Diabetic NeuropathyPhase 1NCT00110500
Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy
A Phase 1 study testing hVEGF-A in people with Diabetic Neuropathy, run by Sangamo Therapeutics at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection to subjects with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- hVEGF-A
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jan 2008
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months prior to the study.
- Have received a diagnosis of mild to moderate sensori-motor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). This type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. Subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.
- Be an adult male or female between the ages of 18 and 65.
- Be able and willing to read and sign a consent form.
- Be willing to participate in the study as an outpatient and make the required visits to the study center during the treatment and after the treatment periods
- Meet and follow the study requirements.
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- Have abnormal signs of sensori-motor diabetic neuropathy based on a rating scale that is based on questions and a physical exam called the Neuropathy Impairment Score-Lower Limb (NIS-LL) clinical scoring system.
- Have abnormal results on specialized nerve testing in the legs. The study doctor or study staff will do this specialized nerve testing with a Nerve Conduction Test and Quantitative Sensory Testing, both of which you will read about below.
- Have measurable sural nerve responses in both legs
- Have an HgbA1C level that is 10% or lower, with stable blood sugar control for at least 3 months. The study doctor will check this.
- Have an eye exam by an eye doctor to rule out the presence of abnormal growth of blood vessels or proliferative diabetic retinopathy (eye complications of diabetes).
- Have a normal, complete blood count. The study doctor will check this.
- Have a normal urine test.
- If female, be: (a) postmenopausal or (b) surgically sterile or (c) use two forms of birth control and have a negative pregnancy test within 3 days of receiving the study drug.
- If male and able to make a female pregnant, use an accepted form of birth control.
- Have had up-to-date screening tests for cancer as recommended by the American Cancer Society. These tests include a PSA blood test for prostate cancer (for males over age 45), a pap smear for cervical cancer (for females), a mammogram (for females over age 40), and a flexible sigmoidoscopy for colon cancer (if over age 50). To be in this study, you must have written proof of normal test results within the last 12 months. If these screening tests show you have cancer, you will not be able to be in the study.
- Have a normal chest X-ray without evidence of heart enlargement or congestive heart failure.
Who cannot join
- Subjects with the following are NOT eligible to participate in this study:
- Have moderate to severe ischemic heart disease, any history of congestive heart failure or have had a myocardial infarction (heart attack) within the previous 6 months.
- Have chronic foot or leg ulcers for >1 month, gangrene in the lower extremity, or any previous amputation of the lower extremity.
- Have symptoms of intermittent claudication (or leg pain during exercise associated with peripheral artery disease) and/or an ankle brachial index (or a calculation of the difference between arm and leg blood pressures) of less than < 0.75.
- Have a history of cancer within the past 10 years (except curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
- Be pregnant, breastfeeding, or a man or woman of reproductive potential (able to make babies) not using an accepted form of birth control.
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- Expect to require any surgery within 4 weeks of receiving the study drug.
- Have a condition that increases your risk of bleeding (for example, hemophilia or a similar disorder) or requires treatment with warfarin, clopidogrel, or aspirin (at least 325 mg each day) within 2 weeks before you receive the study drug and within 24 hours afterwards.
- Have had a stroke with bleeding in the brain within the last 12 months.
- Have had bleeding from the gastrointestinal tract (esophagus, stomach, duodenum, intestines, rectum) within the last 12 months. If you have ever had bleeding from the large intestine or rectum, you will need to have had a negative colonoscopy after that episode and within the last 3 years.
- Have any other condition that, in the opinion of the study doctor, might cause problems during the study (for example, affect your health or study test results).
- Be participating in another research study while you are in this study or within 30 days of receiving the study drug.
- Have colon polyps. If you have history of benign colonic polyps that have been removed, you must have evidence of a normal colonoscopy within the last 12 months.
- Have an inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease).
- Have an active infection requiring antibiotics that you take by swallowing or is administered directly into a vein. If you had an infection in the past, you must not be receiving treatment for that infection within 2 weeks of receiving the study drug.
- Have abnormal kidney function.
- Require any drug that depresses your immune system (such as methotrexate, cyclophosphamide, or cyclosporine) when you receive the study drug and for 30 days afterwards.
- Have a known disorder that affects your immune system (such as HIV/AIDS, HBV, HCV, sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).
- Be using oral, injectable, or intravenous (directly into the vein) corticosteroids (such as prednisone) within 30 days of starting the study.
- Have a history of drug addiction (not including smoking) within 12 months of the start of the study.
- Have any psychiatric (mental) or addictive disorders that would prevent the subject from being able to read and sign a consent form.
- Have neuropathy of the extremities that is caused by a condition other than diabetes (for example, alcohol abuse and liver or renal disease).
- Have received gene transfer agents within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose-Escalation Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy
The purpose of this study is to evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection to subjects with diabetic neuropathy.
Read the detailed description
Primary objective:
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection. To determine the maximum tolerated dose (MTD) of a single treatment by intramuscular injection by SB-509.
Secondary objective:
To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms, neurological examination, and lower extremity electrophysiological testing.
- Conditions
- Diabetic Neuropathy
- Being tested
- hVEGF-A
- Keywords
- Diabetes, Neuropathy
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hVEGF-AGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection
To determine the maximum tolerated dose (MTD) of a single treatment by intramuscular injection by SB-509.
Secondary outcomes (1)
To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms, neurological examination, and lower extremity electrophysiological testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sangamo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110500
- Sponsor's protocol ID
- SB-509-0401
- Status last verified
- Jun 2011
- First submitted
- 9 May 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00110500
- Acronym / sponsor ID
- SB-509-0401
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetes, Neuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sangamo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 May 2005 (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 evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection to subjects with diabetic neuropathy.
Detailed description
Primary objective:
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection. To determine the maximum tolerated dose (MTD) of a single treatment by intramuscular injection by SB-509.
Secondary objective:
To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms, neurological examination, and lower extremity electrophysiological testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Have a clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months prior to the study.
- Have received a diagnosis of mild to moderate sensori-motor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). This type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. Subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.
- Be an adult male or female between the ages of 18 and 65.
- Be able and willing to read and sign a consent form.
- Be willing to participate in the study as an outpatient and make the required visits to the study center during the treatment and after the treatment periods
Key exclusion criteria (23 listed)
- Have moderate to severe ischemic heart disease, any history of congestive heart failure or have had a myocardial infarction (heart attack) within the previous 6 months.
- Have chronic foot or leg ulcers for >1 month, gangrene in the lower extremity, or any previous amputation of the lower extremity.
- Have symptoms of intermittent claudication (or leg pain during exercise associated with peripheral artery disease) and/or an ankle brachial index (or a calculation of the difference between arm and leg blood pressures) of less than < 0.75.
- Have a history of cancer within the past 10 years (except curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
- Be pregnant, breastfeeding, or a man or woman of reproductive potential (able to make babies) not using an accepted form of birth control.
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 |
|---|---|---|
| hVEGF-A | Genetic | – |
Primary outcome
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection
To determine the maximum tolerated dose (MTD) of a single treatment by intramuscular injection by SB-509.
1 secondary outcome
To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms, neurological examination, and lower extremity electrophysiological testing.
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 8 Jun 2011.
- Sangamo Biosciences websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hVEGF-A in people with Diabetic Neuropathy, run by Sangamo Therapeutics 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 17 inclusion and 23 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 8 Jun 2011. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection. 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 8 Jun 2011.