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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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ClinicalTrials.gov Identifier: NCT01163032
Recruitment Status : Completed
First Posted : July 15, 2010
Results First Posted : October 16, 2014
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Non-24-Hour Sleep-Wake Disorder
Interventions Drug: tasimelteon
Drug: Placebo
Enrollment 136
Recruitment Details *Various category for the Randomization Phase: 4 patients in each treatment group discontinued due to study termination by the sponsor and 1 patient in the tasimelteon group discontinued due to travel across multiple time zones
Pre-assignment Details  
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized) Open Label Tasimelteon
Hide Arm/Group Description

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Period Title: Randomization Phase
Started 42 42 0 [1]
Completed 32 30 0 [1]
Not Completed 10 12 0
Reason Not Completed
Withdrawal by Subject             2             3             0
Adverse Event             3             3             0
Protocol Violation             0             1             0
Various*             5             4             0
Unsatisfactory Therapeutic Effect             0             1             0
[1]
Not applicable for Randomized Phase
Period Title: Open Label Extension Phase
Started 0 [1] 0 [1] 55 [2]
Completed 0 [1] 0 [1] 39
Not Completed 0 0 16
Reason Not Completed
Adverse Event             0             0             3
Withdrawal by Subject             0             0             3
Protocol Violation             0             0             1
Study Termination             0             0             7
Unsatisfactory Therapeutic Effect             0             0             2
[1]
Not applicable for Open Label Extension Phase
[2]
3 randomized patients rolled into extension (2 randomized to tasimelteon and one to placebo)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized) Open Label Tasimelteon Total
Hide Arm/Group Description

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Total of all reporting groups
Overall Number of Baseline Participants 42 42 52 136
Hide Baseline Analysis Population Description
52 patients entered the OLE Phase from screening and 3 patients rolled over after completing the Randomization Phase (2:tasimelteon; 1:placebo). For this analysis, 3 patients are included in the randomized arms and not the OLE. A separate analysis has been done for both age and gender for the 3 subjects (Rand to OLE).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 52 participants 136 participants
50.8  (12.63) 50.7  (13.15) 50.37  (13.17) 50.6  (12.91)
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Rand to OLE Number Analyzed 42 participants 42 participants 52 participants 136 participants
42.00  (5.66) 54.00 [2]   (NA) NA  (NA) 46.00  (8.00)
[1]
Measure Description: N = 2 (tasimelteon randomized then went to OLE) and 1 (placebo randomized then went to OLE)
[2]
N = 1; Cannot be calculated
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 52 participants 136 participants
Rand to OLE (Female) 0 0 0 0
Rand to OLE (Male) 2 1 0 3
[1]
Measure Description: N = 2 (tasimelteon randomized then went to OLE) and 1 (placebo randomized then went to OLE)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 52 participants 136 participants
Female
18
  42.9%
17
  40.5%
25
  48.1%
60
  44.1%
Male
24
  57.1%
25
  59.5%
27
  51.9%
76
  55.9%
1.Primary Outcome
Title Proportion of Patients Entrained as Assessed by Urinary aMT6
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 40 38
Measure Type: Number
Unit of Measure: percentage of patients
20 2.6
2.Primary Outcome
Title Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Measure Type: Number
Unit of Measure: percentage of patients
23.7 0
3.Secondary Outcome
Title Proportion of Patients Entrained as Assessed by Urinary Cortisol
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 40 38
Measure Type: Number
Unit of Measure: percentage of patients
17.5 2.6
4.Secondary Outcome
Title Average Clinical Global Impression of Change (CGI-C)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Mean (Standard Error)
Unit of Measure: score
2.6  (0.20) 3.4  (0.21)
5.Secondary Outcome
Title Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 90 Minutes) and UQ-dTSD (≤ 90 Minutes)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Measure Type: Number
Unit of Measure: percentage of patients
13.2 2.9
6.Secondary Outcome
Title Average Lower Quartile of Nights of Nighttime Total Sleep Time (LQ-nTST)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Mean (Standard Error)
Unit of Measure: minutes
56.80  (9.305) 17.08  (9.702)
7.Secondary Outcome
Title Average Upper Quartile of Days of Subjective Daytime Sleep Duration (UQ-dTSD)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Mean (Standard Error)
Unit of Measure: minutes
-46.48  (6.595) -17.87  (6.889)
8.Secondary Outcome
Title Average Midpoint of Sleep (MoST)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Mean (Standard Error)
Unit of Measure: minutes
35.00  (5.313) 14.48  (5.547)
9.Secondary Outcome
Title Number of Patients With a Treatment Emergent Adverse Event (Open Label Extension Phase Only)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
One subject who rolled into the OLE from the randomized phase (tasimelteon) experienced an unrelated TEAE during the OLE phase.
Arm/Group Title Open Label Tasimelteon
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
37
10.Other Pre-specified Outcome
Title Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Measure Type: Number
Unit of Measure: percentage of patients
28.9 0
11.Other Pre-specified Outcome
Title Proportion of Patients With a Clinical Response (Score of ≥ 3 on N24CRS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Measure Type: Number
Unit of Measure: percentage of patients
28.9 2.9
12.Other Pre-specified Outcome
Title Proportion of Patients With a Clinical Response (Score of ≥ 2 on N24CRS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Measure Type: Number
Unit of Measure: percentage of patients
57.9 20.6
13.Post-Hoc Outcome
Title Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 45 Minutes) and UQ-dTSD (≤ 45 Minutes)
Hide Description Responder analysis with responder defined as an increase of 45 minutes or more in (LQ-nTST) and a decrease of 45 minutes or more in (UQ-dTSD).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized)
Hide Arm/Group Description:

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

Overall Number of Participants Analyzed 38 34
Measure Type: Number
Unit of Measure: percentage of patients
31.6 8.8
Time Frame 1st dose to 30 days following last administration of study treatment
Adverse Event Reporting Description 55 subjects enrolled into the Open Label phase (including 3 randomized subjects who rolled into the OLE). One subject enrolled in the Open Label phase but did not take any study drug.
 
Arm/Group Title Tasimelteon (Randomized) Placebo (Randomized) Open Label Tasimelteon
Hide Arm/Group Description

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

Placebo capsules, PO daily for 6 months

Placebo: Placebo capsules, PO daily for 6 months

20 mg tasimelteon capsules, PO daily for 6 months

tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months

All-Cause Mortality
Tasimelteon (Randomized) Placebo (Randomized) Open Label Tasimelteon
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Tasimelteon (Randomized) Placebo (Randomized) Open Label Tasimelteon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/42 (9.52%)      2/42 (4.76%)      2/54 (3.70%)    
Gastrointestinal disorders       
Small Intestinal Obstruction  1  0/42 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  1  1/42 (2.38%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Infections and infestations       
Diverticulitis  1  1/42 (2.38%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Injury, poisoning and procedural complications       
Procedural Pain  1  0/42 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute Lymphocytic Leukaemia  1  1/42 (2.38%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Nervous system disorders       
Syncope  1  1/42 (2.38%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Serotonin Syndrome  1  0/42 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Transient Ischaemic Attack  1  0/42 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tasimelteon (Randomized) Placebo (Randomized) Open Label Tasimelteon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/42 (47.62%)      13/42 (30.95%)      21/54 (38.89%)    
Gastrointestinal disorders       
Nausea  1  1/42 (2.38%)  1 3/42 (7.14%)  3 0/54 (0.00%)  0
General disorders       
Oedema peripheral  1  3/42 (7.14%)  3 2/42 (4.76%)  2 0/54 (0.00%)  0
Infections and infestations       
Nasopharyngitis  1  3/42 (7.14%)  3 4/42 (9.52%)  4 5/54 (9.26%)  6
Urinary tract infection  1  3/42 (7.14%)  3 1/42 (2.38%)  1 5/54 (9.26%)  6
Upper respiratory tract infection  1  3/42 (7.14%)  3 0/42 (0.00%)  0 2/54 (3.70%)  2
Investigations       
Alanine aminotransferase increased  1  4/42 (9.52%)  4 2/42 (4.76%)  2 2/54 (3.70%)  2
Asparate aminotransferase increased  1  3/42 (7.14%)  3 2/42 (4.76%)  2 3/54 (5.56%)  3
Gamma-glutamyltransferase increased  1  0/42 (0.00%)  0 2/42 (4.76%)  2 3/54 (5.56%)  3
Nervous system disorders       
Headache  1  7/42 (16.67%)  11 3/42 (7.14%)  3 4/54 (7.41%)  4
Psychiatric disorders       
Abnormal dreams  1  2/42 (4.76%)  2 0/42 (0.00%)  0 3/54 (5.56%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marlene Dressman, Ph.D.
Organization: Vanda Pharmaceuticals Inc.
Phone: 202-734-3462
EMail: marlene.dressman@vandapharma.com
Layout table for additonal information
Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01163032    
Other Study ID Numbers: VP-VEC-162-3201
First Submitted: July 2, 2010
First Posted: July 15, 2010
Results First Submitted: August 8, 2014
Results First Posted: October 16, 2014
Last Update Posted: October 16, 2014