Efficacy & Safety Study of Nonracemic Methadone for the Relief of Chronic Peripheral Neuropathic Pain
CompletedPhase 2NCT01429181
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
There is a growing evidence that the d-isomer of methadone is effective in treating neuropathic pain while the l-isomer of methadone is the only effective isomer of methadone for treating somatic pain. This study will examine a combination of different amounts of the d- and l-isomers of methadone specifically tailored to the chronic peripheral neuropathic pain. Non-racemic mixture of methadone isomers will be tested in this pilot efficacy and safety study. This study will evaluate effect of the three doses of the non-racemic mixture of methadone hydrochloride patients with chronic peripheral neuropathic pain compared with a placebo. The study will also examine the minimally effective and maximally tolerated doses of the non-racemic mixture of methadone. Finally, the safety and tolerability of the non-racemic methadone therapy will be evaluated.
Study details
- Official title
- Pilot Study to Evaluate Efficacy, Tolerability and Safety Nonracemic Methadone HCl in Patients With Chronic Peripheral Neuropathic Pain: Double-Blind, Placebo-Controlled, Crossover Study Followed by Open-Label, Single-Arm Extension
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Interventions
- Drug: Non-racemic mixture of methadone HCl
- Sponsor
- MetaPharm, Inc.
- Start date
- 2012-01
- Primary completion
- 2014-09
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male or female 18 years of age or older; * Female with a negative serum βhCG pregnancy test * Female of non-childbearing potential (postmenopausal or surgically sterile) OR female of child-bearing potential agreed to use the protocol-approved contraceptive method * Documented diagnosis of neuropathic pain associated with diabetic peripheral neuropathy for at least 6 months * Average daily pain severity score \>=4 for the seven days prior to randomization (based on an 11-point numerical rating scale where 0= no pain and 10=worst possible pain) * Score \>= 40 mm on the VAS of the Short Form McGill Pain Questionnaire (SF-MPQ) at screening and randomization visits * Stable doses (for at least three weeks) of non-opioid analgesics including NSAIDS, corticosteroids, gabapentin, pregabalin or antidepressants prescribed for the purposes of pain control or pain treatment naïve * Willing to refrain from any pain-relieving drugs other than the protocol-approved rescue medications (acetaminophen, \<= 3 g daily or aspirin \<= 325 mg daily) during the screening phase and the course of the study * Willing to limit alcohol consumption during the study according to protocol requirements * Able to understand and complete study diary and questionnaires * Willing to give informed consent prior to entry into the study Exclusion Criteria: * A documented neuropathy of any cause other than diabetic peripheral neuropathy * A severe intermittent pain for reasons other than radiculopathy (e.g., migraine attacks) * History of head injury and/or increased intracranial pressure * Any neurologic disorder unrelated to diabetic peripheral neuropathy * Non-adequate renal and/or hepatic function as follows: Serum creatinine \> 1.5 x ULN (upper limit of normal range) Liver enzymes (ALT and AST) \> 2 x ULN * Any other know laboratory abnormality that, in the investigator's opinion, would contraindicate study participation * Chronic hepatitis B, hepatitis C, or HIV infection * Abnormal cognition defined as obvious clinical findings of state of arousal, confusion and memory or concentration deficit. * Recent history (within the previous 12 months) of respiratory depression, acute bronchial asthma or hypercarbia, or any other severe pulmonary or respiratory disease * Recent history (within the previous 12 months) of sleep apnea * Any hemostatic disorders or a current treatment with anticoagulants; * Unstable cardiovascular disease or symptomatic peripheral vascular disease …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01429181