Painful Diabetic Peripheral NeuropathyPhase 2NCT03172598
Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy
A Phase 2 study testing MT-8554 low dose, MT-8554 middle dose and MT-8554 high dose in people with Painful Diabetic Peripheral Neuropathy, run by Tanabe Pharma Corporation at 3 sites in 3 countries.
Trial summary
A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy
- What is being tested?
- MT-8554 low dose, MT-8554 middle dose and MT-8554 high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 Jul 2017to 8 Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects and female subjects aged ≥18 years
- Subjects who have a history of pain at least 6 months and ≤7 years attributed to diabetic peripheral neuropathy
- A body mass index ranging from 18 to 45 kg/m2
Who cannot join
- Subjects who have participated in a clinical study of any IMP (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study
- Unstable or uncontrolled diabetes
- Clinically significant 12-lead ECG abnormalities
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase IIa, Multi-Centre, Randomised, Double-Blind, Cross-Over, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Incorporating an Open Label Pilot Arm
A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Being tested
- MT-8554 low dose, MT-8554 middle dose, MT-8554 high dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-8554 low doseDrug
Capsule
MT-8554 middle doseDrug
Capsule
MT-8554 high doseDrug
Capsule
PlaceboDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| MT-8554 low dose | Experimental | Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period. Receives: Drug: MT-8554 low dose |
| MT-8554 middle dose | Experimental | Patients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period. Receives: Drug: MT-8554 middle dose |
| MT-8554 high dose | Experimental | Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period. Receives: Drug: MT-8554 high dose |
| MT-8554, then placebo | Experimental | The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase Receives: Drug: MT-8554 low dose; Drug: MT-8554 middle dose; Drug: MT-8554 high dose; Drug: Placebo |
| Placebo, then MT-8554 | Experimental | The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase Receives: Drug: MT-8554 low dose; Drug: MT-8554 middle dose; Drug: MT-8554 high dose; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as measured by vital signs and Adverse Events
Number of participants with potentially clinically important vital sign measurements or tolerability issues
Measured: Up to Day 22
Efficacy as measured by reduction in pain using a numerical rating scale.
Pain reduction using an 11-point numerical rating scale
Measured: Up to Day 49
Secondary outcomes (2)
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Number of participants with potentially clinically important ECG findings
Measured: Up to Day 49
Plasma concentration of MT-8554
Maximum Observed Plasma Concentration (Cmax)
Measured: Up to Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start25 Jul 2017
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Peripheral NeuropathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Europe Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172598
- Sponsor's protocol ID
- MT-8554-E06
- Status last verified
- Dec 2025
- First submitted
- 29 May 2017
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multi-Centre, Randomised, Double-Blind, Cross-Over, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Incorporating an Open Label Pilot Arm
- ClinicalTrials.gov ID
- NCT03172598
- Acronym / sponsor ID
- MT-8554-E06
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 1 Jun 2017 (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.
A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MT-8554 low dose | Experimental | Drug: MT-8554 low dosePatients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period. |
| MT-8554 middle dose | Experimental | Drug: MT-8554 middle dosePatients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period. |
| MT-8554 high dose | Experimental | Drug: MT-8554 high dosePatients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period. |
| MT-8554, then placebo | Experimental | Drug: MT-8554 low dose, Drug: MT-8554 middle dose, Drug: MT-8554 high dose, Drug: PlaceboThe study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase |
| Placebo, then MT-8554 | Experimental | Drug: MT-8554 low dose, Drug: MT-8554 middle dose, Drug: MT-8554 high dose, Drug: PlaceboThe study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male subjects and female subjects aged ≥18 years
- Subjects who have a history of pain at least 6 months and ≤7 years attributed to diabetic peripheral neuropathy
- A body mass index ranging from 18 to 45 kg/m2
Key exclusion criteria (3 listed)
- Subjects who have participated in a clinical study of any IMP (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study
- Unstable or uncontrolled diabetes
- Clinically significant 12-lead ECG abnormalities
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 |
|---|---|---|
| MT-8554 low doseCapsule | Drug | MT-8554 low dose, MT-8554, then placebo, Placebo, then MT-8554 |
| MT-8554 middle doseCapsule | Drug | MT-8554 middle dose, MT-8554, then placebo, Placebo, then MT-8554 |
| MT-8554 high doseCapsule | Drug | MT-8554 high dose, MT-8554, then placebo, Placebo, then MT-8554 |
| PlaceboCapsule | Drug | MT-8554, then placebo, Placebo, then MT-8554 |
Primary outcome
Safety and Tolerability as measured by vital signs and Adverse Events
Time frame: Up to Day 22
Number of participants with potentially clinically important vital sign measurements or tolerability issues
Efficacy as measured by reduction in pain using a numerical rating scale.
Time frame: Up to Day 49
Pain reduction using an 11-point numerical rating scale
2 secondary outcomes
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Time frame: Up to Day 49
Plasma concentration of MT-8554
Time frame: Up to Day 49
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 Dec 2025.
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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.
General Manager study director
Tanabe Pharma Europe Ltd
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-8554 low dose, MT-8554 middle dose and MT-8554 high dose in people with Painful Diabetic Peripheral Neuropathy, run by Tanabe Pharma Corporation at 3 sites in 3 countries.
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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Hungary, Poland. 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. 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?
Safety and Tolerability as measured by vital signs and Adverse Events (time frame: Up to Day 22). The study lists 2 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 22 Dec 2025.