A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00861445

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 II

MedlinePlus related topics: Diabetic Nerve Problems

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

Further study details as provided by UCB:

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
1: Experimental	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
2: Placebo Comparator	Other: Placebo Placebo tablets two times a day for 10 weeks

Eligibility

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

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

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

Keywords provided by UCB:

Lacosamide, Vimpat®

Study placed in the following topic categories:

Signs and Symptoms
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Neurologic Manifestations
Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Signs and Symptoms
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Nervous System Diseases

Diabetes Mellitus
Neurologic Manifestations
Endocrine System Diseases
Pain
Diabetes Complications

ClinicalTrials.gov processed this record on May 07, 2009