Back to resultsEfficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
Primary Purpose
Non-24-Hour Sleep-Wake Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tasimelteon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-24-Hour Sleep-Wake Disorder focused on measuring Blindness, Eye Diseases, Nap Disorders, Circadian Rhythm Disorders, Sleep disorders, Circadian Rhythm Sleep Disorders, Dyssomnias, Nervous System Diseases
Eligibility Criteria
Inclusion Criteria:
- Ability and acceptance to provide informed consent;
- No perception of light by the subject's own report;
Diagnosis of N24HSWD as determined by:
- History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire and
- Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.
- Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
- Fluent in English;
Exclusion Criteria:
- Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
- Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
- History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;
- History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
- Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study;
- Unable to perform calls to the study IVR system to report questionnaire results;
- Exposure to any investigational drug, including placebo, within 30 days or 5 half lives (whichever was longer) of screening;
- Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle
- Use of melatonin or melatonin agonist
Sites / Locations
- Pulmonary Associates, PA
- SDS Clinical Trials Inc.
- VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area)
- St. Johns Sleep Disorder Center - St. Johns Medical Plaza
- Radiant Research - Denver
- PAB Clinical Research Inc.
- Kendall South Medical Center, Inc.
- Ocean Sleep Disorders Center - Ormond Beach
- Sleep Disorders Center Of Georgia
- Suburban Lung Associates SC (Chicago Metropolitan Area)
- The Center for Sleep and Wake Disorders (Washington, D.C. Metropolitan Area)
- Brigham and Women's Hospital
- Michigan Head-Pain Neurological Institute
- St. Luke's Sleep Medicine and Research Center (St. Louis Metropolitan Area)
- New York Eye and Ear Infirmary
- Tri-State Sleep Disorders Center
- Ohio Sleep Medicine Institute (Columbus Metropolitan Area)
- Lynn Health Science Institute
- Columbia Research Group Inc.
- Center For Sleep Medicine at Chestnut Hill Hospital
- Consolidated Clinical trials
- SleepMed, Inc. - Columbia
- Todd J. Swick, M.D., P.A.
- Advanced Sleep Research GmbH
- Bergmannsheil University Hospital - Medical Clinic III
- Klinische-Forschung Hannover Mitte
- Universitaetsklinikum Glesen and Marburg gmbH/Schlaflabor - Sleep Lab University Marburg
- Bonomed Studiezentrum
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
tasimelteon
placebo
Arm Description
20 mg tasimelteon capsules, PO daily for 6 months
Placebo capsules, PO daily for 6 months
Outcomes
Primary Outcome Measures
Proportion of Patients Entrained as Assessed by Urinary aMT6
Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four 48 hour periods , collected approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.
Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS
Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 3 on the Non-24 Clinical Response Scale (N24CRS). N24CRS measures improvement in sleep-wake measures and overall functioning (LQ-nTST, UQ-dTSD, MoST and CGI-C). Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).
LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline
For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203.
Secondary Outcome Measures
Proportion of Patients Entrained as Assessed by Urinary Cortisol
Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four 48 hour periods, approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.
Average Clinical Global Impression of Change (CGI-C)
CGI-C scores range from 1 (very much improved) to 7 (very much worse). The average post-randomization score was obtained for each patient by averaging the last 2 scheduled assessments (Day D112 and Day D183). Lower number indicates improvement.
Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 90 Minutes) and UQ-dTSD (≤ 90 Minutes)
The sleep/wake response represents measurement of the combined improvement in the nighttime sleep duration and daytime sleep duration. Individuals that have an improvement in nighttime sleep and daytime sleep, defined as an increase of 90 minutes or more in the lower quartile of subjective nighttime total sleep time (LQ-nTST) and a decrease of 90 minutes or more in the upper quartile of daytime total sleep duration (UQ-dTSD) are considered to be a responder.
Average Lower Quartile of Nights of Nighttime Total Sleep Time (LQ-nTST)
LQ-nTST measures the difference in average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) between the randomized phase (6 months)and the screening phase (~ 6 weeks). The higher number indicates improvement.
Average Upper Quartile of Days of Subjective Daytime Sleep Duration (UQ-dTSD)
UQ-dTSD measures the difference in average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) between the randomized phase (6 months) and the screening phase (~ 6 weeks). Lower number indicates improvement.
Average Midpoint of Sleep (MoST)
Midpoint of Sleep Timing (MoST) is the measurement of the average midpoint of sleep time relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average.
Number of Patients With a Treatment Emergent Adverse Event (Open Label Extension Phase Only)
Adverse events were recorded in the source documents from the time of the patient's informed consent signature until the end of the patient's study participation. An AE was defined as any untoward medical occurrence in a clinical investigation patient who does not necessarily have causal relationship with treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01163032
Brief Title
Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
Official Title
A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon Versus Placebo in Totally Blind Subjects With N24HSWD Followed by an OLE Phase
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder
Detailed Description
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals, primarily those without light perception, are unable to synchronize their endogenous circadian pacemaker to the 24-hour light-dark cycle, and the timing of their circadian rhythm instead reflects the intrinsic period of their endogenous circadian pacemaker. As a result, the circadian rhythm of sleep-wake propensity in these individuals moves gradually later and later each day if there circadian period is > 24 hours and earlier and earlier if < 24 hours. These individuals will be able to sleep well at night when their sleep-wake propensity rhythm is approximately aligned with the 24-hour light-dark and social cycle. However, after a short time, the endogenous sleep-wake propensity rhythm and the 24-hour light-dark cycle will move out of synchrony with each other, and they may have difficulty falling asleep until well into the night. In addition to problems sleeping at the desired time, the subjects experience daytime sleepiness and daytime napping.
This will be a multicenter, randomized, double-masked, placebo-controlled, parallel study. The study has two phases: the pre-randomization phase followed by either the randomization phase or the open-label extension (OLE). The pre-randomization phase comprises a screening visit where subject's initial eligibility will be evaluated, a circadian period (τ) estimation segment, and a variable-length in-phase transition segment in which subjects will wait to start treatment until their circadian phase is aligned with their target bedtime. Subjects that meet all entry criteria for the study will enter the randomization phase. During the randomization phase, subjects will be asked to take either 20 mg tasimelteon or placebo approximately 1 hour prior to their target bedtime for 26 weeks in a double-masked fashion. Subjects who have a τ greater than 24.0 and meet all entry criteria but that are ineligible for the randomization phase due to their τ estimate may be given the opportunity to participate in the OLE phase. During the OLE phase, subjects will take open-label 20mg tasimelteon for 26 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-24-Hour Sleep-Wake Disorder
Keywords
Blindness, Eye Diseases, Nap Disorders, Circadian Rhythm Disorders, Sleep disorders, Circadian Rhythm Sleep Disorders, Dyssomnias, Nervous System Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tasimelteon
Arm Type
Experimental
Arm Description
20 mg tasimelteon capsules, PO daily for 6 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules, PO daily for 6 months
Intervention Type
Drug
Intervention Name(s)
tasimelteon
Other Intervention Name(s)
VEC-162
Intervention Description
20 mg tasimelteon capsules, PO daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules, PO daily for 6 months
Primary Outcome Measure Information:
Title
Proportion of Patients Entrained as Assessed by Urinary aMT6
Description
Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four 48 hour periods , collected approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.
Time Frame
1 month
Title
Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS
Description
Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 3 on the Non-24 Clinical Response Scale (N24CRS). N24CRS measures improvement in sleep-wake measures and overall functioning (LQ-nTST, UQ-dTSD, MoST and CGI-C). Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).
LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline
For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of Patients Entrained as Assessed by Urinary Cortisol
Description
Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four 48 hour periods, approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.
Time Frame
1 month
Title
Average Clinical Global Impression of Change (CGI-C)
Description
CGI-C scores range from 1 (very much improved) to 7 (very much worse). The average post-randomization score was obtained for each patient by averaging the last 2 scheduled assessments (Day D112 and Day D183). Lower number indicates improvement.
Time Frame
Day 112 and 183
Title
Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 90 Minutes) and UQ-dTSD (≤ 90 Minutes)
Description
The sleep/wake response represents measurement of the combined improvement in the nighttime sleep duration and daytime sleep duration. Individuals that have an improvement in nighttime sleep and daytime sleep, defined as an increase of 90 minutes or more in the lower quartile of subjective nighttime total sleep time (LQ-nTST) and a decrease of 90 minutes or more in the upper quartile of daytime total sleep duration (UQ-dTSD) are considered to be a responder.
Time Frame
6 months
Title
Average Lower Quartile of Nights of Nighttime Total Sleep Time (LQ-nTST)
Description
LQ-nTST measures the difference in average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) between the randomized phase (6 months)and the screening phase (~ 6 weeks). The higher number indicates improvement.
Time Frame
6 months
Title
Average Upper Quartile of Days of Subjective Daytime Sleep Duration (UQ-dTSD)
Description
UQ-dTSD measures the difference in average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) between the randomized phase (6 months) and the screening phase (~ 6 weeks). Lower number indicates improvement.
Time Frame
6 months
Title
Average Midpoint of Sleep (MoST)
Description
Midpoint of Sleep Timing (MoST) is the measurement of the average midpoint of sleep time relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average.
Time Frame
6 months
Title
Number of Patients With a Treatment Emergent Adverse Event (Open Label Extension Phase Only)
Description
Adverse events were recorded in the source documents from the time of the patient's informed consent signature until the end of the patient's study participation. An AE was defined as any untoward medical occurrence in a clinical investigation patient who does not necessarily have causal relationship with treatment.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS
Description
Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 2 on the Non-24 Clinical Response Scale (N24CRS) which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).
LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline
For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203.
Time Frame
6 months
Title
Proportion of Patients With a Clinical Response (Score of ≥ 3 on N24CRS)
Description
Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).
LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline
Time Frame
6 months
Title
Proportion of Patients With a Clinical Response (Score of ≥ 2 on N24CRS)
Description
Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).
LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability and acceptance to provide informed consent;
No perception of light by the subject's own report;
Diagnosis of N24HSWD as determined by:
History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire and
Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.
Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
Fluent in English;
Exclusion Criteria:
Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;
History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study;
Unable to perform calls to the study IVR system to report questionnaire results;
Exposure to any investigational drug, including placebo, within 30 days or 5 half lives (whichever was longer) of screening;
Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle
Use of melatonin or melatonin agonist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Organizational Affiliation
Vanda Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Associates, PA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
SDS Clinical Trials Inc.
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
St. Johns Sleep Disorder Center - St. Johns Medical Plaza
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Radiant Research - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
PAB Clinical Research Inc.
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Kendall South Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Ocean Sleep Disorders Center - Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Sleep Disorders Center Of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Suburban Lung Associates SC (Chicago Metropolitan Area)
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
The Center for Sleep and Wake Disorders (Washington, D.C. Metropolitan Area)
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Michigan Head-Pain Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
St. Luke's Sleep Medicine and Research Center (St. Louis Metropolitan Area)
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Tri-State Sleep Disorders Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Ohio Sleep Medicine Institute (Columbus Metropolitan Area)
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma city
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Columbia Research Group Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Center For Sleep Medicine at Chestnut Hill Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States
Facility Name
Consolidated Clinical trials
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
SleepMed, Inc. - Columbia
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Todd J. Swick, M.D., P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Advanced Sleep Research GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Bergmannsheil University Hospital - Medical Clinic III
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Klinische-Forschung Hannover Mitte
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Universitaetsklinikum Glesen and Marburg gmbH/Schlaflabor - Sleep Lab University Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Bonomed Studiezentrum
City
Munich
ZIP/Postal Code
80331
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26466871
Citation
Lockley SW, Dressman MA, Licamele L, Xiao C, Fisher DM, Flynn-Evans EE, Hull JT, Torres R, Lavedan C, Polymeropoulos MH. Tasimelteon for non-24-hour sleep-wake disorder in totally blind people (SET and RESET): two multicentre, randomised, double-masked, placebo-controlled phase 3 trials. Lancet. 2015 Oct 31;386(10005):1754-64. doi: 10.1016/S0140-6736(15)60031-9. Epub 2015 Aug 4.
Results Reference
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Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
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