Neuroactive steroids, compositions, and uses thereof

a technology applied in the field of neuroactive steroids and compositions, to achieve the effect of reducing depression

Inactive Publication Date: 2017-12-07
SAGE THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0134]In some embodiments, the information related to therapeutic effect of a neuroactive steroid (e.g., allopregnanolone) is measured by reduction in HAM-D, EPDS, CGI, or GAD-7.
[0135]In an aspect, provided herein is a method of selecting a therapeutic compound (e.g., a neuroactive steroid) for treating depression or an anxiety disorder in a human subject treated with a neuroactive steroid (e.g., allopregnanolone) comprising the steps of: a) receiving information related to the therapeutic effect of a neuroactive steroid (e.g., allopregnanolone) in reducing the depression or anxiety disorder (e.g., symptoms of the depression or anxiety disorder) in a subject; and b) selecting the therapeutic compound (e.g., neuroactive steroid) if the information indicates that the depression or anxiety disorder (e.g., symptoms of the depression or anxiety disorder) is reduced in the subject as compared to the subject before having received the neuroactive steroid (e.g., allopregnanolone).

Problems solved by technology

In some embodiments, the method results in sedation.

Method used

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  • Neuroactive steroids, compositions, and uses thereof
  • Neuroactive steroids, compositions, and uses thereof
  • Neuroactive steroids, compositions, and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

Human Phase 1 Study of Allopregnanolone

[0358]A Double-Blind, Placebo-Controlled, Two-Period Crossover, Proof-of-Concept Study Evaluating the Safety, Tolerability, Pharmacokinetics, Efficacy of Allopregnanolone Injection in the Treatment of Patients with Essential Tremor

Study Design

[0359]A double-blind, proof-of-concept study designed to evaluate the safety, tolerability, PK, and efficacy of allopregnanolone injection in male or female patients with essential tremor in the upper limb. Each patient's involvement is up to 72 days, including up to a 28-day Screening Period, 12-hour Treatment Period 1 with 12-hour follow-up, 7-day (+ / −3 days) Washout Period, 12-hour Treatment Period 2 with 12-hour follow-up, a 7-day Follow-up Visit (Day 18 + / −1 day) plus an additional 23 days of SAE follow-up (with an End-of-Study visit via call on day 41). A representation of the Trial Design and activities is shown on FIG. 1.

[0360]Screening Period: As depicted in FIG. 1, the Screening Period begins beg...

example 2

Human Phase 1 Study of Allopregnanolone

[0418]An Open-Label Proof-of-Concept Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Allopregnanolone Injection in the Treatment of Adult Female Patients with Postpartum Depression

Study Design

[0419]A double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK, and efficacy of allopregnanolone injection in adult female patients diagnosed (by Structured Clinical Interview for DSM-V Axis I Disorders [SCID-I]) with severe PPD. Each patient's involvement is up to 37 days, including up to a 3-day screening period, 4-day (84-hour) active treatment period, and a 7-day AE follow-up period plus an additional 23 days of SAE follow-up (with a telephone call at day 11 and day 34).

[0420]Screening Period: The Screening Period begins with the signature of the informed consent form (ICF) in the Perinatal Psychiatry Inpatient Unit (PPIU) at the Screening Visit, which can occur on any one calendar day of t...

example 3

A Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Allopregnanolone Injection in the Treatment of Depression

Primary Objective:

[0484]To compare the effects of Allopregnanolone Injection and placebo infused intravenously for 48 hours on subject symptom response as measured by the Hamilton Rating Scale for Depression, 17-item (HAM-D-17)

Secondary Objectives:

[0485]To compare the effects of Allopregnanolone Injection and placebo on:[0486]Clinician evaluation as measured by the Clinical Global Impression-Improvement Scale (CGI-I)[0487]Sedation using the Stanford Sleepiness Scale (SSS)[0488]Safety and tolerability, assessed using adverse event reporting, vital sign measurement, laboratory data, ECG parameters, and suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS)[0489]Depressive symptom severity, reproductive mood disorders, and sleepiness as measured by the following clinician- and subject-rated outcome measures: Edin...

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Abstract

Described herein are methods of treating tremor, e.g., essential tremor; depression, e.g., postpostum depression; and anxiety disorder, the method comprising administering to a human subject suffering from tremor, e.g., essential tremor; depression, e.g., postpostum depression, an anxiety disorder with a neuroactive steroid or a composition comprising a neuroactive steroid (e.g., pregnanolone, allopregnanolone, alphadalone, ganaxolone, or alphaxolone).

Description

CLAIMS OF PRIORITY[0001]This application claims priority to U.S.S.N. 62 / 047,599, filed Sep. 8, 2014; U.S.S.N. 62 / 170,596, filed Jun. 3, 2015; and U.S.S.N. 62 / 213,015, filed Sep. 1, 2015, the entire contents of which are incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]Brain excitability is defined as the level of arousal of an animal, a continuum that ranges from coma to convulsions, and is regulated by various neurotransmitters. In general, neurotransmitters are responsible for regulating the conductance of ions across neuronal membranes. At rest, the neuronal membrane possesses a potential (or membrane voltage) of approximately −70 mV, the cell interior being negative with respect to the cell exterior. The potential (voltage) is the result of ion (K+, Na+, Cl+, organic anions) balance across the neuronal semipermeable membrane. Neurotransmitters are stored in presynaptic vesicles and are released under the influence of neuronal action potentials. When released int...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/573A61K9/00A61K47/40
CPCA61K31/573A61K9/0053A61K47/40A61K9/0019A61K31/57A61P25/14A61P25/24A61P25/28A61K31/56
Inventor KANES, STEPHEN JAYCOLQUHOUN, HELEN
Owner SAGE THERAPEUTICS
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