## Protocol Section
### Identification Module
**NCT ID:** NCT00452179

**Brief Title:** Safety and Efficacy Study of APD125 in Patient With Insomnia

**Official Title:** A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Effects of APD125 in Patients With Chronic Primary Insomnia

#### Organization Study ID Info
**ID:** APD125-004
#### Organization
**Class:** INDUSTRY
**Full Name:** Arena Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2007-06

**Type:** ACTUAL

#### Last Update Post Date
**Date:** 2007-09-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2007-09-06

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2007-02

**Status Verified Date:** 2007-09

#### Study First Post Date
**Date:** 2007-03-27
**Type:** ESTIMATED
**Study First Submit Date:** 2007-03-23
**Study First Submit QC Date:** 2007-03-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Arena Pharmaceuticals

### Description Module

**Brief Summary:** The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.

### Conditions Module

**Conditions:**

- Insomnia

**Keywords:**

- Sleep maintenance

- Insomnia

- Sleep Consolidation

- Sleep

- Insomnia, primarily sleep maintenance

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 173

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** APD125

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Conventional PSG parameters

#### Secondary Outcomes

**Measure:** Patient reported subjective sleep parameters

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG
* PSQI \>/= to 5
* Qualifying screening PSG parameters
* Generally good health

Exclusion Criteria:

* History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
* Any clinically significant medical condition, laboratory finding, or ECG finding
* Pregnant and/or lactating females
* History of substance abuse within 2 years or positive urine drug screen
* Positive Hepatitis B/C results or HIV markers
* Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) \> 10 as determined by screening PSG
* History of treatment with an investigational drug within the last month
* Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (\> 3 time zones) during the study

**Maximum Age:** 64 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Diego

**Country:** United States

**State:** California

**Zip:** 92121

#### Overall Officials

**Official 1:**

**Affiliation:** Arena Pharmaceuticals

**Name:** Warren A Prosser

**Role:** STUDY_DIRECTOR

### References Module

#### See Also Links

**Label:** Arena Pharmaceuticals Home Page

**URL:** http://www.arenapharm.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10356

- Name: Sleep Initiation and Maintenance Disorders

- Relevance: HIGH

- As Found: Insomnia

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007319

- Term: Sleep Initiation and Maintenance Disorders

### Misc Info Module

- Version Holder: 2024-05-24
