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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).

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00861068
First received: March 12, 2009
Last updated: October 17, 2014
Last verified: March 2009
  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 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 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).

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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
Experimental: 1 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
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00861068     History of Changes
Other Study ID Numbers: SP0655
Study First Received: March 12, 2009
Last Updated: October 17, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Department of Health

Keywords provided by UCB Pharma:
Lacosamide, Vimpat®

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014