RESTORA 1: Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
Sponsor
Midnight Pharma, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00608985
Collaborator
(none)
709
91
4
20
7.8
0.4
Study Details
Study Description
Brief Summary
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
709 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia
Study Start Date
:
Mar 1, 2008
Actual Primary Completion Date
:
Sep 1, 2009
Actual Study Completion Date
:
Nov 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 almorexant 200 mg |
Drug: almorexant
2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
| Experimental: 2 almorexant 100 mg |
Drug: almorexant
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
| Placebo Comparator: 3 Placebo |
Drug: Placebo
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
| Active Comparator: 4 zolpidem 10 mg |
Drug: zolpidem
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) [From baseline to Day 1&2]
WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16
- Change From Baseline to Day 15&16 in WASO [From baseline to Day 15&16]
WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16
- Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) [From baseline to Week 1&2]
sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2
Secondary Outcome Measures
- Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) [From baseline to Day 1&2]
LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
- Change From Baseline to Day 15&16 in LPS [From baseline to Day 15&16]
LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
- Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) [From baseline to Week 1&2]
sLSO was the self-reported time to fall asleep as reported in the sleep diary
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Adult subjects (18-64 years) with a diagnosis of primary insomnia.
Exclusion Criteria:
-
History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sleep Disorders Laboratory, Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 2 | Monash Adult Sleep Center, Monash Medical Centre | Clayton | Victoria | Australia | 3168 |
| 3 | Western Hospitpal, Private Bag | Footscray | Victoria | Australia | 3011 |
| 4 | Institute for Breathing and Sleep (IBAS) | Heidelburg | Victoria | Australia | 3084 |
| 5 | The Woolcock Institute of Medical Research | Glebe | Australia | 2050 | |
| 6 | Australian Clinical Research Organisation | Kippa Ring | Australia | 4021 | |
| 7 | Melbourne Sleep Disorder Centre | Melbourne | Australia | ||
| 8 | Burnside Hospital Clinical Trials Centre | Toorak Gardens | Australia | 5065 | |
| 9 | Westmead Hospital, Department of Respiratory | Westmead | Australia | 2145 | |
| 10 | Medical University of Innsbruck, Department of Neurology | Innsbruck | Austria | ||
| 11 | Rudolfinerhaus | Vienna | Austria | A-1090 | |
| 12 | University of Vienna - Department of Neurology | Vienna | Austria | A-1090 | |
| 13 | Cliniques Universitaires Saint Luc | Brussels | Belgium | ||
| 14 | CH Jolimont / Sleep Disorders Center, Hospital de Jolimont | Haine Saint Paul | Belgium | ||
| 15 | Clinique Andre Vesale | Montigny le Tilleuil | Belgium | ||
| 16 | Hospital St. Naum, Paediatr. Neurology | Sofia | Bulgaria | ||
| 17 | MHAT 'St. Marina' | Varna | Bulgaria | ||
| 18 | Oddeleni nasledne pece, Nemocnice Ceske Budejovice | Ceske Budejovice | Czech Republic | ||
| 19 | Centrum pro poruchy spanku a bdeni, Neurologicka klinika | Katerinska | Czech Republic | ||
| 20 | Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY | Ostava-Poruba | Czech Republic | ||
| 21 | Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o. | Prague | Czech Republic | ||
| 22 | Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie | Trutnov | Czech Republic | ||
| 23 | Scansleep Aps, Sovnlaegecentret | Arhus | Denmark | ||
| 24 | Sovnlagecentret - Scan Sleep | Copenhagen | Denmark | 1364 | |
| 25 | Scan Sleep ApS, Sovnlaegecentret | Copenhagen | Denmark | ||
| 26 | Tutkimuskeskus Vitalmed | Helsinki | Finland | ||
| 27 | Unesta Research Center | Tampere | Finland | ||
| 28 | University of Turku, Sleep Research Unit | Turku | Finland | ||
| 29 | Hopital Pellegrin | Bordeaux | France | ||
| 30 | Hopital Raymond Poincare | Garches | France | ||
| 31 | Service de Neurologie B, Hopital Gui de Chauliac | Montpellier | France | ||
| 32 | Hopital Pitie-Salpetriere | Paris | France | 75651 | |
| 33 | Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris | Paris | France | ||
| 34 | Federation des Pathologies du Sommeil | Paris | France | ||
| 35 | Advanced Sleep Research GmbH | Berlin | Germany | ||
| 36 | Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie | Berlin | Germany | ||
| 37 | ClinPharm International GmbH Berlin | Berlin | Germany | ||
| 38 | Klinische Forschung Berlin GmbH | Berlin | Germany | ||
| 39 | St. Hedwig-Krnkenhaus | Berlin | Germany | ||
| 40 | ClinPharm International GmbH Bochum | Bochum | Germany | ||
| 41 | ClinPharm International GmbH Chemnitz | Chemnitz | Germany | ||
| 42 | ClinPharm International GmbH Dresden | Dresden | Germany | ||
| 43 | ClinPharm International GmbH Frankfurt | Frankfurt | Germany | ||
| 44 | Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg | Freiburg | Germany | ||
| 45 | ClinPharm International GmbH Gorlitz | Gorlitz | Germany | ||
| 46 | Klinische Forschung | Hamburg | Germany | ||
| 47 | ClinPharm International GmbH Leipzig | Leipzig | Germany | ||
| 48 | ClinPharm International GmbH Magdeburg | Magdeburg | Germany | ||
| 49 | Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH | Marburg | Germany | ||
| 50 | ClinPharm International GmbH Potsdam | Potsdam | Germany | ||
| 51 | Klinik und Poliklinik fur Psychiatre | Regensburg | Germany | ||
| 52 | Klinische Forschung Schwerin GmbH | Schwerin | Germany | ||
| 53 | SOMNIBENE Institut fur Medizinische | Schwerin | Germany | ||
| 54 | Sleep Disorder Centre, State Health Centre | Budapest | Hungary | H-1134 | |
| 55 | Department of Neurology , University of Debrecen | Debrecen | Hungary | ||
| 56 | Dept of Neurology, University of Pecs | Pecs | Hungary | ||
| 57 | Sleep Laboratory, Ilnd Hospital | Szeged | Hungary | J-6725 | |
| 58 | Soroka University Medical Center, Unit for Sleep Research | Beer Sheva | Israel | 84101 | |
| 59 | Technion Sleep Medicine Center, Rambam Medical Center | Haifa | Israel | 31096 | |
| 60 | IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia | Bologna | Italy | IT-27100 | |
| 61 | IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno | Milan | Italy | 20127 | |
| 62 | Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa | Pisa | Italy | IT-56126 | |
| 63 | Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG | Gdansk | Poland | 890-952 | |
| 64 | Laboratorium Diagnostyka Snu, Pro-Medica | Krakow | Poland | 30-002 | |
| 65 | Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu | Lodz | Poland | 92-215 | |
| 66 | Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej | Warsaw | Poland | 02957 | |
| 67 | Laboratorium Diagnostyka Snu, Pro-Medica | Warszawa | Poland | 04-730 | |
| 68 | EMC Instytut Medyczny S.A | Wroclaw | Poland | 50-220 | |
| 69 | I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto | Bratislava | Slovakia | 81369 | |
| 70 | Neurologicka klinika, FN L. Pasteura Kosice | Kosice | Slovakia | 04066 | |
| 71 | BenMed Park Clinic | Benoni | Johannesburg | South Africa | |
| 72 | WITS Sleep Laboratory School of Physiology | Parktown | Johannesburg | South Africa | |
| 73 | Gatesville Medical Centre | Gatesville | Western Cape | South Africa | |
| 74 | Little Company of Mary Hospital | Pretoria | South Africa | ||
| 75 | Somerset West Trial Centre | Somerset West | South Africa | ||
| 76 | Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica | Barcelona | Spain | E-08025 | |
| 77 | Instituto de Investigaciones del Sueno | Madrid | Spain | 28036 | |
| 78 | Hospital Son Dureta, Unidad de Psicologia | Palma de Mallorca | Spain | 07014 | |
| 79 | Hospital La Fe, Unidad de Neurofisiologi | Valencia | Spain | 46009 | |
| 80 | Hospital MAZ, Unidad de Neurofisiologia y Sueno | Zaragoza | Spain | 50015 | |
| 81 | Carlanderska Sömnlaboratoriet | Goteborg | Sweden | SE-144 35 | |
| 82 | Örebro University Hospital, Neurology department Sleep Unit | Orebro | Sweden | ||
| 83 | Aleris Fysiologlab | Stockholm | Sweden | ||
| 84 | Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology | Basel | Switzerland | CH-4025 | |
| 85 | Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee | Chene-Bourg | Switzerland | CH-1225 | |
| 86 | KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna | Lucerne | Switzerland | CH-6006 | |
| 87 | University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine | Zurich | Switzerland | CH-8091 | |
| 88 | KSM Zurzach Klinik fur Schlafmedizin | Zurzach | Switzerland | CH-5330 | |
| 89 | National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II | Kiev | Ukraine | ||
| 90 | The Edinburgh Sleep Centre | Edinburgh | United Kingdom | ||
| 91 | The London Sleep Centre | London | United Kingdom |
Sponsors and Collaborators
- Midnight Pharma, LLC
Investigators
- Study Chair: Raymond Cluydts, Dr., Cognitive and Biological Psychology, University of Brussels
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Midnight Pharma, LLC
ClinicalTrials.gov Identifier:
NCT00608985
Other Study ID Numbers:
- AC-057A301
First Posted:
Feb 6, 2008
Last Update Posted:
Mar 14, 2016
Last Verified:
Feb 1, 2016
Keywords provided by Midnight Pharma, LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | First subject, first visit was on 28 April 2008. The last subject, last visit (safety follow-up) was on 30 September 2009. |
|---|---|
| Pre-assignment Detail | There was a screening period of 14 to 28 days. Two randomized subjects (one in each almorexant (ACT-078573) dose group) did not receive double-blind study treatment. The 'Started population' was defined as those participants who were randomized and treated. |
| Arm/Group Title | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
| Period Title: Overall Study | ||||
| STARTED | 177 | 186 | 176 | 168 |
| Completed Double-blind Treatment | 163 | 174 | 171 | 161 |
| COMPLETED | 161 | 173 | 170 | 159 |
| NOT COMPLETED | 16 | 13 | 6 | 9 |
Baseline Characteristics
| Arm/Group Title | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated | Total of all reporting groups |
| Overall Participants | 177 | 186 | 176 | 168 | 707 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
177
100%
|
186
100%
|
176
100%
|
168
100%
|
707
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
46.2
(11.69)
|
44.1
(12.44)
|
46.1
(11.83)
|
45.1
(12.11)
|
45.4
(12.03)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
111
62.7%
|
113
60.8%
|
106
60.2%
|
106
63.1%
|
436
61.7%
|
| Male |
66
37.3%
|
73
39.2%
|
70
39.8%
|
62
36.9%
|
271
38.3%
|
| Region of Enrollment (participants) [Number] | |||||
| Australia |
13
7.3%
|
15
8.1%
|
12
6.8%
|
14
8.3%
|
54
7.6%
|
| Austria |
3
1.7%
|
5
2.7%
|
2
1.1%
|
4
2.4%
|
14
2%
|
| Belgium |
0
0%
|
1
0.5%
|
1
0.6%
|
0
0%
|
2
0.3%
|
| Bulgaria |
1
0.6%
|
0
0%
|
1
0.6%
|
0
0%
|
2
0.3%
|
| Czech Republic |
2
1.1%
|
2
1.1%
|
1
0.6%
|
1
0.6%
|
6
0.8%
|
| Denmark |
6
3.4%
|
5
2.7%
|
5
2.8%
|
4
2.4%
|
20
2.8%
|
| Finland |
13
7.3%
|
14
7.5%
|
13
7.4%
|
14
8.3%
|
54
7.6%
|
| France |
3
1.7%
|
2
1.1%
|
3
1.7%
|
2
1.2%
|
10
1.4%
|
| Germany |
83
46.9%
|
86
46.2%
|
87
49.4%
|
81
48.2%
|
337
47.7%
|
| Hungary |
12
6.8%
|
11
5.9%
|
11
6.3%
|
13
7.7%
|
47
6.6%
|
| Israel |
5
2.8%
|
5
2.7%
|
6
3.4%
|
5
3%
|
21
3%
|
| Italy |
3
1.7%
|
3
1.6%
|
2
1.1%
|
2
1.2%
|
10
1.4%
|
| Poland |
3
1.7%
|
3
1.6%
|
3
1.7%
|
3
1.8%
|
12
1.7%
|
| South Africa |
15
8.5%
|
13
7%
|
13
7.4%
|
12
7.1%
|
53
7.5%
|
| Spain |
4
2.3%
|
6
3.2%
|
5
2.8%
|
3
1.8%
|
18
2.5%
|
| Sweden |
6
3.4%
|
8
4.3%
|
5
2.8%
|
6
3.6%
|
25
3.5%
|
| Switzerland |
1
0.6%
|
4
2.2%
|
4
2.3%
|
1
0.6%
|
10
1.4%
|
| United Kingdom |
4
2.3%
|
3
1.6%
|
2
1.1%
|
3
1.8%
|
12
1.7%
|
Outcome Measures
| Title | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) |
|---|---|
| Description | WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16 |
| Time Frame | From baseline to Day 1&2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated patients |
| Arm/Group Title | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
| Measure Participants | 177 | 186 | 176 | 168 |
| Baseline |
85.0
(39.81)
|
86.6
(39.17)
|
92.3
(35.92)
|
76.5
(36.95)
|
| Day 1&2 |
72.8
(42.63)
|
54.5
(37.65)
|
46.4
(28.85)
|
54.6
(36.05)
|
| Change from baseline to day 1&2 |
-11.8
(38.73)
|
-29.0
(31.50)
|
-40.4
(31.70)
|
-17.9
(29.19)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 100mg |
|---|---|---|
| Comments | Change from baseline to day 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -15.0 | |
| Confidence Interval |
(2-Sided) 95% -21.8 to -8.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 200mg |
|---|---|---|
| Comments | Change from baseline to day 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -26.8 | |
| Confidence Interval |
(2-Sided) 95% -34.3 to -19.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Zolpidem 10mg |
|---|---|---|
| Comments | Change from baseline to day 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0376 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -6.8 | |
| Confidence Interval |
(2-Sided) 95% -13.5 to -0.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline to Day 15&16 in WASO |
|---|---|
| Description | WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16 |
| Time Frame | From baseline to Day 15&16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated patients |
| Arm/Group Title | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
| Measure Participants | 177 | 186 | 176 | 168 |
| Baseline |
85.0
(39.81)
|
86.6
(39.17)
|
92.3
(35.92)
|
76.5
(36.95)
|
| Day 15&16 |
65.0
(45.90)
|
55.8
(35.07)
|
51.8
(31.31)
|
63.0
(42.31)
|
| Change from baseline to Day 15&16 |
-18.3
(43.40)
|
-29.6
(33.12)
|
-36.3
(35.20)
|
-15.1
(36.61)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 100mg |
|---|---|---|
| Comments | Change from baseline to day 15&16 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -13.5 | |
| Confidence Interval |
(2-Sided) 95% -20.3 to -6.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 200mg |
|---|---|---|
| Comments | Change from baseline to day 15&16 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -19.5 | |
| Confidence Interval |
(2-Sided) 95% -27.3 to -12.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Zolpidem 10mg |
|---|---|---|
| Comments | Change from baseline to day 15&16 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3358 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | 3.5 | |
| Confidence Interval |
(2-Sided) 95% -3.8 to 11.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) |
|---|---|
| Description | sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2 |
| Time Frame | From baseline to Week 1&2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated patients with available data |
| Arm/Group Title | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
| Measure Participants | 175 | 179 | 173 | 168 |
| Baseline |
64.0
(51.32)
|
65.0
(60.49)
|
69.0
(46.68)
|
61.6
(48.29)
|
| Week 1&2 |
52.9
(48.33)
|
40.5
(50.87)
|
42.9
(42.06)
|
30.5
(42.26)
|
| Change from baseline to week 1&2 |
-14.1
(31.84)
|
-19.5
(36.93)
|
-21.8
(32.5)
|
-23.4
(33.22)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 100mg |
|---|---|---|
| Comments | Change from baseline to week 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0186 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -7.3 | |
| Confidence Interval |
(2-Sided) 95% -13.3 to -1.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 200mg |
|---|---|---|
| Comments | Change from baseline to week 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -10.4 | |
| Confidence Interval |
(2-Sided) 95% -16.4 to -4.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Zolpidem 10mg |
|---|---|---|
| Comments | Change from baseline to week 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -12.7 | |
| Confidence Interval |
(2-Sided) 95% -18.8 to -6.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) |
|---|---|
| Description | LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG |
| Time Frame | From baseline to Day 1&2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated patients |
| Arm/Group Title | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
| Measure Participants | 177 | 186 | 176 | 168 |
| Baseline |
57.3
(41.81)
|
57.4
(37.03)
|
54.1
(32.89)
|
56.5
(34.60)
|
| Day 1&2 |
37.5
(34.64)
|
28.8
(30.13)
|
25.0
(21.97)
|
22.5
(27.25)
|
| Change from baseline to day 1&2 |
-15.8
(40.21)
|
-24.8
(37.00)
|
-22.5
(30.83)
|
-29.4
(34.63)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 100mg |
|---|---|---|
| Comments | Change from baseline to day 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0035 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -9.3 | |
| Confidence Interval |
(2-Sided) 95% -15.3 to -3.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 200mg |
|---|---|---|
| Comments | Change from baseline to day 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -9.5 | |
| Confidence Interval |
(2-Sided) 95% -15.0 to -4.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Zolpidem 10mg |
|---|---|---|
| Comments | Change from baseline to day 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -16.0 | |
| Confidence Interval |
(2-Sided) 95% -22.0 to -9.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline to Day 15&16 in LPS |
|---|---|
| Description | LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG |
| Time Frame | From baseline to Day 15&16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated patients |
| Arm/Group Title | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
| Measure Participants | 177 | 186 | 176 | 168 |
| Baseline |
57.3
(41.81)
|
57.4
(37.03)
|
54.1
(32.89)
|
56.5
(34.60)
|
| Day 15&16 |
30.0
(35.33)
|
29.3
(28.51)
|
24.1
(22.48)
|
24.6
(25.62)
|
| Change from baseline to day 15&16 |
-20.0
(46.10)
|
-23.5
(35.90)
|
-26.5
(31.10)
|
-32.3
(34.19)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 100mg |
|---|---|---|
| Comments | Change from baseline to day 15&16 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2237 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -4.0 | |
| Confidence Interval |
(2-Sided) 95% -11.0 to 2.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 200mg |
|---|---|---|
| Comments | Change from baseline to day 15&16 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0607 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -6.0 | |
| Confidence Interval |
(2-Sided) 95% -12.3 to 0.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Zolpidem 10mg |
|---|---|---|
| Comments | Change from baseline to day 15&16 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0017 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -10.5 | |
| Confidence Interval |
(2-Sided) 95% -17.3 to -4.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) |
|---|---|
| Description | sLSO was the self-reported time to fall asleep as reported in the sleep diary |
| Time Frame | From baseline to Week 1&2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated patients with available data |
| Arm/Group Title | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
| Measure Participants | 175 | 179 | 173 | 168 |
| Baseline |
58.8
(33.68)
|
55.0
(50.70)
|
53.3
(27.93)
|
50.5
(29.34)
|
| Week 1&2 |
45.0
(31.61)
|
36.5
(40.64)
|
34.5
(21.56)
|
33.3
(21.50)
|
| Change from baseline to week 1&2 |
-10.0
(26.89)
|
-16.2
(34.48)
|
-16.2
(23.22)
|
-17.2
(25.67)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 100mg |
|---|---|---|
| Comments | Change from baseline to week 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1187 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -4.1 | |
| Confidence Interval |
(2-Sided) 95% -9.1 to 0.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Almorexant 200mg |
|---|---|---|
| Comments | Change from baseline to week 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0017 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -7.1 | |
| Confidence Interval |
(2-Sided) 95% -11.5 to -2.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Zolpidem 10mg |
|---|---|---|
| Comments | Change from baseline to week 1&2 compared with placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0121 |
| Comments | ||
| Method | Wilcoxon rank-sum | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -6.1 | |
| Confidence Interval |
(2-Sided) 95% -10.8 to -1.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg | ||||
| Arm/Group Description | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated | ||||
All Cause Mortality |
||||||||
| Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/177 (0%) | 2/186 (1.1%) | 1/176 (0.6%) | 0/168 (0%) | ||||
| Infections and infestations | ||||||||
| ABSCESS LIMB | 0/177 (0%) | 0 | 1/186 (0.5%) | 1 | 0/176 (0%) | 0 | 0/168 (0%) | 0 |
| Nervous system disorders | ||||||||
| MULTIPLE SCLEROSIS | 0/177 (0%) | 0 | 1/186 (0.5%) | 1 | 0/176 (0%) | 0 | 0/168 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| CALCULUS URETERIC | 0/177 (0%) | 0 | 0/186 (0%) | 0 | 1/176 (0.6%) | 1 | 0/168 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 64/177 (36.2%) | 65/186 (34.9%) | 61/176 (34.7%) | 72/168 (42.9%) | ||||
| Cardiac disorders | ||||||||
| PALPITATIONS | 1/177 (0.6%) | 1/186 (0.5%) | 1/176 (0.6%) | 2/168 (1.2%) | ||||
| Ear and labyrinth disorders | ||||||||
| VERTIGO | 0/177 (0%) | 1/186 (0.5%) | 1/176 (0.6%) | 2/168 (1.2%) | ||||
| Eye disorders | ||||||||
| BLEPHAROSPASM | 0/177 (0%) | 0/186 (0%) | 2/176 (1.1%) | 0/168 (0%) | ||||
| VISION BLURRED | 3/177 (1.7%) | 0/186 (0%) | 1/176 (0.6%) | 1/168 (0.6%) | ||||
| Gastrointestinal disorders | ||||||||
| NAUSEA | 7/177 (4%) | 4/186 (2.2%) | 6/176 (3.4%) | 4/168 (2.4%) | ||||
| DIARRHOEA | 1/177 (0.6%) | 6/186 (3.2%) | 1/176 (0.6%) | 2/168 (1.2%) | ||||
| ABDOMINAL PAIN UPPER | 3/177 (1.7%) | 3/186 (1.6%) | 2/176 (1.1%) | 1/168 (0.6%) | ||||
| CONSTIPATION | 0/177 (0%) | 2/186 (1.1%) | 0/176 (0%) | 0/168 (0%) | ||||
| DRY MOUTH | 1/177 (0.6%) | 1/186 (0.5%) | 0/176 (0%) | 3/168 (1.8%) | ||||
| DYSPEPSIA | 2/177 (1.1%) | 0/186 (0%) | 1/176 (0.6%) | 1/168 (0.6%) | ||||
| General disorders | ||||||||
| FATIGUE | 2/177 (1.1%) | 9/186 (4.8%) | 6/176 (3.4%) | 6/168 (3.6%) | ||||
| ASTHENIA | 2/177 (1.1%) | 5/186 (2.7%) | 3/176 (1.7%) | 1/168 (0.6%) | ||||
| CHEST DISCOMFORT | 1/177 (0.6%) | 1/186 (0.5%) | 1/176 (0.6%) | 1/168 (0.6%) | ||||
| Infections and infestations | ||||||||
| NASOPHARYNGITIS | 3/177 (1.7%) | 5/186 (2.7%) | 2/176 (1.1%) | 5/168 (3%) | ||||
| INFLUENZA | 0/177 (0%) | 2/186 (1.1%) | 0/176 (0%) | 0/168 (0%) | ||||
| Investigations | ||||||||
| WEIGHT INCREASED | 0/177 (0%) | 0/186 (0%) | 3/176 (1.7%) | 1/168 (0.6%) | ||||
| Metabolism and nutrition disorders | ||||||||
| FOOD CRAVING | 0/177 (0%) | 0/186 (0%) | 2/176 (1.1%) | 0/168 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| MUSCLE SPASMS | 2/177 (1.1%) | 1/186 (0.5%) | 1/176 (0.6%) | 0/168 (0%) | ||||
| Nervous system disorders | ||||||||
| HEADACHE | 21/177 (11.9%) | 18/186 (9.7%) | 26/176 (14.8%) | 29/168 (17.3%) | ||||
| DIZZINESS | 10/177 (5.6%) | 6/186 (3.2%) | 8/176 (4.5%) | 3/168 (1.8%) | ||||
| SOMNOLENCE | 4/177 (2.3%) | 6/186 (3.2%) | 5/176 (2.8%) | 4/168 (2.4%) | ||||
| BALANCE DISORDER | 0/177 (0%) | 1/186 (0.5%) | 2/176 (1.1%) | 2/168 (1.2%) | ||||
| DYSGEUSIA | 1/177 (0.6%) | 1/186 (0.5%) | 1/176 (0.6%) | 3/168 (1.8%) | ||||
| PARAESTHESIA | 2/177 (1.1%) | 1/186 (0.5%) | 1/176 (0.6%) | 2/168 (1.2%) | ||||
| Psychiatric disorders | ||||||||
| DEPRESSED MOOD | 0/177 (0%) | 2/186 (1.1%) | 1/176 (0.6%) | 3/168 (1.8%) | ||||
| CONFUSIONAL STATE | 1/177 (0.6%) | 1/186 (0.5%) | 1/176 (0.6%) | 2/168 (1.2%) | ||||
| NIGHTMARE | 2/177 (1.1%) | 0/186 (0%) | 2/176 (1.1%) | 1/168 (0.6%) | ||||
| ANXIETY | 0/177 (0%) | 1/186 (0.5%) | 1/176 (0.6%) | 2/168 (1.2%) | ||||
| RESTLESSNESS | 0/177 (0%) | 0/186 (0%) | 2/176 (1.1%) | 0/168 (0%) | ||||
| Renal and urinary disorders | ||||||||
| MICTURITION URGENCY | 0/177 (0%) | 1/186 (0.5%) | 1/176 (0.6%) | 0/168 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| OROPHARYNGEAL PAIN | 1/177 (0.6%) | 2/186 (1.1%) | 0/176 (0%) | 2/168 (1.2%) | ||||
| COUGH | 1/177 (0.6%) | 0/186 (0%) | 1/176 (0.6%) | 2/168 (1.2%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Ouali Berkani/Clinical Trial Leader |
|---|---|
| Organization | Actelion Pharmaceuticals Ltd |
| Phone | +41 61 565 5342 |
Responsible Party:
Midnight Pharma, LLC
ClinicalTrials.gov Identifier:
NCT00608985
Other Study ID Numbers:
- AC-057A301
First Posted:
Feb 6, 2008
Last Update Posted:
Mar 14, 2016
Last Verified:
Feb 1, 2016