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Completed

NCT Number: NCT00861042

An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy

The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.

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Key information

Conditions

Painful Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has successfully completed a previous trial with SPM 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of SPM 927.
  • Subject has stable, good or fair diabetic control (HbA1c ≤10% ).

Exclusion criteria

  • Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain, i.e. peripheral arterio-vascular disease.
  • Subject receives treatment for seizures.
  • Subject has had an amputation related to diabetes, other than toe amputation.
  • Subject has major skin ulcers.
  • Subject has clinically significant ECG abnormalities.
  • Subject expects to take during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, skeletal muscle relaxants, benzodiazepines or over-the-counter medications with centrally acting properties.
  • Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
  • Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin, or GGT) ≥ 2x ULN at Visit 1.
  • At Visit 1, subject has impaired renal function, i.e., creatinine clearance (ClCr) is lower than 60 mL/min.

Treatment and study plan

SPM927/Lacosamide

Drug

SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation

Other names: SPM927 / Lacosamide / Vimpat®

Primary outcomes

  1. Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy

    Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits

  2. Adverse events reported spontaneously by the subject or observed by the investigator

    Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.

  3. Changes laboratory, ECG and vital signs parameters.

    Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.

  4. Changes in physical or neurological examination findings

    Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.

  5. Subject withdrawal due to adverse events

    Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.

Secondary outcomes

  1. The secondary objective is to gather further information on the efficacy of SPM 927 in this indication.

    Time frame: Daily assessment during entire trial participation including assessments at site visits

  2. Within-subject change in average pain score: Daily assessments throughout the trial

    Time frame: Daily assessment during entire trial participation including assessments at site visits

  3. Change in subject's perception of different neuropathic pain qualities during specific site visit

    Time frame: Daily assessment during entire trial participation including assessments at site visits

  4. Time to exit (days) de to lack of efficacy of treatment

    Time frame: Daily assessment during entire trial participation including assessments at site visits

  5. Change in subject's perception of sleep and activity throughout the trial, daily assessments

    Time frame: Daily assessment during entire trial participation including assessments at site visits

  6. Patient's Global Impression of Change in Pain (PGIC) during specific site visit

    Time frame: Daily assessment during entire trial participation including assessments at site visits

  7. Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit

    Time frame: Daily assessment during entire trial participation including assessments at site visits

  8. Quality of life assessments during specific site visits

    Time frame: Daily assessment during entire trial participation including assessments at site visits

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Important dates

Study start
2002
Primary completion
2004
Study completion
2005
First posted
Mar 13, 2009
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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