Trigeminal NeuralgiaPhase 1NCT02359344
PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers
A Phase 1 study testing CNV1014802 in people with Trigeminal Neuralgia, run by Biogen at 1 site in United Kingdom.
Trial summary
A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in healthy young versus elderly male and female subjects. Treatment periods will be separated by 13 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- CNV1014802
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Feb 2015to 20 Apr 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female over 18 years using acceptable methods of contraception
Who cannot join
- Positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
- History or evidence of alcohol or drug abuse
- Pregnant or lactating females
- Participation in a clinical trial within 3 months or the current study or exposure to more than four new chemical entities within 12 months.
- Use of prohibited concomitant medication
- History or presence of any clinically significant abnormality in vital signs / ECG / laboratory tests, or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety.
- Relevant history of a suicide attempt or suicidal behavior
- Note: Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Two Period Crossover Study to Investigate the Pharmacokinetics, Tolerability and Cognitive Effects of an Oral Dose Regimen of 150mg Tid CNV1014802 in Healthy Young Versus Elderly Male and Female Subjects
A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in healthy young versus elderly male and female subjects. Treatment periods will be separated by 13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.
Read the detailed description
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
- Conditions
- Trigeminal Neuralgia
- Being tested
- CNV1014802, Placebo
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNV1014802Drug
Also called BIIB074
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CNV1014802 | Experimental | CNV1014802 150mg three times a day (tid) 7 days plus a single dose on day 8 Receives: Drug: CNV1014802 |
| Placebo | Placebo comparator | Placebo tid 7 days plus a single dose on day 8 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration
Measured: 9 days
Area under the concentration curve
Measured: 9 days
Minimum concentration
Measured: 9 days
Frequency of adverse events
Measured: 9 days
Change in vital signs compared to baseline
Measured: 9 days
Change in 12-lead ECG parameters compared to baseline
Measured: 9 days
Change in safety lab parameters compared to baseline
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start3 Feb 2015
- Primary completion20 Apr 2015
- Study completion20 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359344
- Sponsor's protocol ID
- 1014802/101
- Other IDs
- 2014-004980-19, 2014
- Status last verified
- Oct 2017
- First submitted
- 2 Feb 2015
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Two Period Crossover Study to Investigate the Pharmacokinetics, Tolerability and Cognitive Effects of an Oral Dose Regimen of 150mg Tid CNV1014802 in Healthy Young Versus Elderly Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02359344
- Acronym / sponsor ID
- 1014802/101
- Conditions
- Trigeminal Neuralgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2015 (actual)
- Primary completion
- 20 Apr 2015 (actual)
- Study completion
- 20 Apr 2015 (actual)
- First posted
- 10 Feb 2015 (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.
A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in healthy young versus elderly male and female subjects. Treatment periods will be separated by 13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.
Detailed description
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNV1014802 | Experimental | Drug: CNV1014802CNV1014802 150mg three times a day (tid) 7 days plus a single dose on day 8 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tid 7 days plus a single dose on day 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and female over 18 years using acceptable methods of contraception
Key exclusion criteria (8 listed)
- Positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
- History or evidence of alcohol or drug abuse
- Pregnant or lactating females
- Participation in a clinical trial within 3 months or the current study or exposure to more than four new chemical entities within 12 months.
- Use of prohibited concomitant medication
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 |
|---|---|---|
| CNV1014802Also: BIIB074 | Drug | CNV1014802 |
| Placebo | Drug | Placebo |
Primary outcome
Maximum Concentration
Time frame: 9 days
Area under the concentration curve
Time frame: 9 days
Minimum concentration
Time frame: 9 days
Frequency of adverse events
Time frame: 9 days
Change in vital signs compared to baseline
Time frame: 9 days
Change in 12-lead ECG parameters compared to baseline
Time frame: 9 days
Change in safety lab parameters compared to baseline
Time frame: 9 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 12 Oct 2017.
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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.
Medical Director study director
Biogen
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 CNV1014802 in people with Trigeminal Neuralgia, run by Biogen at 1 site in United Kingdom.
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 1 inclusion and 8 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 12 Oct 2017. 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 United Kingdom. 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?
Maximum Concentration (time frame: 9 days). The study lists 7 primary outcomes in all. 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 12 Oct 2017.