FibromyalgiaPhase 1NCT04974359
A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia
A Phase 1 study testing Lu AG06466 in people with Fibromyalgia, run by H. Lundbeck A/S at 1 site in United States.
Trial summary
The purpose of this study is to find out the effect of Lu AG06466 on the body in participants with fibromyalgia by assessing pain levels, brain signal changes, and psychiatric (mental) assessments. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Lu AG06466
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to 26 Jan 2022
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant has a body mass index (BMI) of ≥18.5 and ≤38.0 kilograms (kg)/square meter (m^2).
- The participant has a fibromyalgia diagnosis, with self-reported pain visual analogue scale (VAS) score >4, based on a self-reported pain diary assessed for a minimum of 4 out of 7 days prior to the Baseline Visit.
- The participant is, in the opinion of the investigator, eligible based on medical history, a physical examination, a neurological examination, vital signs (including orthostatic vital signs), an electrocardiogram (ECG), and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.
Who cannot join
- The participant has a disease, including clinically significant liver disease of any origin, or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
- The participant has any other disorder for which the treatment takes priority over the treatment of fibromyalgia in this study or is likely to interfere with the study treatment or impair treatment compliance.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative NeuroScience Network LLC
Long Beach, California, 90806
About this study
Official title: Interventional, Randomized, Double-Blind, Crossover, Placebo-Controlled, Multiple-Dose Lu AG06466 Phase IB Study in Patients With Fibromyalgia Using Neuroimaging to Investigate Its Pharmacodynamic Effects on Central Pain Processing and Neuroinflammation
The purpose of this study is to find out the effect of Lu AG06466 on the body in participants with fibromyalgia by assessing pain levels, brain signal changes, and psychiatric (mental) assessments.
Read the detailed description
This study will include 2 treatment periods and will utilize a crossover study design with a 7- to 14-day washout period between each 22-day treatment period.
- Conditions
- Fibromyalgia
- Being tested
- Lu AG06466, Placebo
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG06466Drug
Lu AG06466 - capsules
PlaceboDrug
Placebo - capsules
| Study group | Role | What they receive |
|---|---|---|
| Lu AG06466 | Experimental | Participants will receive an oral titrated dose of Lu AG06466 once daily for 22 days in 1 of 2 treatment periods. Receives: Drug: Lu AG06466 |
| Placebo | Placebo comparator | Participants will receive an oral dose of placebo matching to Lu AG06466 once daily for 22 days in 1 of 2 treatment periods. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain Test
BOLD response was evaluated using Functional Magnetic Resonance Imaging (fMRI). During the evoked-pain test, each participant will undergo a block design scan, during which 3 cuff pressures ('light touch' = 30 millimeter of mercury [mmHg]; 'equal pressure' = 120 mmHg; 'equal pain' = 40 to 60/100 Numeric Rating Scale [NRS] units) will be applied to the left calf using the pressure cuff device in pseudo random order.
Measured: Day 22 of each 22-day treatment period
Change in Resting State fMRI (rsfMRI) Functional Connectivity, Assessed by Voxelwise Connectivity Maps Based in Seed Voxels
Each participant will undergo a task-free resting state scan, where in they will be instructed to focus on a static fixation cross.
Measured: Day 22 of each 22-day treatment period
fMRI Data: BOLD Percent Signal Change Under Conditions of Visual Stimulation Versus Fixation
Each participant will undergo a block design scan, with alternating blocks of flashing checkerboard and a static fixation cross.
Measured: Day 22 of each 22-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start24 Jun 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Why it stopped: Study terminated due to enrolment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974359
- Sponsor's protocol ID
- 19365A
- Status last verified
- Jan 2022
- First submitted
- 28 Jun 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-Blind, Crossover, Placebo-Controlled, Multiple-Dose Lu AG06466 Phase IB Study in Patients With Fibromyalgia Using Neuroimaging to Investigate Its Pharmacodynamic Effects on Central Pain Processing and Neuroinflammation
- ClinicalTrials.gov ID
- NCT04974359
- Acronym / sponsor ID
- 19365A
- Conditions
- Fibromyalgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to enrolment challenges.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 23 Jul 2021 (actual)
- 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 purpose of this study is to find out the effect of Lu AG06466 on the body in participants with fibromyalgia by assessing pain levels, brain signal changes, and psychiatric (mental) assessments.
Detailed description
This study will include 2 treatment periods and will utilize a crossover study design with a 7- to 14-day washout period between each 22-day treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lu AG06466 | Experimental | Drug: Lu AG06466Participants will receive an oral titrated dose of Lu AG06466 once daily for 22 days in 1 of 2 treatment periods. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive an oral dose of placebo matching to Lu AG06466 once daily for 22 days in 1 of 2 treatment periods. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The participant has a body mass index (BMI) of ≥18.5 and ≤38.0 kilograms (kg)/square meter (m^2).
- The participant has a fibromyalgia diagnosis, with self-reported pain visual analogue scale (VAS) score >4, based on a self-reported pain diary assessed for a minimum of 4 out of 7 days prior to the Baseline Visit.
- The participant is, in the opinion of the investigator, eligible based on medical history, a physical examination, a neurological examination, vital signs (including orthostatic vital signs), an electrocardiogram (ECG), and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.
Key exclusion criteria (3 listed)
- The participant has a disease, including clinically significant liver disease of any origin, or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
- The participant has any other disorder for which the treatment takes priority over the treatment of fibromyalgia in this study or is likely to interfere with the study treatment or impair treatment compliance.
- Other inclusion and exclusion criteria may apply.
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 |
|---|---|---|
| Lu AG06466Lu AG06466 - capsules | Drug | Lu AG06466 |
| PlaceboPlacebo - capsules | Drug | Placebo |
Primary outcome
Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain Test
Time frame: Day 22 of each 22-day treatment period
BOLD response was evaluated using Functional Magnetic Resonance Imaging (fMRI). During the evoked-pain test, each participant will undergo a block design scan, during which 3 cuff pressures ('light touch' = 30 millimeter of mercury [mmHg]; 'equal pressure' = 120 mmHg; 'equal pain' = 40 to 60/100 Numeric Rating Scale [NRS] units) will be applied to the left calf using the pressure cuff device in pseudo random order.
Change in Resting State fMRI (rsfMRI) Functional Connectivity, Assessed by Voxelwise Connectivity Maps Based in Seed Voxels
Time frame: Day 22 of each 22-day treatment period
Each participant will undergo a task-free resting state scan, where in they will be instructed to focus on a static fixation cross.
fMRI Data: BOLD Percent Signal Change Under Conditions of Visual Stimulation Versus Fixation
Time frame: Day 22 of each 22-day treatment period
Each participant will undergo a block design scan, with alternating blocks of flashing checkerboard and a static fixation cross.
Results and safety
The study was stopped early (reason given: Study terminated due to enrolment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
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 Lu AG06466 in people with Fibromyalgia, run by H. Lundbeck A/S at 1 site in United States.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 11 Feb 2022. 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 States. 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 was stopped early (reason given: Study terminated due to enrolment challenges.). Results are not available in the source record.
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?
Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain Test (time frame: Day 22 of each 22-day treatment period). The study lists 3 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 11 Feb 2022.