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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00861445
First received: March 12, 2009
Last updated: July 14, 2010
Last verified: July 2010
History of Changes

March 12, 2009
July 14, 2010
June 2001
January 2003   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00861445 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Painful Diabetic Neuropathy
  • Drug: SPM927/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
  • Other: Placebo
    Placebo tablets two times a day for 10 weeks
    Other Names:
    • SPM927
    • Lacosamide
    • Vimpat®
  • Experimental: 1
    Intervention: Drug: SPM927/Lacosamide
  • Placebo Comparator: 2
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
February 2003
January 2003   (final data collection date for primary outcome measure)

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:

  • 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00861445
SP614
Yes
Study Director, UCB
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP