- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01114126
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia
Randomized, Double-blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Rouffach, France, 68250
- Centre hospitallier de Rouffach
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary insomnia male or female subjects according to DSM-IV criteria (307.42) ,
- Sleep latency of > 30 minutes and total sleep time < 6 hrs based on Sleep History Questionnaire (SHQ) and verified by the inclusion + habituation night PSG,
- Men or women 18 to 65 years inclusive,
Women of childbearing potential must have a negative pregnancy test at the screening visit, on Day 1 of each treatment period, and use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake. Reliable methods of contraception are:
- Double barrier type devices (e.g., male or female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
- Intra-uterine devices in combination with a spermicide. Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
- Subjects must be in good health as determined by their medical history, physical examination, ECG, vital signs, standard EEG, serum biochemistry, haematology and urinalysis. A subject with clinical abnormality may be included only if the investigator or his designee considers that the abnormality will not introduce additional risk factor for the subject's health, or interfere with the study objectives,
- Subjects who have not been using BZD and non-BZD hypnotics or melatoninergic drugs for the past 2 weeks or more prior to Screening,
- Subjects who have not been using psychotropic treatments for the past 3 months or more prior to screening,
- Subjects who have not been using any other non-psychotropic treatments for the past 2 weeks or more prior to Screening with the exception of occasional paracetamol intake (1 g per day),
- Subjects having read and signed the informed consent form,
- Subjects having a body mass index between 18 and 30 (extremes included),
- Subjects having no documented hypersensitivity to exogenous melatonin or agonists,
- Subjects who agree to completely refrain from alcohol, caffeine and tobacco during the institutionalisation periods,
- Subjects able to take part in the whole study,
- Subjects affiliated with, or beneficiary of, a social security system
Exclusion Criteria:
- According to DSM IV, subjects belonging to the following groups are excluded: 780.59 (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47 (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical condition) ,
- Subjects suffering from insomnia secondary to other causes according to SHQ,
- Subjects with sleep disorders detected during the PSG inclusion/habituation night, such as sleep apnea/hypopnea and periodic leg movement syndrome (with arousal) (PLMI > 15 and/or AHI > 15 per hour),
- Subjects with known chronic infections or asthma, allergies or history of severe allergy,
- Subjects with hypertension defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg according to two repeated measures in lying position within 10 min interval,
- Subjects with hypotension defined as systolic blood pressure <90 mmHg and/or diastolic blood pressure < 45 mmHg according to two repeated measures in lying position within 10 min interval,
- Subjects with foreseeable need of a treatment, whatever it is (including dental care), during the study period,
- Subjects with positive drug screening for amphetamines, benzodiazepines, barbiturates, cannabis, cocaine morphine/opiates, methadone, tricyclics, methamphetamines (ecstasy) and codeine, or suspected to be drug or alcohol addicted,
- Subjects with positive serology to human immunodeficiency virus antibodies (HIV Ab),
- Subjects positive for Hepatitis B virus surface antigen (HBs Ag) or hepatitis C virus antibodies (HCV Ab),
- Subjects with previous or on-going chronic or recurrent disease especially convulsive disorders or central nervous system or psychiatric disease,
- Subjects with history of pathology likely to recur during or immediately after the study,
- Subjects with significant cardio-vascular, pulmonary, renal, hepatic, gastro-intestinal, neurological, psychiatric, endocrine, cancer or blood disease,
- Subjects having taken any unstable treatment with central effects within 90 days prior to experiment,
- Subjects with an alcohol consumption more than 40 g of alcohol per day,
- Subjects drinking more than 6 cups of coffee (or equivalent in xanthine-containing beverages) per day,
- Subjects smoking more than 5 cigarettes per day,
- Subjects with known drug addiction,
- Subjects having donated more than 300 ml of blood within 90 days prior to the start of the study,
- Subjects being in the exclusion period according to the French National File for Volunteers Participating in a Biomedical Research,
- Subjects having earned a total annual amount of compensation from participating in clinical studies exceeding 4500 Euros (including compensation for this study),
- Subjects with legal incapacity or limited legal capacity,
- Subjects likely, according to investigator's opinion, not to cooperate with or to respect the constraints of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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comparison of different dosages
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Experimental: Neu-P11 2mg
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comparison of different dosages of drug
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Experimental: Neu-P11 5 mg
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comparison of different dosages of drug
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Experimental: Neu-p11 20 mg
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comparison of different dosages of drug
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Experimental: Neu-P11 50 mg
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comparison of different dosages of drug
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and description of participants with adverse events
Time Frame: 5 days
|
adverse events will be recorded and reported throughout the study
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5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neu-P11 concentration, exposure and clearance
Time Frame: 5 days
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To learn about the concentration, exposure and clearence of to Neu-P11 Pharmacokinetic(PK)parameters will be recorded and reported:
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5 days
|
Objective and subjective assessment sleep quality
Time Frame: 5 days
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PSG parameters (sleep time, efficiency and architecture) as an objective assessment of sleep quality will be recorded Subjective means of evaluation of sleep qulity will include:
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5 days
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Subjective evaluation of mood and emotions
Time Frame: 5 days
|
To study the effect of Neu-P11 on mood and emotions, subjective evaluation of mood and emotions will be recorded and reported using:
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5 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neu-P11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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