|
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:
|
30 June 2019 |
|
Main ID: |
EUCTR2008-006018-97-GB |
|
Date of registration:
|
28/04/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia.
|
|
Scientific title:
|
A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia.
|
|
Date of first enrolment:
|
28/01/2009 |
|
Target sample size:
|
250 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006018-97 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Prestudy Inclusion (Visit 1):
Patient is male or female between 18 and < 65 years of age.
Patient has a DSM-IV-TR 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.
Patient reports a total sleep time of = 6.5 hours on at least 3 out of 7 nights each week within the 4 weeks prior to Visit 1, when not medicated on a hypnotic agent.
Patient reports a sleep latency of = 30 minutes on at least 3 out of 7 nights each week within the 4 weeks prior to Visit 1, when not medicated on a hypnotic agent.
Patient has = 1 hour of wakefulness after sleep onset.
Patient spends 6.5 to 9 hours nightly in bed.
Patient is willing to stay in bed for at least 8 hours each night while at the sleep laboratory.
The patient’s regular bedtime is between 9 PM (21:00) and 12 AM (00:00).
Screening PSG Inclusion (Visit 2):
Patient has LPS > 20 minutes during the Screening PSG at Visit 2. NOTE: “Persistent sleep” is defined as the first continuous 20 epochs (30 seconds each) of a non-wake state.
Patient has WASO > 45 minutes during the Screening PSG at Visit 2.
Baseline PSG Inclusion (Visit 3):
Patient has LPS > 20 minutes on both Screening and Baseline PSG nights.
Patient has a mean WASO = 60 minutes on the combined Screening and Baseline PSG nights, where neither night is = 45 minutes.
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Prestudy Exclusion (Visit 1):
Patient has any history of a neurological disorder, including but not limited to seizure disorder (other than single episodes of childhood febrile seizures), epilepsy, stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, significant head trauma with sustained loss of consciousness, or classical migraine headaches in the last 10 years.
Patient has an active Axis I or II disorder as defined in the DSM-IV-TR and as assessed by the Mini International Neuropsychaitric Interview, other than Primary Insomnia. Patient has a history of Bipolar Disorder, Psychotic Disorder, or any history of antipsychotic use.
Patient has evidence of ongoing depression as determined by a score = 20 on the Quick Inventory of Depressive Symptomatology – Self Report Scale (QIDS-SR16), or scores = 2 on the QIDS-SR16 suicide item #12, or in the judgment of the investigator the patient is impaired, suicidal or otherwise in such a way as to be unable to complete the study procedures in a safe and appropriate fashion (regardless of QIDS-SR16 score).
Patient has a history of substance abuse or dependence (except if currently in sustained full remission for at least one year or meets criteria for early full remission, according to DSM-IV-TR).
Patient has a history of transmeridian travel (across > 3 time zones) or shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks or anticipates needing to travel (across > 3 time zones) at any time during the study.
Patient has a history of any of following conditions:
a. Narcolepsy
b. Cataplexy
c. Circadian rhythm sleep disorder
d. Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and REM behavior disorder
e. Sleep-related breathing disorder
f. Periodic limb movement disorder
g. Restless legs syndrome
Screening PSG Exclusion (Visit 2):
Patient has an underlying pathology of sleep identified during the screening PSG:
a. An Apnea Hypopnea Index >10
b. >10 periodic leg movements associated with an arousal per hour of sleep (PLMAs).
Patient has a positive alcohol breath test as analyzed by a breathalyzer machine.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Primary Insomnia
MedDRA version: 9.1
Level: LLT
Classification code 10036701
Term: Primary insomnia
|
|
Intervention(s)
|
Product Name: MK-4305
Product Code: MK-4305
Pharmaceutical Form: Tablet
Other descriptive name: MK-4305, L-001958419, 5-Chloro-2-{(5R)-5-methyl-4-[5-methyl-2-(2H-1,2,3-triazol-2-
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: MK-4305
Product Code: MK-4305
Pharmaceutical Form: Tablet
Other descriptive name: MK-4305, L-001958419, 5-Chloro-2-{(5R)-5-methyl-4-[5-methyl-2-(2H-1,2,3-triazol-2-
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
|
|
Primary Outcome(s)
|
Secondary Objective: 1. To evaluate the efficacy of MK-4305 compared with placebo in improving wake after sleep onset (WASO) as measured by PSG on Night 1 and the end of 4 weeks of treatment.
2. To evaluate the efficacy of MK-4305 compared with placebo in improving latency to persistent sleep (LPS) as measured by PSG on Night 1 and at the end of 4 weeks of treatment.
|
|
Primary end point(s): Sleep variables of Sleep efficiency (SE), Latency to persistent sleep (LPS), Wake after sleep onset (WASO); as derived by overnight polysomnography (PSG)
|
Main Objective: 1. To evaluate the efficacy of MK-4305 compared with placebo in improving sleep efficiency (SE) as measured by polysomnography (PSG) on Night 1 and at the end of 4 weeks of treatment, where SE is defined as 100 times total sleep time (minutes) divided by time in bed (minutes).
2. To evaluate the safety and tolerability of MK-4305.
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|