A Study Assessing Brivaracetam in Subjects With Persistent Pain After Shingles (Post-Herpetic Neuralgia) - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00160667

Purpose

Study assessing efficacy, safety and tolerability of brivaracetam in PHN. Duration will be of 7 weeks divided into 3 periods with no up-titration, nor down-titration. Patients will be asked to complete a Diary book containing pain and sleep-interference scales on a daily basis.

Condition	Intervention	Phase
Nerve Pain	Drug: Brivaracetam (ucb 34714)	Phase II

MedlinePlus related topics: Shingles

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	An Exploratory, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study, for the Assessment of Efficacy, Safety and Tolerability of Ucb 34714 50 mg Oral Capsules in b.i.d. Administration at the Doses of 200 mg/Day and 400 mg/Day, in Subjects (at Least 18 Years Old) Suffering From Post-Herpetic Neuralgia (PHN)

Further study details as provided by UCB:

Primary Outcome Measures:

To evaluate the reduction in the average pain intensity score on an 11-point numerical pain rating scale from the Baseline Period to the last week of the Treatment Period (4 weeks).

Secondary Outcome Measures:

o Change in the Sleep Interference Score (11-point numerical sleep interference rating scale from the Baseline Period to the last week of the Treatment Period (4 weeks).
o Absolute change from the Randomization visit to the Evaluation/Early Discontinuation visit, in each score of the SF-MPQ.
o Reduction in the brush-evoked allodynia intensity and area from the Randomization Visit to the Evaluation/Early Discontinuation visit (4 weeks).
o Safety and tolerability of Brivaracetam in PHN.

Estimated Enrollment:	150
Study Start Date:	October 2004
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male/female subject aged 18 years or older.
Pain present for at least 6 months after healing of the acute herpes zoster skin rash.
Pain intensity score assessed on an 11-point numerical pain rating scale with a score of at least 4 at the screening visit and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period.

Exclusion Criteria:

Subject getting any kind of psychological support to help cope with pain such as biofeedback or behavioral cognitive therapy.
Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for PHN or who receives TENS (trans-electrical neural stimulation).
TCAs or non-steroidal anti-inflammatory drug (NSAIDs) or permitted opioid analgesics ("strong" opioids are forbidden) that started less than 30 days and/or are not stabilized prior to screening and/or are not expected to be kept stable during the study.
Intake of more than two pain treatments at trial entry (screening visit) including TCAs, NSAIDs or permitted opioid analgesics.
Subject being treated with Carbamazepine for any indication.
Known coexistent source of painful peripheral neuropathy or other systemic disease associated with a secondary painful neuropathy.
Subject being treated in the four weeks prior to screening visit with "strong" opioid analgesics.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160667

Show 50 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

Philipp von Rosenstiel, MD

Unaffiliated

More Information

Study ID Numbers:	N01162, EudraCT 2004-000975-32
Study First Received:	September 8, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00160667
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Bulgaria: Bulgarian Drug Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Spain: Ministry of Health and Consumption; Slovakia: State Institute for Drug Control; Czech Republic: State Institute for Drug Control; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB:

Post-herpetic Neuralgia (PHN)
Brivaracetam

Study placed in the following topic categories:

Neuralgia, Postherpetic
Herpes Zoster
Signs and Symptoms
Neuromuscular Diseases

Neuralgia
Peripheral Nervous System Diseases
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009