Peripheral Nervous System DiseasesPhase 1NCT05229042
A Study to Investigate the Safety and Efficacy of Ricolinostat
A Phase 1 study testing Ricolinostat in people with Peripheral Nervous System Diseases, run by Beijing 3E-Regenacy Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral Nervous System Diseases
- What is being tested?
- Ricolinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 10 Nov 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study's purpose and requirements, and able to voluntarily provide informed consent to participate.
- Age ≥ 18 years and < 70 years at the time of signing the informed consent form (ICF).
- Female patients diagnosed with breast cancer:
- Who have been treated with either docetaxel or paclitaxel.
- Who have a Karnofsky performance status of 70 or more at Screening.
- Who have completed their chemotherapy at least 1 month prior to randomization.
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- Neuropathy of <Grade 4 using the general guideline of grading scales defined in Common Terminology Criteria for Adverse Events (CTCAE; v5.0) .
- Women of childbearing potential (WOCBP) must agree to use reliable contraceptive methods for the duration of the study and for at least 3 months after completing treatment with study drug. For the purposes of this study, reliable methods of contraception include abstinence, oral contraceptives, hormonal contraceptive implants such as Nexplanon, hormonal vaginal ring such as NuvaRing, intrauterine devices in place for at least 3 months, or barrier methods used in conjunction with spermicide. To be considered post-menopausal and of non childbearing potential, women less than 60 years with less than 2 years since their last period must have follicle-stimulating hormone (FSH) > 40 IU/L and estradiol < 20 pg/mL unless on hormone replacement.
- Able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Women who are pregnant or lactating.
- Extremely overweight, defined as body mass index (BMI) > 40 kg/m2.
- Presence of any neuropathy other than CIPN.
- Presence of a clinical condition commonly associated with neuropathy that could better account for the presence of the patient's neuropathy, such as diabetes or a risk factor for marked B12 deficiency (malabsorption syndrome, atrophic gastritis, strict vegan diet, etc.), or a megaloblastic (macrocytic) anemia consistent with B12 deficiency.
- Presence of skin conditions in the affected dermatome that, in the judgement of the Investigator, could interfere with evaluation of the neuropathic pain condition.
- Presence of non-CIPN pain that may interfere with study assessments and/or self-evaluation of peripheral neuropathic pain.
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- History of alcoholism or drug/chemical abuse within 1 year prior to randomization as judged by the Investigator based on clinical history.
- Opioid use at a dose of ≥ 30 morphine milligram equivalents on 3 or more days a week during the month at Screening.
- The use of cannabidiol (CBD) during the 1 month at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study to Investigate the Safety and Efficacy of Ricolinostat for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.
Read the detailed description
This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.
Prior to randomization, patients will participate in the Screening and Baseline assessment period to ensure that they meet study inclusion/exclusion criteria.
Following the Screening and Baseline assessment period, patients who meet entry criteria will be randomized in a 2:1 ratio to receive either ricolinostat or placebo.
- Conditions
- Peripheral Nervous System Diseases
- Being tested
- Ricolinostat
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RicolinostatDrug
Also called Placebo
Oral
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Subjects received ricolinostat Receives: Drug: Ricolinostat |
| Placebo arm | Placebo comparator | Subjects received placebo Receives: Drug: Ricolinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAT
The primary endpoint is the incidence of treatment-emergent adverse events (TEAEs) during the Treatment period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Jan 2022
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nervous System DiseasesStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binhe Xue, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229042
- Sponsor's protocol ID
- BCRG-CN-101
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Investigate the Safety and Efficacy of Ricolinostat for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
- ClinicalTrials.gov ID
- NCT05229042
- Acronym / sponsor ID
- BCRG-CN-101
- Conditions
- Peripheral Nervous System Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 8 Feb 2022 (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.
This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.
Detailed description
This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.
Prior to randomization, patients will participate in the Screening and Baseline assessment period to ensure that they meet study inclusion/exclusion criteria.
Following the Screening and Baseline assessment period, patients who meet entry criteria will be randomized in a 2:1 ratio to receive either ricolinostat or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Drug: RicolinostatSubjects received ricolinostat |
| Placebo arm | Placebo comparator | Drug: RicolinostatSubjects received placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to understand the study's purpose and requirements, and able to voluntarily provide informed consent to participate.
- Age ≥ 18 years and < 70 years at the time of signing the informed consent form (ICF).
- Female patients diagnosed with breast cancer:
- Neuropathy of <Grade 4 using the general guideline of grading scales defined in Common Terminology Criteria for Adverse Events (CTCAE; v5.0) .
- Women of childbearing potential (WOCBP) must agree to use reliable contraceptive methods for the duration of the study and for at least 3 months after completing treatment with study drug. For the purposes of this study, reliable methods of contraception include abstinence, oral contraceptives, hormonal contraceptive implants such as Nexplanon, hormonal vaginal ring such as NuvaRing, intrauterine devices in place for at least 3 months, or barrier methods used in conjunction with spermicide. To be considered post-menopausal and of non childbearing potential, women less than 60 years with less than 2 years since their last period must have follicle-stimulating hormone (FSH) > 40 IU/L and estradiol < 20 pg/mL unless on hormone replacement.
Key exclusion criteria (9 listed)
- Women who are pregnant or lactating.
- Extremely overweight, defined as body mass index (BMI) > 40 kg/m2.
- Presence of any neuropathy other than CIPN.
- Presence of a clinical condition commonly associated with neuropathy that could better account for the presence of the patient's neuropathy, such as diabetes or a risk factor for marked B12 deficiency (malabsorption syndrome, atrophic gastritis, strict vegan diet, etc.), or a megaloblastic (macrocytic) anemia consistent with B12 deficiency.
- Presence of skin conditions in the affected dermatome that, in the judgement of the Investigator, could interfere with evaluation of the neuropathic pain condition.
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 |
|---|---|---|
| RicolinostatAlso: PlaceboOral | Drug | Active arm, Placebo arm |
Primary outcome
TEAT
Time frame: 6 months
The primary endpoint is the incidence of treatment-emergent adverse events (TEAEs) during the Treatment period.
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 4 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Binhe Xue principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Ricolinostat in people with Peripheral Nervous System Diseases, run by Beijing 3E-Regenacy Pharmaceuticals Co., Ltd. at 1 site in China.
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 9 inclusion and 9 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 4 Dec 2023. 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 China. 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?
TEAT (time frame: 6 months). 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 4 Dec 2023.