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Neuralgia, PostherpeticPhase 2NCT00160667

A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)

A Phase 2 study testing Brivaracetam in people with Neuralgia, Postherpetic, run by UCB Pharma at 50 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuralgia, Postherpetic
What is being tested?
Brivaracetam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
50 sitesin 10 countries
Study dates
11 Oct 2004to 5 Jan 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 post-herpetic neuralgia (PHN) or who receives trans-electrical neural stimulation (TENS.
  • Tricyclic antidepressants (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 Tricyclic antidepressants (TCAs), non-steroidal anti-inflammatory drugs (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.

Trial locations and contacts

50 sites in 10 countries.

50 sites in 10 countries

Poland11 sites

  • Study site

    Gdansk

  • Study site

    Grudziądz

  • Study site

    Katowice

  • Study site

    Kielce

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Olsztyn

  • Study site

    Poznan

  • Study site

    Warsaw

  • Study site

    Wroclaw

  • Study site

    Zgierz

Other trials in Poland

Spain6 sites

  • Study site

    Cadiz

  • Study site

    Granada

  • Study site

    Hospitalet de Llobregat (Barcelona)

  • Study site

    Madrid

  • Study site

    Sant Cugat Del Valles (Barcelona)

  • Study site

    Valencia

Other trials in Spain

Belgium5 sites

  • Study site

    Brussels

  • Study site

    Eeklo

  • Study site

    Genk

  • Study site

    Liège

  • Study site

    Lubbeek (Pellenberg)

Other trials in Belgium

France5 sites

  • Study site

    Annecy

  • Study site

    Clermont-Ferrand

  • Study site

    Nice

  • Study site

    Toulouse

  • Study site

    Voiron

Other trials in France

Germany5 sites

  • Study site

    Bad Wörishofen

  • Study site

    Bochum

  • Study site

    Essen

  • Study site

    Kassel

  • Study site

    Rodgau

Other trials in Germany

Czechia4 sites

  • Study site

    Hradec Králové

  • Study site

    Prague

  • Study site

    Svitavy

  • Study site

    Ústí nad Labem

Other trials in Czechia

Slovakia4 sites

  • Study site

    Bratislava

  • Study site

    Dubnica nad Váhom

  • Study site

    Košice

  • Study site

    Nitra

Other trials in Slovakia

United Kingdom4 sites

  • Study site

    Bath

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Winchester

Other trials in United Kingdom

Bulgaria3 sites

  • Study site

    Pleven

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Serbia3 sites

  • Study site

    Belgarde

  • Study site

    Belgrade

  • Study site

    Kragujevac

Other trials in Serbia

About this study

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)

Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.

Being tested
Placebo, Brivaracetam
Keywords
Post-herpetic Neuralgia (PHN), Brivaracetam
Medical subject headings
Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Daily oral dose of two equal intakes.

  • BrivaracetamDrug

    Also called Briviact

    Daily oral dose of two equal intakes.

Study groups in NCT00160667
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching placebo tablets administered twice a day.
Receives: Drug: Placebo
Brivaracetam 200 mg/dayExperimentalBrivaracetam 200 mg/day (100 mg administered twice a day).
Receives: Drug: Brivaracetam
Brivaracetam 400 mg/dayExperimentalBrivaracetam 400 mg/day (200 mg administered twice a day).
Receives: Drug: Brivaracetam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period

    Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain.

    A negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline.

    Measured: Baseline, last week of the 4-week Treatment Period

Secondary outcomes (13)

  1. Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period

    A responder is defined as a subject with a >= 30 % reduction in average pain intensity score at the Evaluation Week (last week of the Treatment Period) compared to the Baseline Period.

    Measured: Baseline, last week of the 4-week Treatment Period

  2. Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score

    Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain.

    A negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline.

    Measured: Baseline, each Evaluation visit (up to Week 4)

  3. Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score

    Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'.

    A negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline.

    Measured: Baseline, last assessment during the 4-week Treatment Period

  4. Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score

    Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'.

    A negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline.

    Measured: Baseline, each Evaluation visit (up to Week 4)

  5. Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Total Pain Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)

    The SF-MPQ has three components: the first one consists of 15 subscales (descriptors: 11 sensory, 4 affective) which are rated on an intensity scale with 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total subscales (descriptors). The SF-MPQ also includes a Present Pain Intensity (PPI) index and a visual analogue scale (VAS). Each of the 15 subscales is rated from 0=none to 3=severe pain. The Total Pain Score of the SF-MPQ is the sum of all 15 ratings and can hence vary from 0 (15*0=0: no pain) to 60 (15*4=60: severe pain). The mean change in total score is reported.

    Measured: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  6. Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Sensory Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)

    The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

    The sensory score ranges from 0 to 33. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean.

    A negative value in absolute change indicates an improvement.

    Measured: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  7. Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Affective Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)

    The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

    The affective score ranges from 0 to 12. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean.

    A negative value in absolute change indicates an improvement.

    Measured: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  8. Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ

    Present pain intensity (PPI) was rated by the subject. The score ranges from 0 (no pain) to 5 (excruciating). A negative value in absolute change indicates an improvement in PPI.

    Measured: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  9. Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ

    Pain burden was rated by the subject using the visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst possible pain). A negative value in absolute change indicates an improvement in pain burden.

    Measured: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  10. Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit

    Patient´s global assessment of change in pain was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).

    Measured: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  11. Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit

    Investigator´s global assessment of change was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).

    Measured: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  12. Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient

    Brush-evoked allodynia intensity was assessed by the subject on an 11-point numerical rating scale, ranging from 0= no pain to 10= unbearable Pain.

    A negative value in percent change indicates an improvement in brush-evoked allodynia intensity.

    Measured: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  13. Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator

    Allodynia is pain due to a normally non-painful stimulus. The brush-evoked allodynia areas were assessed by the Investigator (location and contour of the allodynic regions drawn on a standard dermatomal map). Areas (mm²) of the allodynic regions drawn by the Investigator were afterwards computed by means of appropriate tools and calibrated templates. The larger the area in square centimeters the more allodynia. A negative value in percent change in the brush-evoked allodynia area indicates improvement.

    Measured: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study start11 Oct 2004
  3. Primary completion5 Jan 2006
  4. Study completion5 Jan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00160667
Sponsor's protocol ID
N01162
Other IDs
2004-000975-32, 2004
Status last verified
Aug 2018
First submitted
8 Sep 2005
Last updated
31 Jan 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brivaracetam in people with Neuralgia, Postherpetic, run by UCB Pharma at 50 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Poland, Spain, Belgium, France, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period (time frame: Baseline, last week of the 4-week Treatment Period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00160667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.

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