A clinical study to test how safe, tolerable and effective MT-8554 is for patients with Painful Diabetic Peripheral Neuropathy
- Conditions
- Painful Diabetic Peripheral Neuropathy (DPN)MedDRA version: 20.0 Level: LLT Classification code 10012683 Term: Diabetic peripheral neuropathy System Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-002571-10-DE
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation (MTPC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 61
1. Written informed consent obtained to participate in this study after reading the participant information sheet and informed consent form and after having the opportunity to discuss the study with the Investigator or designee.
2. Male subjects and female subjects aged =18 years at Screening.
3. Subjects and partners who agree to use contraception (as defined in the Protocol section 4.7.1) throughout the study.
4. In the Investigator’s opinion, the subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the Protocol restrictions and requirements.
5. Subjects with diabetes mellitus (type 1 or 2) with distal symmetric chronic sensorimotor painful peripheral neuropathy as confirmed by a score of >2 points on Section B (physical examination) of the Michigan Neuropathy Screening Instrument.
6. A history of pain for at least 6 months and =7 years attributed to DPN at the time of Screening.
7. For Part 2 only: A baseline 24-hour daily API score =4 and =8 in both lower limbs as measured on an 11-point pain intensity NRS. The baseline score is the calculated median of the 24-hour daily API scores during the 7 days prior to randomisation for Treatment Period 1. In Part 2, the subject must record at least 4 assessments of the 24 hour daily API score during the 7-day placebo run-in period in their eDiary. However, subjects who experience a >30% variation in daily API score during Placebo Baseline 1 will be excluded.
8. Subjects willing to withdraw from their neuropathy medications prior to Visit 2 and for the whole duration of the study. Acetaminophen/paracetamol is allowable as rescue medication if dosed at up to 3 g/day, if required for pain relief. Should acetaminophen/ paracetamol provide insufficient relief from pain then use of metamizole in single doses up to 1 g and up to the maximum daily dose of 4 g is allowed. The label restrictions for acetaminophen/paracetamol and metamizole will apply.
9. Diabetes which did not require a change in anti-diabetic therapy in the 2 months prior to Screening.
10. For Part 2 only: Glycosylated haemoglobin (HbA1c) 11. A body mass index (Quetelet index) ranging from 18 to 45 kg/m2 (inclusive) at Screening.
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 58
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Other chronic pain conditions not associated with DPN that may confound the assessment of neuropathic pain. However, the subject will not be excluded if:
• The pain condition is located at a different region of the body (other then lower limbs), and
• The pain intensity of this condition is not greater than the pain intensity of DPN, and
• The subject can assess pain due to DPN independently of their other pain condition.
2. Other causes of neuropathy or lower extremity pain which may include, but not be limited to:
a. Lower extremity pain of any severity caused by: gout, bursitis, or fasciitis.
b. Past medical history or known current medical condition of diffuse peripheral neuropathy caused by alcoholism, malignancy, human immunodeficiency virus (HIV), syphilis, drug abuse, peripheral ischaemia, Vitamin B12 deficiency, monoclonal gammopathy, hypothyroidism, liver disease, chemotherapy or radiation therapy.
c. Focal neuropathy in the lower extremities including nerve entrapment or local trauma.
d. Acute or chronic inflammatory polyradiculopathy.
e. Multiple sclerosis or other conditions associated with central neuropathic pain.
f. Pain associated with distal limb ischaemia including intermittent claudication.
3. Current or known history of complex regional pain syndrome or trigeminal neuralgia.
4. Subjects who have been on pain treatment with strong opioids in the previous year, >4 different drug treatments in the previous year, or a current combination of >3 drugs for neuropathic pain.
5. Use of the following drugs within [x] weeks prior to Visit 2:
a. [12 weeks] Capsaicin.
b. [4 weeks] Lidocaine patch.
c. [2 weeks] Antidepressants, anticonvulsants or mexiletine. Opioids or morphinomimetics. Alpha lipoic acid or Vitamin B supplements.
d. [1 week] Acetylsalicylic acid except up to 325 mg/day post-myocardial infarction or prevention, transient ischaemic attack prophylaxis. Benzodiazepines, other than zolpidem 5 mg used for sleep disorders.
6. Use of non-drug therapies or procedures for the relief of pain of DPN within 1 week prior to Visit 2. Nerve blocks are not to be performed within the last 8 weeks prior to Visit 2.
7. Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drug(s).
8. Current diabetic foot ulcer.
9. Lower extremity amputations other than toes.
10. History of alcohol, solvent or drug use disorder.
11. For Part 2 only: A change in symptomatology between preserved small fibre function”, and non-preserved small fibre function” phenotype from Screening to Baseline Visit, based on QST results.
12. Subjects who have participated in a clinical study of any IMP (other then IMP) within 12 weeks (from last administration) prior to Screening or who are currently participating in another clinical study.
13. Pregnancy, lactation or a positive serum beta human chorionic gonadotropin (hCG) level, or intention to become pregnant or to breast-feed from the Screening Visit until 3 months after the last dose of IMP.
14. Cl
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method