MedPath

Gaboxadol

Generic Name
Gaboxadol
Drug Type
Small Molecule
Chemical Formula
C6H8N2O2
CAS Number
64603-91-4
Unique Ingredient Identifier
K1M5RVL18S
Background

Gaboxadol also known as 4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol (THIP) is an experimental sleep aid drug developed by Lundbeck and Merck, who reported increased deep sleep without the reinforcing effects of benzodiazepines. Development of Gaboxadol was stopped in March 2007 after concerns regarding safety and efficacy. It acts on the GABA system, but in a seemingly different way from benzodiazepines and other sedatives.

Indication

Investigated for use/treatment in sleep disorders and insomnia.

Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS)

Phase 2
Recruiting
Conditions
Fragile X Syndrome
Interventions
Drug: Placebo
First Posted Date
2024-03-28
Last Posted Date
2024-03-28
Lead Sponsor
Craig Erickson
Target Recruit Count
10
Registration Number
NCT06334419
Locations
🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40

First Posted Date
2021-03-30
Last Posted Date
2022-12-08
Lead Sponsor
Healx Limited
Registration Number
NCT04823052
Locations
🇺🇸

University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States

🇺🇸

Emory University School of Medicine, Atlanta, Georgia, United States

🇺🇸

Rush University Medical Center & Children's Hospital, Chicago, Illinois, United States

and more 7 locations

A Study of OV101 in Individuals With Angelman Syndrome (AS)

Phase 3
Completed
Conditions
Primary Disease or Condition Being Studied: Angelman Syndrome (AS)
Interventions
Drug: Placebo
First Posted Date
2019-09-27
Last Posted Date
2024-01-08
Lead Sponsor
Ovid Therapeutics Inc.
Target Recruit Count
104
Registration Number
NCT04106557
Locations
🇳🇱

Ovid Therapeutics Investigative Site, Rotterdam, Netherlands

An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome

Phase 3
Terminated
Conditions
Angelman Syndrome
Interventions
First Posted Date
2019-03-20
Last Posted Date
2022-02-04
Lead Sponsor
Ovid Therapeutics Inc.
Target Recruit Count
125
Registration Number
NCT03882918
Locations
🇮🇱

Ovid Therapeutics Investigative Site, Ramat Gan, Israel

Single Dose Pharmacokinetic (PK) Study

Phase 1
Completed
Conditions
Angelman Syndrome
Fragile X Syndrome
Interventions
First Posted Date
2017-04-12
Last Posted Date
2017-11-30
Lead Sponsor
Ovid Therapeutics Inc.
Target Recruit Count
12
Registration Number
NCT03109756
Locations
🇺🇸

Ovid Therapeutics Investigative Site, Nashville, Tennessee, United States

Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder

First Posted Date
2008-12-11
Last Posted Date
2012-12-17
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
490
Registration Number
NCT00807248
Locations
🇷🇺

RU011, Yaroslavl, Russian Federation

🇷🇺

RU014, Volgograd, Russian Federation

🇷🇺

RU015, Moscow, Russian Federation

and more 19 locations

MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)

Phase 2
Completed
Conditions
Primary Insomnia
First Posted Date
2005-12-16
Last Posted Date
2015-01-14
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
520
Registration Number
NCT00266344

A Study of Gaboxadol in Primary Insomnia

Phase 3
Completed
Conditions
Primary Insomnia
First Posted Date
2005-09-21
Last Posted Date
2007-03-30
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
505
Registration Number
NCT00209924
Locations
🇸🇪

Non-US study, principal location:, Göteborg, Sweden

A Study of Gaboxadol in Primary Insomnia

Phase 3
Completed
Conditions
Primary Insomnia
First Posted Date
2005-09-21
Last Posted Date
2007-03-30
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
600
Registration Number
NCT00209963

A Study of Gaboxadol in Primary Insomnia

Phase 3
Completed
Conditions
Primary Insomnia
First Posted Date
2005-09-21
Last Posted Date
2007-03-30
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
320
Registration Number
NCT00209846
Locations
🇸🇪

Non-US study, principal location:, Göteborg, Sweden

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