Diabetic Neuropathy, PainfulPhase 2NCT01564459
Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021)
A Phase 2 study testing MK-6096 in people with Diabetic Neuropathy, Painful, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the treatment of painful diabetic neuropathy (PDN) in adults. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- MK-6096
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2012to 18 Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Has a primary diagnosis of painful diabetic neuropathy (PDN) for at least 6 months.
- Is able to understand \& use an electronic diary to complete daily questionnaires.
- If female of reproductive potential, agrees to use acceptable contraception from Screening through to at least 2 weeks after last dose of study drug.
- Is on a stable dose of antihyperglycemic treatment for at least 1 month, with hemoglobin A1C level of no more than 11%.
- If taking an allowable around-the-clock medication for chronic pain, has been on a stable dose for at least 1 month \& agrees to stay on same dose during the study.
- Agrees to not start therapy with opioids, pregabalin, gabapentin, duloxetine or any other medications used to treat neuropathic pain during the study.
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- Has a regular bedtime of before 1 AM (01:00).
- Agrees to limit alcohol consumption to no more than 3 drinks a day, with no drinks within 3 hours before bedtime. One drink is defined as: 1) 12 ounces of beer; 2) 4 ounces of wine; or 3) 1 ounce of liquor (80 proof or 40% alcohol).
- Agrees to limit caffeine consumption to no more than 5 standard 6-oz. cups of caffeinated beverages or no more than 600 mg caffeine a day, with no caffeinated beverages after 4 PM (16:00).
- Agrees to maintain a relatively consistent level of activity throughout the study.
Who cannot join
- Is pregnant or breastfeeding, or expects to become pregnant during the study.
- Expects to donate eggs or sperm during the study or within 90 days after last dose of study drug.
- Has had ineffective treatment with more than 3 neuropathic pain drugs.
- Anticipates need for surgery during the study.
- Has another existing type of pain that is as severe as or greater than the pain under study OR is not able to distinguish the pain under study from another existing pain condition.
- Has post herpetic neuralgia (PHN); small fiber predominant neuropathy (SFN); idiopathic sensory neuropathy (ISN); complex regional pain syndrome; sensory neuropathies; or pain caused by radiation/chemotherapy/amputation/human immunodeficiency virus (HIV) infection.
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- Has received a nerve block for pain within past 6 weeks.
- Has a history of pernicious anemia, untreated hypothyroidism, or amputations other than toes.
- Has a history of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep-related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness, or difficulty sleeping due to a medical condition (i.e. asthma, Gastroesophageal Reflux Disease (GERD)) other than PDN.
- Has any history of a neurological disorder, including: seizure disorder, stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness.
- Has a current evidence or history within past 6 months of unstable cardiovascular disorder, including: acute coronary syndrome; unstable angina; congestive heart failure; cardiogenic syncope; cardiomyopathy; or symptomatic arrhythmia.
- Has a Body Mass Index (BMI) of more than 40 kg/m^2.
- Has any of the following: 1) evidence of ongoing depression or suicidality; 2) a lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder; 3) a psychiatric condition requiring treatment with a prohibited medication; or 3) other current psychiatric condition that might interfere with ability to participate in the study.
- Is at imminent risk of self-harm or harm to others.
- Has a history of substance abuse or dependence. Substances include alcohol, marijuana, hypnotics, other prescription drugs, \& drugs of abuse, but exclude nicotine.
- Has a history of malignant cancer within past 5 years, except for adequately treated basal cell or squamous cell skin cancer or cervical cancer.
- Has a history of hypersensitivity or reaction to more than 2 chemical classes of drugs, including prescription \& over-the-counter medications.
- Is currently participating or has participated in an investigational study of a compound or device within past 30 days OR is not willing to refrain from participating in another study during this study.
- Has a history of travel across 3 or more time zones or shift work (permanent night shift or rotating day/night shift work) within past 2 weeks, OR anticipates need to travel across 3 or more time zones during the study.
- Has donated blood products or had more than 300 mL of blood drawn within past 8 weeks; has received blood products within past 30 days; OR intends to donate or receive blood products during the study.
- Has previously participated in a study of MK-6096.
- Is an employee and/or a family member of one of the investigators, study staff, or Merck.
About this study
Official title: A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 in Patients With Painful Diabetic Neuropathy
The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the treatment of painful diabetic neuropathy (PDN) in adults.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- MK-6096, Placebo
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6096Drug
MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
PlaceboDrug
Matching compressed tablets, taken once daily at bedtime for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| MK-6096 10 mg→MK-6096 10 mg | Experimental | Participants receive MK-6096 10 mg during run-in once daily for 1 week and receive MK-6096 10 mg once daily for 2 weeks during double-blind treatment period. Receives: Drug: MK-6096 |
| MK-6096→Placebo | Placebo comparator | Participants receive MK-6096 10 mg during run-in once daily for 1 week and receive placebo once daily for 2 weeks during double-blind treatment period. Receives: Drug: MK-6096; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Efficacy Failure (TTEF) - Primary Responders
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥30% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for primary responders was summarized.
Measured: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)
Percentage of Participants Who Experienced 1 or More Adverse Events (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE.
Measured: up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
Percentage of Participants Who Were Discontinued Form the Study Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. Adverse Events that were reported as the cause for discontinuation of the study drug were recorded.
Measured: up to 7 days for run-in; up to 14 days for active treatment period)
Secondary outcomes (3)
TTEF - All Responders
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥20% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for responders was summarized.
Measured: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)
Change in Pain Intensity Scores - Primary Responders
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant's average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the primary responders.
Measured: End of Single-Blind Period (Baseline) and end of Double-Blind Period
Change in Pain Intensity Scores - All Responders
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant's average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the responders.
Measured: End of Single-Blind Period (Baseline) and end of Double-Blind Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study start26 Mar 2012
- Primary completion18 Apr 2013
- Study completion18 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy, PainfulStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564459
- Sponsor's protocol ID
- 6096-021
- Status last verified
- Oct 2018
- First submitted
- 28 Feb 2012
- Last updated
- 7 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Joseph Herring W, Ge JY, Jackson S, Assaid C, Connor KM, Michelson D. Orexin Receptor Antagonism in Painful Diabetic Neuropathy: A Phase 2 Trial With Filorexant. Clin J Pain. 2018 Jan;34(1):37-43. doi: 10.1097/AJP.0000000000000503.
PubMed 28448426
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 in Patients With Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT01564459
- Acronym / sponsor ID
- 6096-021
- Conditions
- Diabetic Neuropathy, Painful
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2012 (actual)
- Primary completion
- 18 Apr 2013 (actual)
- Study completion
- 18 Apr 2013 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Posted 10 Aug 2016
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 safety and effectiveness of MK-6096 in the treatment of painful diabetic neuropathy (PDN) in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-6096 10 mg→MK-6096 10 mg | Experimental | Drug: MK-6096Participants receive MK-6096 10 mg during run-in once daily for 1 week and receive MK-6096 10 mg once daily for 2 weeks during double-blind treatment period. |
| MK-6096→Placebo | Placebo comparator | Drug: MK-6096, Drug: PlaceboParticipants receive MK-6096 10 mg during run-in once daily for 1 week and receive placebo once daily for 2 weeks during double-blind treatment period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has a primary diagnosis of painful diabetic neuropathy (PDN) for at least 6 months.
- Is able to understand \& use an electronic diary to complete daily questionnaires.
- If female of reproductive potential, agrees to use acceptable contraception from Screening through to at least 2 weeks after last dose of study drug.
- Is on a stable dose of antihyperglycemic treatment for at least 1 month, with hemoglobin A1C level of no more than 11%.
- If taking an allowable around-the-clock medication for chronic pain, has been on a stable dose for at least 1 month \& agrees to stay on same dose during the study.
Key exclusion criteria (22 listed)
- Is pregnant or breastfeeding, or expects to become pregnant during the study.
- Expects to donate eggs or sperm during the study or within 90 days after last dose of study drug.
- Has had ineffective treatment with more than 3 neuropathic pain drugs.
- Anticipates need for surgery during the study.
- Has another existing type of pain that is as severe as or greater than the pain under study OR is not able to distinguish the pain under study from another existing pain condition.
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 |
|---|---|---|
| MK-6096MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days. | Drug | MK-6096 10 mg→MK-6096 10 mg, MK-6096→Placebo |
| PlaceboMatching compressed tablets, taken once daily at bedtime for 14 days. | Drug | MK-6096→Placebo |
Primary outcome
Time to Efficacy Failure (TTEF) - Primary Responders
Time frame: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥30% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for primary responders was summarized.
Percentage of Participants Who Experienced 1 or More Adverse Events (AE)
Time frame: up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE.
Percentage of Participants Who Were Discontinued Form the Study Due to an AE
Time frame: up to 7 days for run-in; up to 14 days for active treatment period)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. Adverse Events that were reported as the cause for discontinuation of the study drug were recorded.
3 secondary outcomes
TTEF - All Responders
Time frame: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)
Change in Pain Intensity Scores - Primary Responders
Time frame: End of Single-Blind Period (Baseline) and end of Double-Blind Period
Change in Pain Intensity Scores - All Responders
Time frame: End of Single-Blind Period (Baseline) and end of Double-Blind Period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28448426Joseph Herring W, Ge JY, Jackson S, Assaid C, Connor KM, Michelson D. Orexin Receptor Antagonism in Painful Diabetic Neuropathy: A Phase 2 Trial With Filorexant. Clin J Pain. 2018 Jan;34(1):37-43. doi: 10.1097/AJP.0000000000000503.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-6096 in people with Diabetic Neuropathy, Painful, run by Merck Sharp & Dohme LLC.
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 10 inclusion and 22 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 10 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Efficacy Failure (TTEF) - Primary Responders (time frame: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)). The study lists 3 primary outcomes in all. 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 NCT01564459, 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 7 Nov 2018.