A multi-center, open-label trial to assess the long-term safety and efficacy of SPM 927 in subjects with painful diabetic neuropathy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 360

Inclusion Criteria

A subject is considered eligible for participation in the trial if the following inclusion criteria are satisfied at Visits 1 and 2.0:
1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
2. Subject is willing and able to comply with all trial requirements, including the completion of trial questionnaires.
3. Subject is male or female, =18 years of age.
4. Subject has symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II). Subjects who have had symptoms of painful diabetic neuropathy for longer than 5 years may be enrolled after consultation with the medical monitor.
5. Subject has HbA1c levels <12% with optimized diabetic control (best effort to achieve best control) for at least 3 months prior to Visit 1.
6. Subject has at least moderate pain that is defined as an average pain intensity of =4 on an 11 point Likert scale (0-10) during the 7 days prior to Visit 2, where at least 4 out of the 7 days have both the morning and evening scores recorded in the subject diary.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject is not eligible for participation in the trial if any of the following exclusion criteria are met at Visit 1:
1. Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.
2. Subject has participated in another trial of an investigational drug (or a medical device) within the last 30 days or is currently participating in another trial of an investigational drug or medical device.
3. Subject has other conditions that cause chronic pain at least as severe as the diabetic neuropathy pain, unless subject can clearly distinguish the different types of pain. These cases should be discussed with the medical monitor.
4. Subject is expected to take within 7 days prior to Visit 2 or during the Titration Phase and Maintenance Phase A of the trial AEDs, muscle relaxants, mexiletine, topical analgesics, opioids or unstable doses of tricyclic antidepressants (TCAs). Paracetamol (acetaminophen) up to 2g/day is allowed as rescue medication during the entire trial.
5. Subject is receiving treatment with neurostimulating devices such as spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS). Treatment for pain with acupuncture, surgery, or blockade is not allowed until completion of Maintenance Phase A of the trial.
6. Subject has had an amputation related to diabetes, other than toe amputations.
7. Subject has major skin ulcers.
8. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin levels =2 times the upper limit of normal (ULN) or has alkaline phosphatase levels =3 times the ULN at Visit 1.
9. Subject has impaired renal function, ie, creatinine clearance is lower than 50mL/min at Visit 1. Creatinine clearance (Ccr) will be estimated as follows:
Adult males: Ccr = (140-age) x weight in kg/(72 x serum creatinine in mg/dL)
Adult females: Ccr = ([140-age] x weight in kg/[72 x serum creatinine in mg/dL]) x .85.
10. Subject has other laboratory values, which are outside the normal range at Visit 1 and judged by the investigator as clinically relevant. Exceptions are out-of-range values that are expected in this diabetic population (eg, elevated glucose).
11. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months, or has any cardiac disorder that, in the opinion of the investigator, would put the subject at risk of clinically relevant arrhythmia and/or myocardial infarction.
12. Subject has a QTc =470ms at Visit 1, where QTc is based on a central cardiologist overread.
13. Subject has 2° or 3° AV block or sinus bradycardia (heart rate <50 beats per minute [bpm]) or sinus tachycardia (heart rate >110bpm) at Visit 1, based on a central cardiologist overread.
14. Subject has diastolic blood pressure <50mmHg or >105mmHg, measured in a sitting position after 3 minutes at rest.
15. Subject has a history of alcohol or drug abuse within the last year.
16. Subject has any medical or psychiatric condition that, in the opinion of the investigator, would jeopardize or compromise the subject's ability to participate in this trial or could confound the analysis of efficacy.
17. Subject has known hypersensitivity to any components of the trial medication (or rescue medication) as stated in this protocol.
18. Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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