Post-Herpetic Neuralgia (PHN)Phase 2MOBILENCT02065349
A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain (Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy) and Its Safety
A Phase 2 study testing ASP8477 in people with Post-Herpetic Neuralgia (PHN) and Neuropathic Pain, run by Astellas Pharma Europe B.V. at 17 sites in 4 countries.
Trial summary
The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or postherpetic neuralgia determined by the change in the average daily pain intensity in patients that initially respond favorably to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Herpetic Neuralgia (PHN), Neuropathic Pain, Painful Diabetic Peripheral Neuropathy (PDPN)
- What is being tested?
- ASP8477
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 24 Feb 2014to 13 Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- PDPN subject must have:
- Established diagnosis of diabetes (type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HbA1c) ≤ 11% at Screening.
- Stable glycemic control (HbA1c ≤ 11%) achieved by a drug regimen for at least 3 months prior to Screening.
- At least a 1-year history of DPN pain.
- Diabetic distal symmetrical polyneuropathy symptoms (including pain) stable for at least the last 3 months prior to Screening based on PI judgment and subject-reported medical history.
- PHN subject must have pain present ≥ 6 months after healing of the herpes zoster rash.
Who cannot join
- Subject has significant pain of an etiology other than PDPN or PHN, or clearly non differentiated pain, or plantar fasciitis, heel spurs, tibial neuropathy, Morton's neuroma, bunions, metatarsalgia, arthritis in feet, ischemic pain, neurological disorders unrelated to diabetic neuropathy, skin condition in area of neuropathy that could alter sensation, malignancy, or current orthostatic hypotension, hypo or hypertension, syncope or clinically significant ECG, clinical intolerance to Non-steroidal anti-inflammatory drugs (NSAIDs) or ASP8477, depression, psychosis or psychiatric or neurological illness, BMI of over 35, renal impairment or failure, alcohol (ETOH) or drug abuse, GI complaints.
- Previous investigational therapy within 28 days or 5 half lives
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Czechia6 sites
Site: CZ42003
Choceň, 561 01
Site: CZ42004
Litomyšl, 517 14
Site: CZ42011
Olomouc, 77900
Site: CZ42014
Prague, 12000
Site: CZ42001
Rychnov nad Kněžnou, 516 01
Site: CZ42002
Slezská Ostrava, 710 00
Poland5 sites
Site: PL48003
Bialystok, 15-950
Site: PL48004
Poznan, 60-773
Site: PL48001
Poznan, 61-655
Site: PL48002
Torun, 87-100
Site: PL48005
Warsaw, 00-465
United Kingdom4 sites
Site: GB44001
Glasgow, Scotland, G12OYN
Site: GB44003
Ipswich, IP45PD
Site: GB44006
London, SE17EH
Site: GB44002
Manchester, M320UT
About this study
Official title: A Phase 2a Enriched Enrollment Randomized Withdrawal Study to Assess Analgesic Efficacy and Safety of ASP8477 in Subjects With Peripheral Neuropathic Pain
The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or postherpetic neuralgia determined by the change in the average daily pain intensity in patients that initially respond favorably to treatment with ASP8477.
Read the detailed description
The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.
- Conditions
- Post-Herpetic Neuralgia (PHN), Neuropathic Pain, Painful Diabetic Peripheral Neuropathy (PDPN)
- Being tested
- ASP8477, Placebo
- Keywords
- peripheral neuropathy, PHN, pain, PDPN
- Medical subject headings
- Neuralgia, Postherpetic, Neuralgia, Peripheral Nervous System Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8477Drug
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | oral Receives: Drug: Placebo |
| ASP8477 | Active comparator | oral Receives: Drug: ASP8477 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean of 24-hour average pain intensity, Numeric pain rating scale (NPRS)
Measured: Baseline of the double-blind randomized withdrawal period to the last 3 days of double-blind randomized withdrawal period
Secondary outcomes (5)
Time to treatment failure
Treatment failure is defined as mean 24 hour pain intensity was equal or more than 4 with at least a 30% increase in pain intensity relative to baseline of the double-blind randomized withdrawal period
Measured: Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure
Responder rate to ASP8477 in the Single-Blind Period
Measured: Baseline of the single-blind period (last 3 days of the placebo run-in period) to baseline of the double-blind period (last 3 days of the single-blind period
Patient Global Impression of Change (PGIC) score
Measured: From the baseline of the single-blind period to End of Treatment Visit (Day 49 or upon early discontinuation)
Safety assessed by TEAE and SAE, laboratory tests, vital signs, C-SSRS, PWC and MWC scores, Bond-Lader score
TEAE=Treatment Emergent Adverse Events, SAE = Serious Adverse Event, C-SSRS = Columbia Suicide Severity Rating Scale, PWC = Physician Withdrawal Checklist, MWC = Marijuana Withdrawal Checklist
Measured: From Screening to End of Study Visit (13 weeks)
Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start24 Feb 2014
- Primary completion13 Feb 2015
- Study completion13 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Herpetic Neuralgia (PHN)Studies 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065349
- Sponsor's protocol ID
- 8477-CL-0020
- Other IDs
- 2013-002521-27
- Acronym
- MOBILE
- Status last verified
- Nov 2017
- First submitted
- 13 Feb 2014
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Enriched Enrollment Randomized Withdrawal Study to Assess Analgesic Efficacy and Safety of ASP8477 in Subjects With Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02065349
- Acronym / sponsor ID
- MOBILE / 8477-CL-0020
- Conditions
- Post-Herpetic Neuralgia (PHN), Neuropathic Pain, Painful Diabetic Peripheral Neuropathy (PDPN)
- Keywords
- peripheral neuropathy, PHN, pain, PDPN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2014 (actual)
- Primary completion
- 13 Feb 2015 (actual)
- Study completion
- 13 Feb 2015 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or postherpetic neuralgia determined by the change in the average daily pain intensity in patients that initially respond favorably to treatment with ASP8477.
Detailed description
The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebooral |
| ASP8477 | Active comparator | Drug: ASP8477oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PDPN subject must have:
- PHN subject must have pain present ≥ 6 months after healing of the herpes zoster rash.
Key exclusion criteria (2 listed)
- Subject has significant pain of an etiology other than PDPN or PHN, or clearly non differentiated pain, or plantar fasciitis, heel spurs, tibial neuropathy, Morton's neuroma, bunions, metatarsalgia, arthritis in feet, ischemic pain, neurological disorders unrelated to diabetic neuropathy, skin condition in area of neuropathy that could alter sensation, malignancy, or current orthostatic hypotension, hypo or hypertension, syncope or clinically significant ECG, clinical intolerance to Non-steroidal anti-inflammatory drugs (NSAIDs) or ASP8477, depression, psychosis or psychiatric or neurological illness, BMI of over 35, renal impairment or failure, alcohol (ETOH) or drug abuse, GI complaints.
- Previous investigational therapy within 28 days or 5 half lives
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 |
|---|---|---|
| ASP8477oral | Drug | ASP8477 |
| Placebooral | Drug | Placebo |
Primary outcome
Change in mean of 24-hour average pain intensity, Numeric pain rating scale (NPRS)
Time frame: Baseline of the double-blind randomized withdrawal period to the last 3 days of double-blind randomized withdrawal period
5 secondary outcomes
Time to treatment failure
Time frame: Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure
Responder rate to ASP8477 in the Single-Blind Period
Time frame: Baseline of the single-blind period (last 3 days of the placebo run-in period) to baseline of the double-blind period (last 3 days of the single-blind period
Patient Global Impression of Change (PGIC) score
Time frame: From the baseline of the single-blind period to End of Treatment Visit (Day 49 or upon early discontinuation)
Safety assessed by TEAE and SAE, laboratory tests, vital signs, C-SSRS, PWC and MWC scores, Bond-Lader score
Time frame: From Screening to End of Study Visit (13 weeks)
Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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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 Monitor study director
Astellas Pharma Europe B.V.
17 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 ASP8477 in people with Post-Herpetic Neuralgia (PHN) and Neuropathic Pain, run by Astellas Pharma Europe B.V. at 17 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 6 inclusion and 2 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Czechia, Poland, United Kingdom, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in mean of 24-hour average pain intensity, Numeric pain rating scale (NPRS) (time frame: Baseline of the double-blind randomized withdrawal period to the last 3 days of double-blind randomized withdrawal period). 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 8 Nov 2017.