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

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ClinicalTrials.gov Identifier: NCT00861042
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : September 22, 2014
Sponsor:
Information provided by:
UCB Pharma

Tracking Information
First Submitted Date  ICMJE March 12, 2009
First Posted Date  ICMJE March 13, 2009
Last Update Posted Date September 22, 2014
Study Start Date  ICMJE April 2002
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
  • 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 ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
  • 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 ]
  • 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 ]
  • 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 ]
  • Time to exit (days) de to lack of efficacy of treatment [ Time Frame: Daily assessment during entire trial participation including assessments at site visits ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Quality of life assessments during specific site visits [ Time Frame: Daily assessment during entire trial participation including assessments at site visits ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
Official Title  ICMJE An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
Brief Summary The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Painful Diabetic Neuropathy
Intervention  ICMJE Drug: SPM927/Lacosamide
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 Name: SPM927 / Lacosamide / Vimpat®
Study Arms  ICMJE Experimental: 1
Intervention: Drug: SPM927/Lacosamide
Publications * Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2009)
69
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00861042
Other Study ID Numbers  ICMJE SP0665
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, UCB
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date July 2010

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