A double blind, placebo controlled study of the effect of 330mg QD of TRO19622 in the treatment of Chemotherapy Induced Peripheral Neuropathy.
- Conditions
- Symptoms of chemotherapy induced peripheral neuropathyMedDRA version: 9.1Level: LLTClassification code 10036109Term: Polyneuropathy due to drugs
- Registration Number
- EUCTR2008-001218-26-FR
- Lead Sponsor
- TROPHOS SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- Be a male >18 years or 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 symptoms of:
• 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.
- 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:
1. 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.
2. Have an electrocardiogram (ECG) at Baseline without any clinically significant abnormality.
3. Have an expected survival rate of > 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Related to neuropathic pain
a) 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).
b) Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality.
c) Refractory to treatment defined as not improved , according to the investigator,by 3 or more treatments prescribed for the current PN symptoms.
2. Related to efficacy and safety evaluation
a) HIV positive serology.
b) History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease,including myocardial infarction, except patients with only well controlled hypertension.
c) Have had prior (within the past 6 months) or have concurrent neurotoxic drugs (e.g., but not limited to, docetaxel, cisplatin, vincristine, vinblastine, cytarabine, thalidomide, bortezomib, or procarbazine, capecitabine, navelbine).
d) Have a current medication that may have a similar mechanism of action as TRO19622:acetyl-L-carnitine
e) Have a current medication that could interfere with TRO19622 pharmacokinetics: tamoxifene
f) Have current medications that could interfere with TRO19622 absorption such as ezetimibe,bile salts chelators, fibrates, phytosterols, fish oils.
g) Have a current medication of lipid lowering agents other than statins.
h) Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
i) 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)
j) Be pregnant female or lactating.
k) Have renal impairment defined as blood creatinine > 1:5 x upper limit of normal (ULN)
l) Hemostasis disorders or current treatment with oral anticoagulants.
m) Have hepatic impairment hepatic function as follows: liver enzymes (ALT and AST) > 2 x ULN or > 3:5 x ULN in case of liver metastatis
n) Are not able to comply with regard to the known contraindications, warnings and precautions,drug-interactions and dosing recommendations of paracetamol or tramadol.
o) Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
p) Participated in any other investigational drug or therapy study with a non approved medication, within the previous 3 months.
q) Known hypersensitivity to one of the capsules’ ingredients
r) Any other condition which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Evaluation of the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and based on the separate assessment of pain and dysesthesia scores<br> ;Secondary Objective: - Compare the efficacy on Neuropathic Pain Inventory Score on Dysgueusia if present ,Quality of life, Quantitative Sensory Testing , ENMG,safety profil, pain time course of TRO19622 versus placebo ;Primary end point(s): Effect will be measured on 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.
- Secondary Outcome Measures
Name Time Method