|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
25 September 2012 |
|
Main ID: |
EUCTR2010-018414-69-IT |
|
Date of registration:
|
08/06/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
|
|
Scientific title:
|
A Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients with Primary Insomnia- Study B - ND |
|
Date of first enrolment:
|
19/07/2010 |
|
Target sample size:
|
945 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018414-69 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Denmark
|
Finland
|
Germany
|
Italy
|
Spain
|
Sweden
|
United Kingdom
| |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Patient is male or female and =18 years of age on the day of signing informed consent. 2. Patient has a DSM-IV-TR (Appendix 6.2) diagnosis of Primary Insomnia based on the investigator’s judgment and the patient’s sleep history as assessed on the Sleep Diagnostic Interview/Sleep History. 3. For a patient =65 years of age, (s)he scores =25 on the Mini Mental State Examination (MMSE) 4. A female patient who is of reproductive potential has a serum ß-hCG level consistent with the nongravid state at Screening Visit 1 and agrees to use acceptable contraception. Acceptable contraception is defined as abstinence (where abstinence is a locally accepted form of contraception) or use of 2 regionally accepted effective forms of contraception including: partner using condom with spermicide or status post vasectomy, and patient using hormonal contraceptives, intra-uterine device (IUD), diaphragm with spermicide, contraceptive sponge. Note that if a male partner does not use an effective form of contraception, a female patient MUST use 2 acceptable forms of contraception to satisfy the study requirement. 5. Patient reports total sleep time of < 6.5 hours on at least 3 out of 7 nights each week during the 4 weeks prior to Visit 1. 6. Patient reports sleep latency of = 30 minutes on at least 3 out of 7 nights each week during the 4 weeks prior to Visit 1. 7. Patient reports = 1 hour of wakefulness after sleep onset on at least 3 out of 7 nights each week during the 4 weeks prior to Visit 1. 8. Patient reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights each week during the 4 weeks prior to Visit 1. 9. The patient’s regular bedtime is between 9 pm (21:00) and 1 am (01:00). 10. During the study, patient is willing to limit alcohol to 2 drinks a day and at least 3 hours before going to bed. (A drink is defined as a 12 ounce bottle/can of beer (~14 grams alcohol) or a 4-ounce glass of wine (~12 grams alcohol) or 1 ounce of liquor (80 proof or 40 % alcohol, ~9 grams alcohol)). 11. During the study, the patient is willing to limit caffeine consumption to = 5 standard 6-ounce cups of caffeinated beverages a day, or = 600 mg caffeine, avoid caffeine after 4 pm (16:00) 12. Patient demonstrates compliance with the morning and evening diary for the period between Visit 2 and 3. Diary compliance is defined as patient having completed at least 70% [e.g. 5 out of 7 days/nights] of both the morning and evening diaries.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1.a Patient has a history or diagnosis of any of the following conditions, in the opinion of the investigator: • Narcolepsy • Cataplexy (familial or idiopathic) • Circadian Rhythm Sleep Disorder • Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and REM behavior disorder • Sleep-related Breathing Disorder (i.e., obstructive or central sleep apnea syndrome or central alveolar hypoventilation syndrome) • Periodic Limb Movement Disorder • Restless Legs Syndrome • Primary Hypersomnia • Excessive Daytime Sleepiness (EDS), not attributable to Primary Insomnia 1.b In the opinion of the investigator, patient has difficulty sleeping due to a confounding medical condition. NOTE: “Medical Conditions” may include chronic pain syndromes, chronic migraine, cardiac disease, nocturia (> 3 times/night), asthma, gastroesophageal reflux disease (GERD), or hot flashes. 1.c Patient has any history of a neurological disorder, including but not limited to seizure disorder (other than single episodes of childhood febrile seizures), stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness within the last 10 years). 1.d Patient has any of the following: • Lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder; or • A psychiatric condition requiring treatment with a prohibited medication; or, • Other psychiatric condition that, in the investigator`s opinion, would interfere with the patient`s ability to participate in the study. 1.e Patient has evidence of ongoing major depression (per MINI), significant depressive symptoms (e.g., a score = 20 on the Quick Inventory of Depressive Symptomatology – Self Report Scale (QIDS-SR16) or suicidal ideation (i.e., scores = 2 on the QIDS-SR16 suicide item #12) or, in the investigator`s opinion, is unable to complete the study procedures in a safe and appropriate fashion (regardless of QIDS-SR16 score). 1.f Patient has a history of substance abuse or dependence (EXCEPTION: patient is currently in sustained full remission for at least one year or meets criteria for early full remission, according to DSM-IV-TR). Substances include alcohol, marijuana, hypnotics, other prescription drugs, and drugs of abuse, but exclude nicotine dependence. A patient who fulfills DSM-IV-TR criteria for sustained remission can be included if he/she, in the investigator’s opinion, is at low risk for further drug dependence or abuse. 1.g Patient has either a history within the past 6 months prior to the Prestudy visit or current evidence of an unstable or clinically significant cardiovascular disorder, including but not limited to: • Acute coronary syndrome • Unstable angina • Congestive heart failure • Cardiogenic syncope • Cardiomyopathy • Any symptomatic arrhythmia 1.h Patient has abnormal pre-randomization laboratory values per the guidance below or other clinically significant, unexplained laboratory abnormality in the opinion of the investigator: • Alanine transaminase (SGPT or ALT) > 1.5 x the upper limit of normal (x ULN) • Aspartate transaminase (SGOT or AST) > 1.5 x ULN • Total bilirubin > 1.5 x ULN • Serum Creatinine of > 2 mg/dL 1.i Patient has a positive screening urine drug screen (e.g., positive for benzodiazepines, cannabinoids, cocaine, etc.). NOTE: The screen may be repeated at investigator`s discretion and as warranted by
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Patients with Primary Insomnia.
MedDRA version: 9.1
Level: LLT
Classification code 10036701
|
|
Intervention(s)
|
Product Code: MK-4305
Pharmaceutical Form: Tablet
Current Sponsor code: MK-4305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: MK-4305
Pharmaceutical Form: Tablet
Current Sponsor code: MK-4305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: MK-4305
Pharmaceutical Form: Tablet
Current Sponsor code: MK-4305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: MK-4305
Pharmaceutical Form: Tablet
Current Sponsor code: MK-4305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
|
Main Objective: To evaluate the efficacy of MK-4305 high dose compared with placebo in improving insomnia: 1.as measured by change from baseline in mean subjective total sleep time (sTSTm) on the daily sleep e-diary at Month 1. 2.as measured by the change from baseline in wakefulness after persistent sleep onset (WASO) at Month1. 3.as measured by change from baseline in mean subjective total sleep time (sTSTm) on the daily sleep e-diary at Month 3. 4.as measured by the change from baseline in wakefulness after persistent sleep onset (WASO) at Month3. 5.as measured by change from baseline in mean subjective time to sleep onset (sTSOm) on the daily sleep e-diary at Month 1. 6.as measured by the change from baseline in latency to onset of persistent sleep (LPS) at Month 1. 7.as measured by change from baseline in mean subjective time to sleep onset (sTSOm) on the daily sleep e-diary at Month 3. 8. as measured by the change from baseline in latency to onset of persistent sleep (LPS) at Month 3.
|
|
Primary end point(s): The primary efficacy endpoints in this study will be derived from polysomnographic measures and from responses in the patient`s daily e-diary. PSG values for statistical analysis will be based on standardized readings from a PSG reading center. Subjective data for statistical analysis will be based on patient responses to the morning and evening questionnaires provided in the e-diary. The following parameters will be evaluated as the primary endpoints: • Maintenance: o Change from baseline in mean subjective total sleep time (sTSTm) on the daily e-diary at Month 1 and Month 3 o Change from baseline in wakefulness after persistent sleep onset (WASO) by PSG at Month 1 and Month 3 • Onset: o Change from baseline in mean subjective time to sleep onset (sTSOm) by daily e-diary at Month 1 and Month 3 o Change from baseline in latency to onset of persistent sleep (LPS) by PSG at Month 1 and Month 3 Safety endpoints: • Adverse Experience Reporting • Laboratory evaluations (hematology, chemistry, urinalysis) • Urine drug screen • Pregnancy test • Alcohol breath test (PQ-cohort only) • Physical examination • Electrocardiogram (ECG) • Vital signs • Tyrer Withdrawal Symptom Questionnaire via the evening e-diary questionnaire • Digit Symbol Substitution Test (PQ-cohort only) • Columbia Suicide Severity Rating Scale • Motor Vehicle Accidents and Violations
|
|
Secondary Objective: Maintainence 1.to evaluate the efficacy of MK-4305 high dose compared with placebo in improving insomnia, as measured by change from baseline in mean subjective total sleep time (sTSTm) on the daily sleep e-diary at Week 1. 2.To evaluate the efficacy of MK-4305 high dose compared with placebo in improving insomnia, as measured by the change from baseline in wakefulness after persistent sleep onset (WASO) at Night 1. Onset 3.To evaluate the efficacy of MK-4305 high dose compared with placebo in improving insomnia, as measured by change from baseline in mean subjective time to sleep onset (sTSOm) on the daily sleep e-diary at Week 1. 4.To evaluate the efficacy of MK-4305 high dose compared with placebo in improving insomnia, as measured by the change from baseline in latency to onset of persistent sleep (LPS) at Night 1.
|
|
Secondary ID(s)
|
|
MK4305-029-00
|
|
2010-018414-69-ES
|
|
Source(s) of Monetary Support
|
|
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|