Mild to Moderate Diabetic Sensorimotor PolyneuropathyPhase 2/3NCT00927914
Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
A Phase 2/3 study testing Ranirestat in people with Mild to Moderate Diabetic Sensorimotor Polyneuropathy, run by Eisai Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mild to Moderate Diabetic Sensorimotor Polyneuropathy
- What is being tested?
- Ranirestat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Feb 2013
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Type 1 or Type 2, insulin-dependent or non insulin-dependent diabetes mellitus.
- Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the American Academy of Neurology criteria.
- Female subjects, who are of non-reproductive potential (>=12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal cream). Male subjects with partners of child-bearing potential must also use adequate contraception.
- Subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening.
Who cannot join
- History of diabetic foot ulcers or lower extremity amputation.
- Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms.
- Clinically significant illness which, in the opinion of the investigator, would compromise a subject's suitability to participate in the study for reasons of safety or would confound the efficacy assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21231
About this study
Official title: A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.
- Being tested
- Ranirestat, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanirestatDrug
Ranirestat 40 mg tablets
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Ranirestat 80 mg | Experimental | Two 80 mg Ranirestat tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. Receives: Drug: Ranirestat |
| Ranirestat 40 mg | Experimental | One 40 mg tablet of Ranirestat and a matching placebo, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. Receives: Drug: Ranirestat; Drug: Placebo |
| Placebo | Placebo comparator | Two placebo tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other.
Measured: 24 months
Secondary outcomes (1)
Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Diabetic Sensorimotor PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roderick Junor, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927914
- Sponsor's protocol ID
- AS3201-G000-291
- Other IDs
- 2008-002843-18, 2008
- Status last verified
- Nov 2015
- First submitted
- 24 Jun 2009
- Last updated
- 21 Feb 2019
- Results posted
- No
Publications
Polydefkis M, Arezzo J, Nash M, Bril V, Shaibani A, Gordon RJ, Bradshaw KL, Junor RW; Ranirestat Study Group. Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy. J Peripher Nerv Syst. 2015 Dec;20(4):363-71. doi: 10.1111/jns.12138.
PubMed 26313450
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
- ClinicalTrials.gov ID
- NCT00927914
- Acronym / sponsor ID
- AS3201-G000-291
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Jun 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 determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ranirestat 80 mg | Experimental | Drug: RanirestatTwo 80 mg Ranirestat tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. |
| Ranirestat 40 mg | Experimental | Drug: Ranirestat, Drug: PlaceboOne 40 mg tablet of Ranirestat and a matching placebo, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. |
| Placebo | Placebo comparator | Drug: PlaceboTwo placebo tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with Type 1 or Type 2, insulin-dependent or non insulin-dependent diabetes mellitus.
- Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the American Academy of Neurology criteria.
- Female subjects, who are of non-reproductive potential (>=12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal cream). Male subjects with partners of child-bearing potential must also use adequate contraception.
- Subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening.
Key exclusion criteria (3 listed)
- History of diabetic foot ulcers or lower extremity amputation.
- Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms.
- Clinically significant illness which, in the opinion of the investigator, would compromise a subject's suitability to participate in the study for reasons of safety or would confound the efficacy assessments.
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 |
|---|---|---|
| RanirestatRanirestat 40 mg tablets | Drug | Ranirestat 40 mg, Ranirestat 80 mg |
| PlaceboPlacebo tablets | Drug | Placebo, Ranirestat 40 mg |
Primary outcome
Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other.
Time frame: 24 months
1 secondary outcome
Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer.
Time frame: 24 months
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 21 Feb 2019.
- Derived from this study: PubMed 26313450Polydefkis M, Arezzo J, Nash M, Bril V, Shaibani A, Gordon RJ, Bradshaw KL, Junor RW; Ranirestat Study Group. Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy. J Peripher Nerv Syst. 2015 Dec;20(4):363-71. doi: 10.1111/jns.12138.
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.
Roderick Junor study director
Eisai Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ranirestat in people with Mild to Moderate Diabetic Sensorimotor Polyneuropathy, run by Eisai Inc. at 1 site in United States.
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 4 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 21 Feb 2019. 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 United States. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00927914, which also lists 1 linked publication.
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 21 Feb 2019.