NCT03702803: Alpra

Efficacy and Safety Study of a IMSS Developed Phytopharmaceutical for the Treatment of Anxiety.

Status unknown Phase 2 Last updated 14 July 2020

What this trial tests

Phase 2 trial testing Galphimia glauca standardized extract in Generalized Anxiety Disorder in 122 participants. Status unknown.

Timeline

16 March 2016

Primary endpoint
19 September 2020

19 October 2020

Quick facts

Lead sponsor	Coordinación de Investigación en Salud, Mexico
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	122
Start date	16 March 2016
Primary completion	19 September 2020
Estimated completion	19 October 2020
Sites	1 location across Mexico

Drugs / interventions tested

• Galphimia glauca standardized extract
• alprazolam 1mg

Conditions studied

• Generalized Anxiety Disorder — all drugs for Generalized Anxiety Disorder →

Sponsor

Coordinación de Investigación en Salud, Mexico — full company profile →

Who can join

18 and older, any sex, with Generalized Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigator's group at the Mexican Institute of Social Security has worked for more than 20 years in the scientific research of the plant species Galphimia glauca Cav., which is used in Mexican Traditional Medicine for the treatment of mental disorders. With the obtained results it was possible the development of a phytopharmaceutical elaborated with the extract of this plant, which was standardized in its content of Galphimine-B (G-B). This new compound is a nor, seco-triterpene, which possesses selective effects on the central nervous system. Through electrophysiological neuronal unitary records it was identified that G-B acts on the ventral tegmental area (VTA), and exerts its effect on (N-methyl-D-aspartate) NMDA receptors in dopaminergic neurons. The new phytopharmaceutical, elaborated from a standardized extract (in its G-B content) of G. glauca, was subjected to a double blind and randomized clinical study that compared its efficacy and therapeutic tolerability with a similar drug formulated with lorazepam in patients with diagnosis of generalized anxiety disorder (GAD). In a total of 152 patients, it was evidenced that the phytomedicine administered orally (for 4 weeks) was able to significantly reduce anxiety, in a similar way as lorazepam did, but with better tolerability. Several patients who were treated with lorazepam had to leave the study because they had daytime sleepiness.

In clinical practice, different benzodiazepines have specific indications. In the case of anxiety disorders, the drug of first choice is Alprazolam, this, because it manifests a more powerful anxiolytic effect with a lower degree of sedation and daytime sleepiness.

Objective: The present project aims to compare the efficacy and therapeutic safety of an elaborated phytopharmaceutical with the standardized extract of Galphimia glauca with Alprazolam .

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options.
   Garakani A, Murrough JW, Freire RC, Thom RP, et al · · 2020 · cited 213× · PMID 33424664 · DOI 10.3389/fpsyt.2020.595584
2. Galphimine-B Standardized Extract versus Alprazolam in Patients with Generalized Anxiety Disorder: A Ten-Week, Double-Blind, Randomized Clinical Trial.
   Romero-Cerecero O, Islas-Garduño AL, Zamilpa A, Herrera-Arellano A, et al · · 2019 · cited 5× · PMID 30834253 · DOI 10.1155/2019/1037036