Postural InstabilityPhase 4NCT01280734
Investigation of Melatonin and Zolpidem Effect on Postural Instability in Healthy Adult Subjects
A Phase 4 study testing Circadin (R) 2 mg and Stilnox (R) 10 mg in people with Postural Instability, run by Neurim Pharmaceuticals Ltd. at 1 site in France.
Trial summary
This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on night time awakening body sway of melatonin and zolpidem in healthy adult subjects aged of 55 to 64 years. Read more about this study
- Who is it for?
- Ages 55 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Instability
- What is being tested?
- Circadin (R) 2 mg and Stilnox (R) 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to May 2011
- Phase
- Phase 4
- 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 55 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must have signed an informed consent form.
- The subject is a healthy man or woman. Women of child bearing potential or within two years of menopause must have negative urine pregnancy test at screening and use contraceptives as indicated in the protocol.
- The subject is 55 to 64 years of age (extremes included).
- The subject has a BMI >19 kg/m2 and < 30 kg/m2 at the Screening Visit.
- The subject has a normal circadian rhythm, defined as a person who usually wakes between 06:00 and 09:00 and goes to sleep between 21:00 and 24:00.
- The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history and examination at screening
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- The subject is affiliated with, or beneficiary of a social security system.
- Major Exclusion Criteria:
- The subject has taken disallowed medication within 1 week prior to the first dose of IMP (or within 5 half-lives prior to admission for any medication ingested, whichever is longer). Disallowed medication is any prescribed medication or over-the-counter (OTC) medication as well as any herbal medicine known to interfere with the metabolic CYP pathways, such as St. John's Wort (except for hormonal contraceptives or hormonal substitution therapy). Subjects who have taken any non-prescribed systemic or topical medication may still be entered into the study if, in the opinion of the investigator, the medication will not interfere with the study procedures, study results, or compromise safety.
- The subject weighs >136 kg.
- The subject cannot stand erect and unsupported for more than 2 to 3 minutes or loses balance when standing on a fixed surface with eyes opened.
- The subject has an excessive consumption of beverages on xanthine bases (more than 4 cups or glasses daily).
- The subject has a presence or history of alcohol abuse defined as alcohol consumption greater than 21 units per week for men and greater than 14 units per week for women; or a presence or history of drug abuse within the last 6 months, or a history of substance abuse deemed relevant by the investigator.
- The subject has taken any investigational products including these IMPs (zolpidem, melatonin) within 3 months prior to admission on Day 1.
- The subject has taken these IMPs earlier in this clinical study.
- The subject has known hypersensitivity to the melatonin, zolpidem or their excipients.
- The subject has a history of severe drug allergy or hypersensitivity.
- The subject is pregnant or breastfeeding.
- The subject has a presence or history of sleep disorder, fainting, cardiovascular diseases, carotid sinus syndrome, relevant dizziness or arrhythmia.
- The subject has a history of or presence of any clinically relevant immunological, cardiovascular, pulmonary, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, systemic, ocular or psychiatric or infectious disease or other major disorder, or sign of acute illness.
- The subject has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, which has not been in remission for at least 5 years before the first dose of IMP.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-blind, 3-way Crossover, Single Dose, Placebo-controlled Study Investigating the Effect on Postural Instability of Melatonin and Zolpidem in Healthy Adult Subjects Aged of 55 to 64 Years.
This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on night time awakening body sway of melatonin and zolpidem in healthy adult subjects aged of 55 to 64 years.
- Conditions
- Postural Instability
- Being tested
- Circadin (R) 2 mg, Stilnox (R) 10 mg, Placebo
- Keywords
- melatonin, circadin, zolpidem, body sway, postural instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadin (R) 2 mgDrug
One 2 mg tablet at 23:00
Stilnox (R) 10 mgDrug
One 10 mg encapsulated tablet at 23:00
PlaceboDrug
One tablet or encapsulated tablet at 23:00
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | Circadin(R) 2 mg tablet 2 hours at 23:00 Receives: Drug: Circadin (R) 2 mg |
| Zolpidem | Active comparator | Stilnox (R) 10 mg tablet at 23:00 Receives: Drug: Stilnox (R) 10 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body sway
Measured: 4 hours post IMP adminstration
Secondary outcomes (1)
Body Sway
Measured: 1.5 hours post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural InstabilityStudies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurim Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280734
- Sponsor's protocol ID
- Neurim-PIS1
- Other IDs
- 2010-023745-29
- Status last verified
- Dec 2011
- First submitted
- 19 Jan 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, 3-way Crossover, Single Dose, Placebo-controlled Study Investigating the Effect on Postural Instability of Melatonin and Zolpidem in Healthy Adult Subjects Aged of 55 to 64 Years.
- ClinicalTrials.gov ID
- NCT01280734
- Acronym / sponsor ID
- Neurim-PIS1
- Conditions
- Postural Instability
- Keywords
- melatonin, circadin, zolpidem, body sway, postural instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Neurim Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Jan 2011 (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.
This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on night time awakening body sway of melatonin and zolpidem in healthy adult subjects aged of 55 to 64 years.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Drug: Circadin (R) 2 mgCircadin(R) 2 mg tablet 2 hours at 23:00 |
| Zolpidem | Active comparator | Drug: Stilnox (R) 10 mgStilnox (R) 10 mg tablet at 23:00 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- The subject must have signed an informed consent form.
- The subject is a healthy man or woman. Women of child bearing potential or within two years of menopause must have negative urine pregnancy test at screening and use contraceptives as indicated in the protocol.
- The subject is 55 to 64 years of age (extremes included).
- The subject has a BMI >19 kg/m2 and < 30 kg/m2 at the Screening Visit.
- The subject has a normal circadian rhythm, defined as a person who usually wakes between 06:00 and 09:00 and goes to sleep between 21:00 and 24:00.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Circadin (R) 2 mgOne 2 mg tablet at 23:00 | Drug | Melatonin |
| Stilnox (R) 10 mgOne 10 mg encapsulated tablet at 23:00 | Drug | Zolpidem |
| PlaceboOne tablet or encapsulated tablet at 23:00 | Drug | Placebo |
Primary outcome
Body sway
Time frame: 4 hours post IMP adminstration
1 secondary outcome
Body Sway
Time frame: 1.5 hours post administration
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 13 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Circadin (R) 2 mg and Stilnox (R) 10 mg in people with Postural Instability, 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 21 inclusion and 0 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 13 Dec 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Body sway (time frame: 4 hours post IMP adminstration). 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 13 Dec 2011.