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

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00861042
First received: March 12, 2009
Last updated: July 14, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Painful Diabetic Neuropathy
Drug: SPM927/Lacosamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to exit (days) de to lack of efficacy of treatment [ Time Frame: Daily assessment during entire trial participation including assessments at site visits ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of life assessments during specific site visits [ Time Frame: Daily assessment during entire trial participation including assessments at site visits ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: April 2002
Study Completion Date: March 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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®

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861042

Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Publications:
Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00861042     History of Changes
Other Study ID Numbers: SP665
Study First Received: March 12, 2009
Last Updated: July 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Lacosamide, Vimpat®

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014