E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036701 |
E.1.2 | Term | Primary insomnia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and tolerability of of MK-4305 for up to 12 months of treatment |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the efficacy of MK-4305 compared with placebo in improving insomnia, as measured by change from baseline in subjective total sleep time (sTST) on the sleep diary during the first month of treatment (using the average of weekly measurements [Weeks 1, 2, 3 and 4]). 2. To evaluate the efficacy of MK-4305 compared with placebo in improving insomnia, as measured by change from baseline in subjective time to sleep onset (sTSO) on the sleep diary during the first month of treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 4. Patient is able to read, understand and complete questionnaires and diaries, including operation of the eDiary. Of note, in the event that eDiaries are not available for a country, paper measures may be used at the SPONSOR’s discretion. 5. Patient has completed at least 6 years of formal education; patient obtains a score ≥ 6th grade level on Reading Subtest of Wide Range Achievement Test Version 4 (WRAT-4) at screening. For languages other than English, the SPONSOR will specify other tests or methods of assessing. 6. For a patient ≥65 years of age, (s)he scores ≥25 on the Mini Mental State Examination (MMSE), to rule out cognitive impairment in the interest of safety for the patient. NOTE: If <65 years old, answer "YES" except in cases where administration of the MMSE to the patient <65 seems indicated in the opinion of the investigator. 7. A female patient who is of reproductive potential has a serum β-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 non-hormonal forms of contraception including: partner using condom with spermicide or status post vasectomy, and patient using 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. 8. 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.
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E.4 | Principal exclusion criteria |
1. If female, patient is pregnant (positive serum pregnancy test at prestudy), breastfeeding, or expecting to conceive within the projected duration of the study. NOTE: If male, answer “NO”. 2. Patient is expecting to donate egg or sperm during the study. 3. Patient has a history of hypersensitivity or idiosyncratic reaction to more than two (2) chemical classes of drugs, including prescriptions and over-the-counter medications. 4. Patient, in the opinion of the investigator, has a history or current evidence of any condition, therapy, lab or ECG abnormality or other circumstances that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate. Examples of excluded disorders include, but are not limited to: HIV or other relevant infections, history of acute or chronic hepatitis, history of gastric bypass or gastric banding surgery, uncontrolled hypertension, or active endocrine disorders (however, patients with well-controlled insulin-dependent diabetes, type II diabetes, or hypothyroidism are allowed if on stable doses of appropriate therapy for ≥1 month prior to Screening Visit 2). 5. Patient has a recent and/or active history of a confounding 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 and residual impairment within the last 10 years.
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E.5 End points |
E.5.1 | Primary end point(s) |
adverse experiences (AEs), laboratory values, ECGs, physical examinations, vital signs, rebound insomnia and withdrawal effects. The Columbia - Classification Algorithm of Suicide Assessment (C-CASA) scores from the C-SSRS will also be evaluated
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 14 |