A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

NCT00235443 | Completed Phase 2 Results

• 1 other identifier: SP0745
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 84

Brief Summary

Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.

Conditions

Diabetic Neuropathy

Keywords

Painful Distal Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.

  Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).

  Throughout the study up to a maximum study period of 2.8 years

Secondary Outcomes (17)

• Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).

  Baseline to end of entire treatment phase (maximum study period of 2.8 years).

• Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).

  Baseline to end of entire treatment phase (maximum study period of 2.8 years).

• Patient's Global Impression of Change (PGIC) From Baseline in Pain.

  Baseline to Termination Visit

• Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.

  Baseline to Termination Visit

• Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness

  Baseline to Termination Visit

Study Arms (1)

1

EXPERIMENTAL

Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day

Drug: lacosamide

Interventions

lacosamide DRUG

Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.

Also known as: SPM927

1

Eligibility Criteria

• Age: 32 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.

You may not qualify if:

• Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval \>=500 milliseconds (ms), and/or a QTc interval increase of \>=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.
• Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>=3 times the upper limit of the normal range (ULN) with total bilirubin \>=2 times ULN or transaminases (AST and/or ALT) \>=5 times ULN.
• Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (84)

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Anniston, Alabama, United States

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Hoover, Alabama, United States

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Huntsville, Alabama, United States

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Northport, Alabama, United States

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Tuscaloosa, Alabama, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Irvine, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Spring Valley, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Stratford, Connecticut, United States

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Newark, Delaware, United States

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Wilmington, Delaware, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Fort Myers, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Pembroke Pines, Florida, United States

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Pinellas Park, Florida, United States

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South Miami, Florida, United States

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St. Petersburg, Florida, United States

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Sunrise, Florida, United States

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Tallahassee, Florida, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Elk Grove Village, Illinois, United States

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North Chicago, Illinois, United States

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Evansville, Indiana, United States

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West Des Moines, Iowa, United States

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Crestview Hills, Kentucky, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Paducah, Kentucky, United States

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Owings Mills, Maryland, United States

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Towson, Maryland, United States

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Brockton, Massachusetts, United States

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Ann Arbor, Michigan, United States

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St Louis, Missouri, United States

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Great Falls, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Lawrenceville, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Albany, New York, United States

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Mineola, New York, United States

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White Plains, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Upland, Pennsylvania, United States

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Greer, South Carolina, United States

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Bristol, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Richardson, Texas, United States

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San Antonio, Texas, United States

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Bennington, Vermont, United States

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Richmond, Virginia, United States

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Salem, Virginia, United States

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Virginia Beach, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Wenatchee, Washington, United States

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Related Publications (1)

• 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.

  PMID: 18619874 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Lacosamide; 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB Pharma

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: September 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 17, 2018
• Results First Posted: October 5, 2009

Record last verified: 2017-07

Locations

US (84)