 4 on the Clinical Global Impressions Scale) were randomized (1:1:2) into three groups receiving either Botox® 30 U, Botox® 50 U or placebo. As the number of injections differed between the 30 U and the 50 U group, each study site was randomly assigned to only one of the doses and matching placebo. The study took place over 26 weeks with a 2 week screening period and up to 24 weeks post DB treatment. The primary endpoint of the study was change from baseline to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score for Botox® 30 U vs. placebo and Botox® 50 U vs. placebo; and combined Botox® 30 U and 50 U vs. combined placebo groups.

Latest news:

• On April 5, 2017, Allergan announced data from a Phase II study with major depressive disorder. The study evaluated the efficacy, safety and tolerability of a single administration of 2 different doses of Botox® (30 units or 50 units) relative to placebo in adult females with major depressive disorder over duration of up to 24 weeks. The Botox® 30 U dose demonstrated numerically superior efficacy in MADRS total score compared to placebo. The treatment (LS mean) difference for 30 U was -4.2 at 3 weeks (p- value 0.005); -3.7 at week 6 (p-value 0.053) and -3.6 at week 9 (p-value 0.049). The primary end point was at week 6. The 50 U did not demonstrate superior efficacy over placebo (LS mean difference was 1.3). Both secondary efficacy variables (CGI-S and HAMD-17) showed numerically superior efficacy over placebo and trended in the same direction as the primary efficacy variable for 30 U, but not for 50 U. Both 30 U and 50 U were well tolerated. Allergan now plans to develop a phase 3 program in CNS diseases, including major depressive disorder.