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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
  Purpose

The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

Resource links provided by NLM:

Drug Information available for: Lacosamide
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 119
Study Start Date: June 2001
Study Completion Date: February 2003
Primary Completion Date: January 2003 (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 400mg/day, intake in the morning and in the evening, intake for 10 weeks
Placebo Comparator: 2 Other: Placebo
Placebo tablets two times a day for 10 weeks
Other Names:
  • SPM927
  • Lacosamide
  • Vimpat®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861445

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

Publications:

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00861445     History of Changes
Other Study ID Numbers: SP614
Study First Received: March 12, 2009
Last Updated: July 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Lacosamide, Vimpat®

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 19, 2013