Clinical Trials Logo
  1. Home
  2. Primary Insomnia
  3. NCT00209846
  4. Details
NCT00209846 Clinical Trial

A Study of Gaboxadol in Primary Insomnia

Primary Insomnia Clinical Trial

Official title:
A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00209846
Other study ID # 10402
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated March 29, 2007
Start date June 2004
Est. completion date November 2006

Study information
Verified date March 2007
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of gaboxadol in primary insomnia.

Description:

To obtain long-term safety data in elderly patients with gaboxadol.

Recruitment information / eligibility
Status Completed
Enrollment 320
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 66 Years and older
Eligibility Inclusion Criteria:

- patients with a diagnosis of primary insomnia

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gaboxadol

Locations
Country Name City State
Sweden Non-US study, principal location: Göteborg

Sponsors (1)
Lead Sponsor Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety
Primary Tolerability
See also
  Status Clinical Trial Phase
Terminated NCT03461666 - Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia N/A
Recruiting NCT02243501 - Better Nights, Better Days for Typically Developing Children N/A
Completed NCT01636791 - CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care Phase 3
Completed NCT00770510 - A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126) Phase 2/Phase 3
Completed NCT00520832 - A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys Phase 2
Recruiting NCT00415714 - Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia N/A
Terminated NCT00420810 - Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED) Phase 3
Completed NCT00178048 - Paroxetine in the Treatment of Chronic Primary Insomnia Phase 4
Completed NCT00816673 - Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs Phase 2
Completed NCT01960452 - A High Density EEG Comparison of Sleep Patterns in Insomnia N/A
Completed NCT01957111 - Metabolomics of Insomnia-Related Hyperarousal N/A
Completed NCT01181232 - A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients Phase 4
Completed NCT00784875 - An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia Phase 2
Completed NCT00551148 - A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia Phase 2
Completed NCT00397189 - Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients Phase 3
Completed NCT00352144 - 6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia Phase 3
Completed NCT02290405 - Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
Completed NCT03314441 - Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia N/A
Completed NCT00792298 - Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006) Phase 2
Completed NCT01021852 - Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011) Phase 2