Diabetic Neuropathic PainPhase 2NCT01345045
A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain
A Phase 2 study testing ABT-639 and pregabalin in people with Diabetic Neuropathic Pain, run by AbbVie (prior sponsor, Abbott) at 35 sites in 5 countries.
Trial summary
People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathic Pain
- What is being tested?
- ABT-639 and pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 35 sitesin 5 countries
- Study dates
- Apr 2011to Oct 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
- Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.
Who cannot join
- Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
- A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
- Subject has clinically significant abnormalities in clinical laboratory tests.
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
United States19 sites
Site Reference ID/Investigator# 51806
Altoona, Pennsylvania, 16602
Site Reference ID/Investigator# 51946
Anaheim, California, 92801
Site Reference ID/Investigator# 51804
Brockton, Massachusetts, 02301
Site Reference ID/Investigator# 51079
Clearwater, Florida, 33765
Site Reference ID/Investigator# 51548
Dallas, Texas, 75231
Site Reference ID/Investigator# 51271
Flushing, New York, 11365
Site Reference ID/Investigator# 51076
Hialeah, Florida, 33012
Site Reference ID/Investigator# 51945
Hollywood, Florida, 33021
Site Reference ID/Investigator# 51807
Little Rock, Arkansas, 72204
Site Reference ID/Investigator# 51468
Long Beach, California, 90806
Site Reference ID/Investigator# 51077
Ocala, Florida, 34471
Site Reference ID/Investigator# 51302
Omaha, Nebraska, 68131
Site Reference ID/Investigator# 51078
Orlando, Florida, 32806
Site Reference ID/Investigator# 52743
Portland, Oregon, 97239
Site Reference ID/Investigator# 51269
Renton, Washington, 98055
Site Reference ID/Investigator# 51263
St Louis, Missouri, 63141
Site Reference ID/Investigator# 51268
St Louis, Missouri, 63141
Site Reference ID/Investigator# 51265
Tipton, Pennsylvania, 16684
Site Reference ID/Investigator# 52744
Walnut Creek, California, 94598
Czechia6 sites
Site Reference ID/Investigator# 51425
Hradec Králové, 500 03
Site Reference ID/Investigator# 51426
Mor Ostrava, 702 00
Site Reference ID/Investigator# 51424
Olomouc, 77900
Site Reference ID/Investigator# 51428
Prague, 100 00
Site Reference ID/Investigator# 51423
Prague, 160 00
Site Reference ID/Investigator# 51427
Zlín, 760 01
Germany4 sites
Site Reference ID/Investigator# 51503
Berlin, 10115
Site Reference ID/Investigator# 51642
Düsseldorf, 40225
Site Reference ID/Investigator# 51502
Mainz, D - 55116
Site Reference ID/Investigator# 52346
Münster, 48145
Mexico4 sites
Site Reference ID/Investigator# 51505
Guadalajara, Jal., C.P. 44130
Site Reference ID/Investigator# 51504
Mexico City, C.P. 11650
Site Reference ID/Investigator# 51522
Monterrey, N.L., C.P. 64000
Site Reference ID/Investigator# 51506
Monterrey, N.L., C.P. 64460
France2 sites
Site Reference ID/Investigator# 51924
Le Creusot, 71200
Site Reference ID/Investigator# 51925
Vénissieux, 69200
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain
People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
- Conditions
- Diabetic Neuropathic Pain
- Being tested
- ABT-639, pregabalin, Placebo
- Keywords
- Diabetic Asymmetric Polyneuropathy, Symmetric Diabetic Proximal Motor Neuropathy, Diabetic Mononeuropathy Simplex,, Diabetic Autonomic Neuropathy,, Diabetic Amyotrophy, Mononeuropathy, Diabetic Neuropathy, Asymmetric Diabetic Proximal Motor Neuropathy, Diabetic Polyneuropathy, Painful, Diabetic Mononeuropathy, Neuralgia
- Medical subject headings
- Diabetic Neuropathies, Mononeuropathies, Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-639Drug
ABT-639 Twice Daily for six weeks.
pregabalinDrug
Also called Lyrica
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
PlaceboDrug
Placebo twice daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ABT-639 | Experimental | ABT-639 twice daily for 6 weeks Receives: Drug: ABT-639 |
| pregabalin | Active comparator | pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study Receives: Drug: pregabalin |
| Placebo | Placebo comparator | Placebo twice daily for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
Daily questions asked on a hand held diary
Measured: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)
Secondary outcomes (3)
Patient's Global Impression of Change
Paper questionnaire
Measured: Week 2, Week 4 and Week 6 (End of Study)
Brief Pain Inventory (BPI) (short form) including Severity and Interference
Paper questionnaire
Measured: At each visit up to Week 6 (end of Study)
Neuropathic Pain Symptom Inventory (NPSI)
Paper questionnaire
Measured: Baseline, Week 2, Week 4 and Week 6 (end of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
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 Diabetic Neuropathic PainStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachel Duan, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345045
- Sponsor's protocol ID
- M11-891
- Other IDs
- 2010-024359-99
- Status last verified
- Jan 2013
- First submitted
- 28 Apr 2011
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-2020. doi: 10.1097/j.pain.0000000000000263.
PubMed 26067585
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01345045
- Acronym / sponsor ID
- M11-891
- Conditions
- Diabetic Neuropathic Pain
- Keywords
- Diabetic Asymmetric Polyneuropathy, Symmetric Diabetic Proximal Motor Neuropathy, Diabetic Mononeuropathy Simplex,, Diabetic Autonomic Neuropathy,, Diabetic Amyotrophy, Mononeuropathy, Diabetic Neuropathy, Asymmetric Diabetic Proximal Motor Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Apr 2011 (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.
People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABT-639 | Experimental | Drug: ABT-639ABT-639 twice daily for 6 weeks |
| pregabalin | Active comparator | Drug: pregabalinpregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice daily for 6 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
- Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.
Key exclusion criteria (3 listed)
- Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
- A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
- Subject has clinically significant abnormalities in clinical laboratory tests.
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 |
|---|---|---|
| ABT-639ABT-639 Twice Daily for six weeks. | Drug | ABT-639 |
| pregabalinAlso: Lyricapregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study. | Drug | pregabalin |
| PlaceboPlacebo twice daily for 6 weeks. | Drug | Placebo |
Primary outcome
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
Time frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)
Daily questions asked on a hand held diary
3 secondary outcomes
Patient's Global Impression of Change
Time frame: Week 2, Week 4 and Week 6 (End of Study)
Brief Pain Inventory (BPI) (short form) including Severity and Interference
Time frame: At each visit up to Week 6 (end of Study)
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Baseline, Week 2, Week 4 and Week 6 (end of Study)
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 Jan 2013.
- Derived from this study: PubMed 26067585Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-2020. doi: 10.1097/j.pain.0000000000000263.
Related trials for Diabetic Neuropathic Pain
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Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
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Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
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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.
Rachel Duan, MD study director
AbbVie
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-639 and pregabalin in people with Diabetic Neuropathic Pain, run by AbbVie (prior sponsor, Abbott) at 35 sites in 5 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 2 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 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Czechia, Germany, Mexico, France. 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 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?
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary (time frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)). 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 NCT01345045, 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 8 Jan 2013.