A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN). - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00861068

Purpose

The objective of the trial is to investigate the analgesic efficacy of SPM 927 in subjects with moderate to severe neuropathic pain due to Postherpetic Neuralgia (PHN)

Condition	Intervention	Phase
Postherpetic Neuralgia	Drug: SPM927/Lacosamide Other: Placebo	Phase II

MedlinePlus related topics: Shingles

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).

Further study details as provided by UCB:

Primary Outcome Measures:

Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase [ Time Frame: Daily Assessments via patient diary and during patient's visit at the site ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Different qualities of pain due to PHN, 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 ]
Investigate the tolerability and safety of SPM927 (assessments and reporting during entire trial participation). [ Time Frame: Daily assessment during entire trial participation including visits at the site ] [ Designated as safety issue: Yes ]
To 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:	44
Study Start Date:	February 2002
Study Completion Date:	January 2003
Primary Completion Date:	December 2002 (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 up to 600mg/day, intake in the morning and in the evening, intake for 11 weeks
2: Placebo Comparator	Other: Placebo Placebo tablets two times a day for 10 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has clinically diagnosed painful postherpetic neuralgia present at least six months after healing of a herpes zoster skin rash and has at least one form of allodynia
Subject must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).

Exclusion Criteria:

Subject has other conditions that cause pain at least as severe as the postherpetic neuralgia.
Subject has had any surgical treatment or any neurolytic injections for PHN
Subject has clinically significant ECG and laboratory abnormalities.
Subject is receiving treatment with anti-epileptic drugs (AEDs), muscle relaxants, mexiletine, topical analgesics, antidepressants, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, benzodiazepines, and antiviral agents.
Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin and GGT out of the reference range) > 1,5 x ULN (upper limit of normal) at visit 1
Subject has serum creatinine ≥ 2 times the upper limit of reference range at Visit 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861068

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:	SP655
Study First Received:	March 12, 2009
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00861068 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Department of Health

Keywords provided by UCB:

Lacosamide, Vimpat®

Study placed in the following topic categories:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on May 07, 2009