Efficacy & Safety Study of Nonracemic Methadone for the Relief of Chronic Peripheral Neuropathic Pain

NCT01429181 | Completed Phase 2

• 1 other identifier: MP10-001
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change in average daily pain scores

  From Baseline to Week 4

Study Arms (2)

Non Racemic Methadone

EXPERIMENTAL

Non-Racemic Methadone Hydrochloride 5 mg Capsules containing a non-racemic mixture of methadone isomers.

Drug: Non-racemic mixture of methadone HCl

Placebo

PLACEBO COMPARATOR

Matching placebo capsules

Drug: Non-racemic mixture of methadone HCl

Interventions

Non-racemic mixture of methadone HCl DRUG

Non-racemic mixture of methadone HCl capsules, 5 mg

Non Racemic Methadone; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Hypotension: sitting or standing systolic blood pressure \<= 90 mmHg and/or diastolic blood pressure \<= 60 mmHg at screening and/or orthostatic hypotension (defined as a difference between sitting and standing systolic blood pressure \>20 mmHg and/or a difference between sitting and standing diastolic blood pressure \>10 mmHg)
• Any clinically important ECG abnormality (including QT interval exceeding 450 ms)
• Recent history (within the last 12 months) of risk factors for development of prolonged QT interval, including cardiac hypertrophy, concomitant diuretic use, hypocalcemia, hypomagnesemia

Sponsors & Collaborators

• MetaPharm, Inc.: lead

Study Officials

• Eugene Mironer, MD

  MetaPharm, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 5, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 30, 2017

Record last verified: 2017-03