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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

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2002
Actual Primary Completion Date : December 2004
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Lacosamide

Arm Intervention/treatment
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®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861042


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

Publications of Results:
Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00861042     History of Changes
Other Study ID Numbers: SP0665
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: July 2010

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