A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

NCT00861445 | Completed Phase 2 DMC

• 1 other identifier: SP0614
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Painful Diabetic Neuropathy

Keywords

Lacosamide, Vimpat®

Outcome Measures

Primary Outcomes (1)

• The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy

  Assessments throughout the trial, either daily and/or at clinic visits

Secondary Outcomes (4)

• Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation)

  Daily assessment during entire trial participation including visits at the site

• Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation)

  Daily assessment during entire trial participation including visits at the site

• Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)

  Daily assessment during entire trial participation including visits at the site

• Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)

  Daily assessment during entire trial participation including visits at the site

Study Arms (2)

1

EXPERIMENTAL

Drug: SPM927/Lacosamide

2

PLACEBO COMPARATOR

Other: Placebo

Interventions

SPM927/Lacosamide DRUG

SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks

1

Placebo OTHER

Placebo tablets two times a day for 10 weeks

Also known as: SPM927, Lacosamide, Vimpat®

2

Eligibility Criteria

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

You may qualify if:

• 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%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Pharma: lead

Related Publications (1)

• Rauck RL, Shaibani A, Biton V, Simpson J, Koch B. Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. Clin J Pain. 2007 Feb;23(2):150-8. doi: 10.1097/01.ajp.0000210957.39621.b2.

  PMID: 17237664 RESULT

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

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

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

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: June 1, 2001
• Primary Completion: January 1, 2003
• Study Completion: February 1, 2003
• Last Updated: October 20, 2014

Record last verified: 2010-07