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Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia

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ClinicalTrials.gov Identifier: NCT00606593
Recruitment Status : Completed
First Posted : February 4, 2008
Results First Posted : March 11, 2013
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Midnight Pharma, LLC

Tracking Information
First Submitted Date  ICMJE January 4, 2008
First Posted Date  ICMJE February 4, 2008
Results First Submitted Date  ICMJE December 21, 2012
Results First Posted Date  ICMJE March 11, 2013
Last Update Posted Date March 14, 2016
Study Start Date  ICMJE December 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
Mean Wake Time After Sleep Onset (WASO) [ Time Frame: 2 treatment nights ]
WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
Mean wake time after sleep onset. [ Time Frame: 2 treatment nights ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
Mean Total Sleep Time (TST) [ Time Frame: 2 treatment nights ]
TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)). Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
Mean total sleep time. [ Time Frame: 2 treatment nights. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
Official Title  ICMJE Multicenter, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Dose-finding Study to Evaluate the Efficacy and Safety of Oral Administration of ACT-078573 in Elderly Subjects With Chronic Primary Insomnia
Brief Summary A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Primary Insomnia
Intervention  ICMJE
  • Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo
    5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
  • Drug: ACT-078573 and matching placebo
    ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Study Arms  ICMJE
  • Experimental: ABECD
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo
  • Experimental: BCADE
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 and matching placebo
  • Experimental: CDBEA
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 and matching placebo
  • Experimental: DECAB
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 and matching placebo
  • Experimental: EADBC
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 and matching placebo
  • Experimental: DCEBA
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 and matching placebo
  • Experimental: EDACB
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 and matching placebo
  • Experimental: AEBDC
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 and matching placebo
  • Experimental: BACED
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 and matching placebo
  • Experimental: CBDAE
    5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
    Intervention: Drug: ACT-078573 and matching placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2012)
112
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2008)
80
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Elderly subjects (> 64 years) with a diagnosis of primary insomnia.

Exclusion Criteria:

  • History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I disorder other than primary insomnia.
  • Sleep apnea, or restless legs syndrome.
  • Daytime napping of more than 1 hour per day.
  • Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
  • Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606593
Other Study ID Numbers  ICMJE AC-057A201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Midnight Pharma, LLC
Study Sponsor  ICMJE Midnight Pharma, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James K. Walsh, PhD Sleep Medicine and Research Center
PRS Account Midnight Pharma, LLC
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP