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Register:	EUCTR
Last refreshed on:	25 September 2012
Main ID:	EUCTR2010-018414-69-FI
Date of registration:	30/03/2010
Prospective Registration:	Yes
Primary sponsor:	MDS Finland Oy
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 -
Date of first enrolment:	08/06/2010
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:
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Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Patient is/reports:
1. Age >18 yrs on the day of signing informed consent.
2. Diagnosed with primary insomnia.
3. In good physical and mental health.
4. If > 65 yrs old, scores > 25 on the Mini Mental State Exam.
5. A female who is of reproductive potential, has a negative serum pregnancy test, and agrees to use contraception.
6. Difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria).
7. Spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1.
8. Regular bedtime between 9pm-1am.
9. Willing to refrain from napping while in study.
10. Able to read, understand and complete questionnaires and all diaries.
11. Willing to limit alcohol, caffeine, and nicotine consumption.

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:
Patient is/reports:
1. A female who is pregnant and breastfeeding at Prestudy visit, or expecting to conceive while in study.
2. A history or diagnosis of sleeping disorders.
3. Difficulty sleeping due to a medical condition.
4. A history of neurological disorders.
5. A history of any clinically severe psychological disorder or current psychiatric disorder that requires a prohibited medication.
6. Ongoing depression.
7. A history of substance abuse or dependence.
8. A history or current evidence of a clinically significant cardiovascular disorder or clinically significant ECG at Prestudy Visit.
9. Taking certain prohibited medications.
10. Consuming the equivalent of >15 cigarettes a day.
11. A history of malignancy < 5 years prior to signing informed consent, with the exception of basal cell or squamous cell skin cancer.
12. Morbidly obese.
13. Was previously randomized in another investigational study of MK-4305.
14. Currently participating or has participated in a clinical study within 30 days of signing informed consent.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Primary Insomnia

Intervention(s)

Product Name: MK-4305
Product Code: MK-4305
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: MK-4305
Product Code: MK-4305
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: MK-4305
Product Code: MK-4305
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: MK-4305
Product Code: MK-4305
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: All Main/Primary objectives are MK-4305 high dose compared to placebo, as measured by change from baseline:
Maintenance-
1. Mean subjective total sleep time (sTSTm) at Month 1.
2. Wakefulness after persistent sleep onset (WASO) by PSG at Month 1.
3. Mean subjective total sleep time (sTSTm) at Month 3.
4. Wakefulness after persistent sleep onset (WASO) by PSG at Month 3.
Onset
5. Mean subjective time to sleep onset (sTSOm) at Month 1.
6. Latency to onset of persistent sleep (LPS) by PSG at Month 1.
7. Mean subjective time to sleep onset (sTSOm) at Month 3.
8. Latency to onset of persistent sleep (LPS) by PSG at Month 3.
Safety
9. Safety and tolerability of MK-4305 for up to 3 months of treatment.

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: All Secondary objectives are MK-4305 high dose compared to placebo, as measured by change from baseline:
Maintainence
1. sTSTm at Week 1
2. WASO at Night 1
Onset
3. sTSOm at Week 1

Secondary Outcome(s)

Secondary ID(s)

2010-018414-69-ES

4305-029

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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