Chemotherapy-Induced Peripheral NeuropathyPhase 2CIPNNCT00876538
Effect of TRO19622 in the Treatment of Patients With Chemotherapy Induced Peripheral Neuropathy
A Phase 2 study testing Olesoxime (TRO19622) in people with Chemotherapy-Induced Peripheral Neuropathy, run by Hoffmann-La Roche at 8 sites in France.
Trial summary
The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- Olesoxime (TRO19622)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 8 sitesFrance
- Study dates
- Mar 2009to Sep 2010
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed an Informed Consent to participate to the trial before any study related procedure has taken place.
- Be >18 years and if a female with adequate contraception if of child bearing potential.
- Have paclitaxel (or other taxane) induced peripheral neuropathy assessed by the presence of a NCI-CTC version 2 neuropathy sensory grade >/= 2 .
- Peripheral neuropathy as clinically diagnosed during the neurological examination including sensitivity, motor function and deep tendon reflex assessments
- With Neuropathic pain as assessed by the presence of measurable pain perception (previous 24h)on the Likert numerical rating scale >/= 4 points at the screening visit and confirmed on DN4 with a score >/= 4 and/or Dysesthesia as assessed by the presence of measurable dysesthesia (previous 24h) on the Likert numerical rating scale >/= 4 points at the screening visit
- Persistent neuropathy for at least 3, but no more than 12 months after the end of chemotherapy.
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- Be either pain treatment naive or have important side effects or inadequate relief from their current pain medication (stable over last month).
- The following inclusion criteria should be ascertained at the baseline visit:
- Peripheral neuropathy symptoms: Have measurable pain perception (previous 24h) on the Likert numerical rating scale with a mean >/= 4 points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit and/or Dysesthesia as assessed by the presence of measurable dysesthesia with a mean >/= 4 points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit.
- Have an electrocardiogram (ECG) at Baseline without any clinically significant abnormality.
- Have an expected survival > 6 months.
Who cannot join
- Have a documented neuropathy or risk factors of neuropathy which might interfere with the assessment of the severity of pain (eg, including, but not limited to, type 2 diabetes, peripheral vascular disease, B12 Vitamin deficiency, thyroid dysfunction, post surgical neuropathic pain, post-traumatic neuropathy, or neuropathy in relation with disease progression).
- Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality.
- Refractory to treatment defined as not improved, according to the Investigator, by 3 or more treatments prescribed for the current PN symptoms.
- HIV positive serology.
- History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease,including myocardial infarction, except patients with only well controlled hypertension.
- Have had prior (within the past 6 months) or have concurrent neurotoxic drugs (e.g., but not limited to, cisplatin, vincristine, vinblastine, cytarabine, thalidomide, bortezomib, or procarbazine, capecitabine, navelbine).
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- Have a current medication that may have a similar mechanism of action as TRO19622: acetyl-L-carnitine
- Have a current medication that could interfere with TRO19622 pharmacokinetics: tamoxifen
- Have current medications that could interfere with TRO19622 absorption such as ezetimibe, bile salts chelators, fibrates, phytosterols, fish oils.
- Have a current medication of lipid lowering agents other than statins.
- Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
- Have concurrent unstable disease involving any system (eg, advanced carcinoma other than carcinoma justifying the recent treatment with taxanes, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency, anginal symptoms, current symptoms of CAD, renal impairment, or any other condition that in the opinion of the Investigator would make the patient unsuitable for study participation)
- Be pregnant female or lactating.
- Have renal impairment defined as blood creatinine > 1.5× upper limit of normal (ULN)
- Hemostasis disorders or current treatment with oral anticoagulants.
- Have hepatic impairment hepatic function as follows: liver enzymes (ALT and AST) > 2× ULN or > 3.5× ULN in case of liver metastasis
- Are not able to comply with regard to the known contraindications, warnings and precautions, drug-interactions and dosing recommendations of paracetamol or tramadol.
- Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
- Participated in any other investigational drug or therapy study with a non approved medication,within the previous 3 months.
- Known hypersensitivity to one of the capsules' ingredients
- Any other condition which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Hospitalier de Versailles Hôpital André Mignot Service d'Hématologie-Oncologie
Le Chesnay, 78157
Centre Oscar Lambret Département de Sénologie
Lille, 59000
Centre Léon Bérard Département de Soins de Support
Lyon, 69373
C.R.L.C Val d'Aurelle Service d'Oncologie Médicale
Montpellier, 34298
Centre Alexis Vautrin
Nancy, 54511
Centre Antoine Lacassagne
Nice, 06189
Hôpital Nord CHU Saint Etienne Centre de la douleur
Saint-Etienne, 42055
Hôpital Privé de l'Ouest Parisien Service d'Oncologie
Trappes, 78190
About this study
Official title: A Double Blind, Placebo Controlled Study of the Effect of 330 mg QD of TRO19622 in the Treatment of Chemotherapy Induced Peripheral Neuropathy
The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores.
Read the detailed description
Chemotherapy Induced Peripheral Neuropathy represents a frequent and invalidating side effect that requires treatment. Current treatment options are multiple, but none have yet demonstrated efficacy in double-blind clinical trials .
This study will provide information useful to determine the potential of TRO19622 to relieve both pain and dysesthesia which are the most common symptoms experienced by patients with peripheral neuropathy following taxane chemotherapy.
At the start of the study, patients will be randomized to one of two groups : TRO19622 (330 mg QD or placebo once a day).
Each treatment will be administered for 6 weeks. Additionally, patients will have the option to continue treatment for another 6 weeks duration.
Treatment will be administered under double-blind conditions. The product under evaluation will be administered to patients receiving the standard of care for CIPN.
- Being tested
- Olesoxime (TRO19622), Placebo Control
- Keywords
- Chemotherapy Induced Peripheral Neuropathy, TR019622, Trophos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olesoxime (TRO19622)Drug
2 capsules of TRO19622 (330 mg) once day with the noon meal
Placebo ControlDrug
Placebo Control 2 capsules once day with the noon meal
| Study group | Role | What they receive |
|---|---|---|
| TRO19622 | Experimental | 2 capsules of TRO19622 (330mg) once day with the noon meal Receives: Drug: Olesoxime (TRO19622) |
| Control | Placebo comparator | 2 capsules of placebo once day with the noon meal Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the measure of the percentage of responders defined as patients with a minimum decrease of 50 % of their maximum neuropathic pain dimension (either pain or dysesthesia) present at baseline.
Measured: The mean pain score during the last 7 days of the treatment period will be compared to the mean score of the last 7 days of the screening score period.
Secondary outcomes (11)
Assessment with respect to placebo of the effect of TRO19622 on Neuropathic Pain Inventory Score(total and by dimension)
Measured: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on Short- Form BPI
Measured: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on Quality of life questionnaire (CIPN 20)
Measured: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on Dysgueusia questionnaire
Measured: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on Quantitative Sensory Testing
Measured: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on ENMG
Measured: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on the use of rescue medication
Measured: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on safety profile
Measured: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on Global Impression of change as assessed by Investigator
Measured: V1; V2; V3; V4; V5
Assessment with respect to placebo of the effect of TRO19622 on Global Impression of change as assessed by patient
Measured: V1; V2; V3; V4; V5
Assessment with respect to placebo of the effect of TRO19622 on Hospital Anxiety and Depression scale
Measured: V0;V3;V5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivan Krakowski, MD, Principal investigator, Centre Alexis Vautrin / Département d'Oncologie Médicale/ Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876538
- Sponsor's protocol ID
- WN29851
- Other IDs
- EudraCT number: 2008-001218-26, TRO19622 CL E Q 1204-1
- Acronym
- CIPN
- Status last verified
- Nov 2016
- First submitted
- 3 Apr 2009
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Study of the Effect of 330 mg QD of TRO19622 in the Treatment of Chemotherapy Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00876538
- Acronym / sponsor ID
- CIPN / WN29851
- Keywords
- Chemotherapy Induced Peripheral Neuropathy, TR019622, Trophos
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Apr 2009 (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 purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores.
Detailed description
Chemotherapy Induced Peripheral Neuropathy represents a frequent and invalidating side effect that requires treatment. Current treatment options are multiple, but none have yet demonstrated efficacy in double-blind clinical trials .
This study will provide information useful to determine the potential of TRO19622 to relieve both pain and dysesthesia which are the most common symptoms experienced by patients with peripheral neuropathy following taxane chemotherapy.
At the start of the study, patients will be randomized to one of two groups : TRO19622 (330 mg QD or placebo once a day).
Each treatment will be administered for 6 weeks. Additionally, patients will have the option to continue treatment for another 6 weeks duration.
Treatment will be administered under double-blind conditions. The product under evaluation will be administered to patients receiving the standard of care for CIPN.
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 |
|---|---|---|
| TRO19622 | Experimental | Drug: Olesoxime (TRO19622)2 capsules of TRO19622 (330mg) once day with the noon meal |
| Control | Placebo comparator | Drug: Placebo Control2 capsules of placebo once day with the noon meal |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have signed an Informed Consent to participate to the trial before any study related procedure has taken place.
- Be >18 years and if a female with adequate contraception if of child bearing potential.
- Have paclitaxel (or other taxane) induced peripheral neuropathy assessed by the presence of a NCI-CTC version 2 neuropathy sensory grade >/= 2 .
- Peripheral neuropathy as clinically diagnosed during the neurological examination including sensitivity, motor function and deep tendon reflex assessments
- With Neuropathic pain as assessed by the presence of measurable pain perception (previous 24h)on the Likert numerical rating scale >/= 4 points at the screening visit and confirmed on DN4 with a score >/= 4 and/or Dysesthesia as assessed by the presence of measurable dysesthesia (previous 24h) on the Likert numerical rating scale >/= 4 points at the screening visit
Key exclusion criteria (21 listed)
- Have a documented neuropathy or risk factors of neuropathy which might interfere with the assessment of the severity of pain (eg, including, but not limited to, type 2 diabetes, peripheral vascular disease, B12 Vitamin deficiency, thyroid dysfunction, post surgical neuropathic pain, post-traumatic neuropathy, or neuropathy in relation with disease progression).
- Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality.
- Refractory to treatment defined as not improved, according to the Investigator, by 3 or more treatments prescribed for the current PN symptoms.
- HIV positive serology.
- History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease,including myocardial infarction, except patients with only well controlled hypertension.
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 |
|---|---|---|
| Olesoxime (TRO19622)2 capsules of TRO19622 (330 mg) once day with the noon meal | Drug | TRO19622 |
| Placebo ControlPlacebo Control 2 capsules once day with the noon meal | Drug | Control |
Primary outcome
The primary outcome will be the measure of the percentage of responders defined as patients with a minimum decrease of 50 % of their maximum neuropathic pain dimension (either pain or dysesthesia) present at baseline.
Time frame: The mean pain score during the last 7 days of the treatment period will be compared to the mean score of the last 7 days of the screening score period.
11 secondary outcomes
Assessment with respect to placebo of the effect of TRO19622 on Neuropathic Pain Inventory Score(total and by dimension)
Time frame: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on Short- Form BPI
Time frame: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on Quality of life questionnaire (CIPN 20)
Time frame: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on Dysgueusia questionnaire
Time frame: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on Quantitative Sensory Testing
Time frame: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on ENMG
Time frame: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on the use of rescue medication
Time frame: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on safety profile
Time frame: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on Global Impression of change as assessed by Investigator
Time frame: V1; V2; V3; V4; V5
Assessment with respect to placebo of the effect of TRO19622 on Global Impression of change as assessed by patient
Time frame: V1; V2; V3; V4; V5
Assessment with respect to placebo of the effect of TRO19622 on Hospital Anxiety and Depression scale
Time frame: V0;V3;V5
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 22 Nov 2016.
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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.
Ivan Krakowski, MD principal investigator
Centre Alexis Vautrin / Département d'Oncologie Médicale/ Nancy
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olesoxime (TRO19622) in people with Chemotherapy-Induced Peripheral Neuropathy, run by Hoffmann-La Roche at 8 sites 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 11 inclusion and 21 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary outcome will be the measure of the percentage of responders defined as patients with a minimum decrease of 50 % of their maximum neuropathic pain dimension (either pain or dysesthesia) present at baseline. (time frame: The mean pain score during the last 7 days of the treatment period will be compared to the mean score of the last 7 days of the screening score period.). 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 22 Nov 2016.