InsomniaPhase 1NCT01114126
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia
A Phase 1 study testing Neu-P11 in people with Insomnia, run by Neurim Pharmaceuticals Ltd. at 1 site in France.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of Neu-P11, following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching placebo) given nightly over 2 periods of 5 days to male and female subjects with primary insomnia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Neu-P11
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia
The primary objective of the study is to evaluate the safety and tolerability of Neu-P11, following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching placebo) given nightly over 2 periods of 5 days to male and female subjects with primary insomnia. In addition, the study is aimed to determine the pharmacokinetic profile of Neu-P11 after 1 and 5 days of administration and to evaluate the hypnotic effects of Neu-P11 as well as the effects on mood and memory. The study hypothesis is that Neu-P11 is safe, tolerated and have significant sleep promoting effects.
Read the detailed description
The effects of four multiple ascending doses of orally administered Neu-P11 will be evaluated in a double- blind, placebo-controlled, crossover design. Following a screening visit, the recruited subjects will undergo an inclusion/habituation full night PSG screening recording in the sleep clinic to exclude subjects with sleep disorders. Eligible subjects will be divided into 2 cohorts of 12 subjects each. Following screening, each cohort will be randomised to receive Neu-P11 or placebo for a first period of 5 days and will be crossed over following at least 21 days to receive placebo or a higher dose of Neu-P11 for a second period of 5 days. Each cohort will receive a different dose of Neu-P11, chosen from 2, 5, 20 and 50 mg. The starting dose is 5 mg but a smaller dose (2 mg) is also included for the purpose of pharmacodynamic evaluation. Before proceeding from 5mg to the next higher dose safety will be evaluated based on adverse events, clinical and biological data. Subjects of Cohort A will be randomised to dose levels 2 and 3 (doses 5 and 20 mg). Subjects of Cohort B will be randomised to dose levels 1 and 4 (doses 2 and 50 mg).
- Conditions
- Insomnia
- Being tested
- Neu-P11, Neu-P11 placebo
- Keywords
- Neu-P11, Insomnia, PSG, safety
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neu-P11Drug
comparison of different dosages of drug
Neu-P11 placeboDrug
comparison of different dosages
| Study group | Role | What they receive |
|---|---|---|
| Neu-P11 2mg | Experimental | Not described Receives: Drug: Neu-P11 |
| Neu-P11 5 mg | Experimental | Not described Receives: Drug: Neu-P11 |
| Neu-p11 20 mg | Experimental | Not described Receives: Drug: Neu-P11 |
| Neu-P11 50 mg | Experimental | Not described Receives: Drug: Neu-P11 |
| Placebo | Placebo comparator | Not described Receives: Drug: Neu-P11 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and description of participants with adverse events
adverse events will be recorded and reported throughout the study
Measured: 5 days
Secondary outcomes (3)
Neu-P11 concentration, exposure and clearance
To learn about the concentration, exposure and clearence of to Neu-P11 Pharmacokinetic(PK)parameters will be recorded and reported:
- Blood samples for Neu-P11 and metabolites plasma concentration determination will be drawn on several time points at the beginning and at the end of each period
- Urine samples for Neu-P11 and metabolites determination will be collected on several time points at the beginning and at the end of each period.
Measured: 5 days
Objective and subjective assessment sleep quality
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:
- Sleep Diary (NSFSD).
- sleepiness scale (KSS)
Measured: 5 days
Subjective evaluation of mood and emotions
To study the effect of Neu-P11 on mood and emotions, subjective evaluation of mood and emotions will be recorded and reported using:
- Profile of Mood States (POMS).
- Emotional-visual analogue scale (e-VAS).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurim Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Deborah Metzger, MD, Principal investigator, Forenap Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114126
- Sponsor's protocol ID
- Neu-P11
- Status last verified
- Apr 2011
- First submitted
- 15 Apr 2010
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia
- ClinicalTrials.gov ID
- NCT01114126
- Acronym / sponsor ID
- Neu-P11
- Conditions
- Insomnia
- Keywords
- Neu-P11, Insomnia, PSG, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Neurim Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety and tolerability of Neu-P11, following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching placebo) given nightly over 2 periods of 5 days to male and female subjects with primary insomnia. In addition, the study is aimed to determine the pharmacokinetic profile of Neu-P11 after 1 and 5 days of administration and to evaluate the hypnotic effects of Neu-P11 as well as the effects on mood and memory. The study hypothesis is that Neu-P11 is safe, tolerated and have significant sleep promoting effects.
Detailed description
The effects of four multiple ascending doses of orally administered Neu-P11 will be evaluated in a double- blind, placebo-controlled, crossover design. Following a screening visit, the recruited subjects will undergo an inclusion/habituation full night PSG screening recording in the sleep clinic to exclude subjects with sleep disorders. Eligible subjects will be divided into 2 cohorts of 12 subjects each. Following screening, each cohort will be randomised to receive Neu-P11 or placebo for a first period of 5 days and will be crossed over following at least 21 days to receive placebo or a higher dose of Neu-P11 for a second period of 5 days. Each cohort will receive a different dose of Neu-P11, chosen from 2, 5, 20 and 50 mg. The starting dose is 5 mg but a smaller dose (2 mg) is also included for the purpose of pharmacodynamic evaluation. Before proceeding from 5mg to the next higher dose safety will be evaluated based on adverse events, clinical and biological data. Subjects of Cohort A will be randomised to dose levels 2 and 3 (doses 5 and 20 mg). Subjects of Cohort B will be randomised to dose levels 1 and 4 (doses 2 and 50 mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Neu-P11 2mg | Experimental | Drug: Neu-P11 |
| Neu-P11 5 mg | Experimental | Drug: Neu-P11 |
| Neu-p11 20 mg | Experimental | Drug: Neu-P11 |
| Neu-P11 50 mg | Experimental | Drug: Neu-P11 |
| Placebo | Placebo comparator | Drug: Neu-P11 placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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,
Key exclusion criteria (23 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neu-P11comparison of different dosages of drug | Drug | Neu-P11 2mg, Neu-P11 5 mg, Neu-P11 50 mg, Neu-p11 20 mg |
| Neu-P11 placebocomparison of different dosages | Drug | Placebo |
Primary outcome
Number and description of participants with adverse events
Time frame: 5 days
adverse events will be recorded and reported throughout the study
3 secondary outcomes
Neu-P11 concentration, exposure and clearance
Time frame: 5 days
Objective and subjective assessment sleep quality
Time frame: 5 days
Subjective evaluation of mood and emotions
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Metzger, MD principal investigator
Forenap Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neu-P11 in people with Insomnia, run by Neurim Pharmaceuticals Ltd. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and description of participants with adverse events (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.