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

Painful Diabetic Neuropathy Clinical Trial

Official title:

A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861445
• Other study ID #: SP0614
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2009
• Last updated: October 17, 2014
• Start date: June 2001
• Est. completion date: February 2003

Study information

• Verified date: July 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: February 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy

Intervention

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

Other:
• Placebo
Placebo tablets two times a day for 10 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)		Daily assessment during entire trial participation including visits at the site	Yes
Secondary	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	Yes