Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.

NCT00383643 | Completed Phase 2 Results

• 1 other identifier: 95900
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each of these two medications with placebos.

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (5)

• Assessment of Clinical Global Impression-change.

  Clinician assessment of Clinical Global Impression-Change score at week 12 of treatment intervention. The Clinical Global Impression - Change scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the current time point. It is rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. One one clinician provided the ratings in this trial.

  Baseline to week 12

• Assessment of Insomnia Severity Index

  Current self-report on Insomnia Severity Index at week 12 of treatment intervention. This is a seven-item questionnaire where the sum of the answers indicate the severity of insomnia. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)

  12 weeks

• Assessment of Pittsburgh Sleep Quality Index (PSQI)

  Current self-report on Pittsburgh Sleep Quality Index (PSQI) at week 12 of intervention. Consisting of 19 items, the PSQI measures several different aspects of sleep which can be combined into one global score. Each item measure is scored on a scale of 0 to 3 where 3 is the extreme negative. The composite PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Based on this questionnaire, a composite score of 5 or greater is indicative of poor sleep quality.

  One month

• Assessment of Fatigue

  Current self-report on Profile of Mood State -- Fatigue (POMS-F) at week 12 of intervention. This subscale of the POMS consists of 7 items each scored on a scale of 0 (not at all) to 4 (extremely) which are summed to provide a composite score of fatigue. The range is 0 to 28 for this subscale. Higher scores indicate more fatigue.

  One month

• Assessment of Sleepiness

  Current self-report on Epworth Sleepiness Scale (ESS) at week 12 of intervention. This measure consists of 8 scenarios in which the participant is asked to assess how likely s/he is to fall asleep. Scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. Responses are summed for a total score ranging from 0 to 24. The higher the score, the greater the self-reported sleepiness. Scores of 9 and below are considered in the normal range.

  One month

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Eligible subjects randomized to this arm received placebo as gelatin capsule and a liquid capsule to fully maintain the blind.

Drug: Matching Placebos

Zolpidem tartrate

ACTIVE COMPARATOR

Eligible subjects randomized to this arm received zolpidem as gelatin capsule and a placebo liquid capsule to fully maintain the blind.

Drug: zolpidem tartrate; Drug: Matching Placebos

Sodium oxybate

ACTIVE COMPARATOR

Eligible subjects randomized to this arm received placebo as gelatin capsule and a sodium oxybate capsule to fully maintain the blind.

Drug: sodium oxybate; Drug: Matching Placebos

Interventions

zolpidem tartrate DRUG

Also known as: Ambien, Zolpidem

Zolpidem tartrate

sodium oxybate DRUG

Also known as: Xyrem

Sodium oxybate

Matching Placebos DRUG

Also known as: Placebo, Sugar pill

Placebo; Sodium oxybate; Zolpidem tartrate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent is obtained.
• The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age (inclusive).
• Patient reports insomnia for at least six months, and insomnia causes the patient distress.
• The Investigator determines that the patient meets diagnostic criteria for Chronic Insomnia according to International Classification of Sleep Disorders (ICSD) criteria.
• Sleep diary based screening shows sleep onset latency \>30 minutes, and /or wake after sleep onset \>30 minutes per night at least 3 nights per week, with combined wake-time-in-bed \_\> 45 minutes.
• The patient is in good health as determined by a medical and psychiatric history, and physical examination.
• Women must be surgically sterile, 2 years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control, and agree to continued use of this method for the duration of the study.
• The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.

You may not qualify if:

• Has any clinically significant, uncontrolled medical or psychiatric conditions. (treated or untreated)
• Has a probable diagnosis of a current sleep disorder other than Chronic Insomnia.
• Used any prescription drugs disallowed by the protocol or clinically significant use of over-the counter(OTC) drugs within 14 days before the screening visit.
• Has a history of alcohol, narcotic, or any other abuse as defined by the DSM-V.
• Has a clinically significant deviation from normal in the physical examination.
• Is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
• Has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery and succinic semialdehyde dehydrogenase deficiency)
• Has a known clinically significant drug sensitivity to sodium oxybate or sedative hypnotics.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem; Sodium Oxybate; Sugars

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Limitations and Caveats

Insufficient power for most parameters was a planned limitation of the study. Replication with a larger sample is needed.

Results Point of Contact

• Title: Dr. Jed Black
• Organization: Stanford University School of Medicine, Dept of Psychiatry

jedblack@stanford.edu

650 736 4559

Study Officials

• Jed E Black, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-04

Locations

US (1)