Neuralgia, PostherpeticPhase 2NCT01129531
A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
A Phase 2 study testing AGN-214868 in people with Neuralgia, Postherpetic, run by Allergan at 4 sites in 4 countries.
Trial summary
This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuralgia, Postherpetic
- What is being tested?
- AGN-214868
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jun 2010to Jan 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash
Who cannot join
- Female patients with reproductive potential
- Active herpes zoster skin rash
- Current or anticipated treatment with acupuncture, TNS, or steroids
- Current or anticipated use of topical analgesic agents with PHN
- Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.
- Conditions
- Neuralgia, Postherpetic
- Being tested
- AGN-214868, Placebo to AGN-214868
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-214868Drug
AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.
Placebo to AGN-214868Drug
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
| Study group | Role | What they receive |
|---|---|---|
| AGN-214868 3.25 μg | Experimental | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment. Receives: Drug: AGN-214868 |
| AGN-214868 16.25 μg | Experimental | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment. Receives: Drug: AGN-214868 |
| Placebo | Placebo comparator | Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. Receives: Drug: Placebo to AGN-214868 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Average Pain Intensity Score at Week 12
Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12
Secondary outcomes (3)
Change From Baseline in Area of Spontaneous Pain
A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12
Change From Baseline in Area of Allodynia
A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12
Change From Baseline in Evoked Pain Score in the Area of Allodynia
Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuralgia, PostherpeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129531
- Sponsor's protocol ID
- 214868-002
- Status last verified
- Sep 2013
- First submitted
- 21 May 2010
- Last updated
- 15 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT01129531
- Acronym / sponsor ID
- 214868-002
- Conditions
- Neuralgia, Postherpetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Posted 15 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AGN-214868 3.25 μg | Experimental | Drug: AGN-214868AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment. |
| AGN-214868 16.25 μg | Experimental | Drug: AGN-214868AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment. |
| Placebo | Placebo comparator | Drug: Placebo to AGN-214868Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash
Key exclusion criteria (5 listed)
- Female patients with reproductive potential
- Active herpes zoster skin rash
- Current or anticipated treatment with acupuncture, TNS, or steroids
- Current or anticipated use of topical analgesic agents with PHN
- Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN-214868AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment. | Drug | AGN-214868 16.25 μg, AGN-214868 3.25 μg |
| Placebo to AGN-214868Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. | Drug | Placebo |
Primary outcome
Change From Baseline in the Average Pain Intensity Score at Week 12
Time frame: Baseline, Week 12
Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.
3 secondary outcomes
Change From Baseline in Area of Spontaneous Pain
Time frame: Baseline, Week 12
Change From Baseline in Area of Allodynia
Time frame: Baseline, Week 12
Change From Baseline in Evoked Pain Score in the Area of Allodynia
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGN-214868 in people with Neuralgia, Postherpetic, run by Allergan at 4 sites in 4 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 1 inclusion and 5 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 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Czechia, Germany, Poland. 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 15 Nov 2013). 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?
Change From Baseline in the Average Pain Intensity Score at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2013.