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Ramelteon and doxepin

Phase 3

Sleep Initiation and Maintenance Disorders | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Feb 28, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials4
Total Enrollment2,322
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00756002Safety and Efficacy Study of Ramelteon in Subjects With Chronic InsomniaPHASE3 COMPLETED 259 — — Aug 1, 2007Mar 1, 2008Jun 2, 2010 - —
NCT00671086Efficacy of Ramelteon in Subjects With Chronic InsomniaPHASE3 COMPLETED 1,213 — — Feb 1, 2003Sep 1, 2004Feb 28, 2012122 United States
NCT00755495Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic InsomniaPHASE2 COMPLETED 472 — — Jul 1, 2006Mar 1, 2007Feb 28, 2012 - —
NCT00755508Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With InsomniaPHASE2 COMPLETED 378 — — Nov 1, 2005Sep 1, 2006Feb 28, 2012 - —
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Study Endpoints
Primary Endpoints
Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2).
Nights 1-2

Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.

Adverse Events.
Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit.
Change from Baseline in Vital Signs.
Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit
Change from Baseline in Hematology Laboratory Tests.
Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Change from Baseline in Chemistry Laboratory Tests.
Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Change from Baseline in Urinalysis Laboratory Tests.
Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Electrocardiograms.
Month 6 and 12 or Final Visit.
Menstrual Diary Results.
Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Physical Examinations.
Months 2, 4, 8, 10, and 12 or Final Visit.
Mean wake time after persistent sleep onset during the double-blind Treatment Period, as measured by polysomnography
Weeks 1, 3, and 5 or Final Visit
Mean objective wake time after persistent sleep onset in sleep lab.
Nights: 1 and 2.
Secondary Endpoints
Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16).
Nights 15-16
Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30).
Nights 29-30
Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2).
Nights 1-2
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ramelteon 4 mg QDEXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -
Ramelteon 8 mg QDEXPERIMENTAL -
Ramelteon 16 mg QDEXPERIMENTAL -
Ramelteon 8 mg QD and Doxepin 3 mg QDEXPERIMENTAL -
Ramelteon 8 mg QD and Doxepin Placebo QDEXPERIMENTAL -
Ramelteon Placebo QD and Doxepin 3 mg QDACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Ramelteon 4 mg QD and Gabapentin 400 mg QDEXPERIMENTAL -
Ramelteon 8 mg QD and Gabapentin 800 mg QDEXPERIMENTAL -
Ramelteon 8 mg QD and Gabapentin Placebo QDEXPERIMENTAL -
Gabapentin 800 mg QDACTIVE_COMPARATOR -
Interventions
NameTypeDescription
RamelteonDRUGRamelteon 4 mg, tablets, orally, once daily for up to 5 weeks.
PlaceboDRUGRamelteon placebo-matching tablets, orally, once daily for up to 5 weeks.
Ramelteon and doxepinDRUGRamelteon 8 mg, tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.
DoxepinDRUGRamelteon placebo-matching tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.
Ramelteon and gabapentinDRUGRamelteon 4 mg, tablets, orally, once daily and gabapentin 400 mg, capsules, orally, once daily for up to one week.
GabapentinDRUGRamelteon placebo-matching tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study. * Has a body mass index between 18 and 34, inclusive. * Based on sleep history, the subject has had chronic insomnia for ...

Countries:United States
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