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CompletedNCT00861445Updated Oct 20, 2014

A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

A Phase 2 interventional study of SPM927/Lacosamide and Placebo in Painful Diabetic Neuropathy, sponsored by UCB Pharma. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-20.

Sponsored by UCB Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy

02

Conditions studied

  • Painful Diabetic Neuropathy

Keywords

  • Lacosamide, Vimpat®
03

In context

Diabetic Neuropathies

617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.

This study's enrollment of 119 is above the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.

Browse Diabetic Neuropathies studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).
  • Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
  • subjects must have good or fair diabetic control (Hgb A1c \< 10%)

Exclusion criteria

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 any amputations other than diabetically-related toe amputations.
  • Subject has major skin ulcers.
  • Subject has clinically significant ECG abnormalities.
  • Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and 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.
  • At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal.
  • subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
119 participants (actual)

Study arms

  • Experimental
    1

    Drug: SPM927/Lacosamide

  • Placebo comparator
    2

    Other: Placebo

Interventions

  • DrugSPM927/Lacosamide

    SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks

  • OtherPlacebo

    Placebo tablets two times a day for 10 weeks

    Also known as: SPM927, Lacosamide, Vimpat®

06

What researchers measure

Primary outcomes

  1. The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy

    Time frame: Assessments throughout the trial, either daily and/or at clinic visits

Secondary outcomes

  1. Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation)

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

  2. Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation)

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

  3. Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)

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

  4. Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Rauck RL, Shaibani A, Biton V, Simpson J, Koch B. Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. Clin J Pain. 2007 Feb;23(2):150-8. doi: 10.1097/01.ajp.0000210957.39621.b2. PubMed 17237664 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00861445
Lead sponsor
UCB Pharma
First posted
Mar 13, 2009
Start date
Jun 2001
Primary completion
Jan 2003
Completion
Feb 2003
Last update
Oct 20, 2014

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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