Diabetic NeuropathyPhase 2/3NCT00505284
An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy
A Phase 2/3 study testing E2007 (2 mg), E2007 (4 mg) and E2007 (6 mg) in people with Diabetic Neuropathy, run by Eisai Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- E2007 (2 mg), E2007 (4 mg) and E2007 (6 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2008
- Phase
- Phase 2/3
- 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
- To be included, patients must meet all of the following:
- Provide written informed consent, prior to entering the study or undergoing any study procedures
- Male and female patients ≥18 years of age will be eligible for enrollment. Females should be either not of childbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or intrauterine device [IUD]) for at least 1 month before Screening (Visit 1) and for 1 month after the end of the study (Visit 8). They must also have a negative serum beta-human chorionic gonadotropin (ß-hCG) at Screening (Visit 1). Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) starting with the Baseline Phase and continuing throughout the study period.
- Have Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration
- Have pain that has been stable over the past 6 months and, in the opinion of the investigator, not in an identifiably improving or worsening trend
- Have hemoglobin A1c ≤ 11%
Show all 16Show fewer
- Score of ≥ 40 mm on the visual analog scale (VAS) of the short form McGill Pain Questionnaire (SF-MPQ) at both Screening (Visit 1) and Baseline (Visit 2 prior to randomization)
- Have completed the patient diary for at least 6 of the 7 days prior to Baseline (Visit 2)
- Have average daily pain score of ≥ 4, on 11-point Likert-type numeric rating scale during the 7 days prior to Baseline (to be obtained from the patient diary)
- Be reliable, willing, and able to cooperate with all study procedures including the following:
- accurately fill out the diary on a daily basis
- return for study visits on the required dates
- accurately and reliably report symptoms (including treatment-emergent signs and symptoms)
- take study drug as required by protocol
- Be on stable antidiabetic treatment (insulin, oral agents, or lifestyle) that is not anticipated to change during the course of the study, except if medically required
- Be on stable analgesic treatment (same medication and dose) or stable nonpharmacological pain treatment for at least 4 weeks prior to Screening (Visit 1) and remain on this stable treatment throughout the study (unless otherwise directed by a physician). Nonpharmacologic pain treatment includes the following: relaxation/hypnosis, physical or occupational therapy, counseling, etc. Episodic or periodic treatments such as monthly injections for treatment of pain (e.g., local anesthetics) will not be permitted.
Who cannot join
- Patients with any one of the following will be excluded.
- Patients with any condition that could interfere with the conduct of the study or confound efficacy evaluations including the following:
- Pain or neuropathy from another cause (including central pain, radiculopathy, painful arthritis, etc.)
- Skin or soft-tissue lesions in the area affected by neuropathy that are painful or could alter sensation
- Amputation, other than toes
- Patients motivated by secondary gain, or where there is a negative-incentive to achieving pain and functional pain relief (eg, litigation). This will be determined by the patient's medical history.
Show all 20Show fewer
- Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, CNS, psychiatric, endocrine (other than diabetes), or immunologic, including patients with any of the following broad disease categories:
- Systemic infections (e.g., human immunodeficiency virus [HIV], hepatitis, tuberculosis [TB], syphilis)
- History of past (within the past 12 months) or present drug or alcohol abuse as per the Diagnostic and Statistical Manual - 4th Edition (DSM IV) criteria
- History of acute coronary syndrome within the past 12 months
- Active cancer within the previous 5 years
- Systemic chemotherapy or immunotherapy within the past 5 years
- History of major depression, bipolar disease, psychosis or suicidal ideation or attempts within the past 5 years
- Patients with any of the following laboratory abnormalities at Screening (Visit 1) or Baseline (Visit 2):
- Clinically significant electrocardiogram (ECG) abnormality, including prolonged QTc (defined as QTc ≥ 450 msec)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN)
- White blood cell (WBC) count ≤ 2500/μL, absolute neutrophil count ≤ 1000/μL, platelet count < 100,000
- Positive urine drug screen for drugs of abuse, except those prescribed by a properly licensed practitioner (e.g., opioids such as codeine for neuropathic pain)
- Other clinically significant laboratory values
- Exposure to an investigational drug (including E2007) within the 30 days prior to Screening (Visit 1) or any prior exposure to E2007.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy
The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes.
- Conditions
- Diabetic Neuropathy
- Being tested
- Placebo, E2007 (2 mg), E2007 (4 mg), E2007 (6 mg), E2007 (8 mg)
- Keywords
- Diabetic neuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo tablets, once daily, for 15 weeks (taken orally).
E2007 (2 mg)Drug
Also called Perampanel
Perampanel, 2 mg once daily, for 15 weeks (taken orally).
E2007 (4 mg)Drug
Also called Perampanel
Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally).
E2007 (6 mg)Drug
Also called Perampanel
Perampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally).
E2007 (8 mg)Drug
Also called Perampanel
Perampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Perampanel 2mg | Active comparator | Not described Receives: Drug: E2007 (2 mg) |
| Perampanel 4mg | Active comparator | Not described Receives: Drug: E2007 (4 mg) |
| Perampanel 6mg | Active comparator | Not described Receives: Drug: E2007 (6 mg) |
| Perampanel 8mg | Active comparator | Not described Receives: Drug: E2007 (8 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)
Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).
Measured: Baseline to Week 15/EOT
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Measured: Baseline to Week 15/EOT
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Measured: Baseline to Week 15/EOT
Mean Change in Average Pain Scores From Baseline at Each Study Week
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug.
Measured: Baseline, Week 1 to Week 17
Secondary outcomes (8)
Change in Average Sleep Interference Scores From Baseline to Week 15/EOT
Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]). Based on modified BOCF.
Measured: Baseline to Week 15/EOT
Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT
SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity.
Measured: Baseline and Week 15/EOT
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT
At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF.
Measured: Week 15/EOT
Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores
Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status.
Measured: Baseline and Week 15/EOT
Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores
HADS anxiety subscale score=sum of scores for 7 anxiety items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores, 0 to 21.
Measured: Baseline and Week 15/EOT
Withdrawal Due to Treatment Failure During Double-Blind Dosing Period
Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to 'lack of therapeutic efficacy,' the subject was counted as a withdrawal due to treatment failure.
Measured: Baseline and Week 15
Presence or Absence of Allodynia at Week 15/EOT
Investigators rated subjects' allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed.
Measured: Week 15/EOT
Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period
If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication.
Measured: Baseline to Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2008
- Study completionJul 2008
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 Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Limited
- Responsible party
- Sponsor
- Investigators
- Antonio Laurenza, M.D., Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505284
- Sponsor's protocol ID
- E2007-G000-227
- Other IDs
- 2006-006488-22
- Status last verified
- Feb 2013
- First submitted
- 20 Jul 2007
- Last updated
- 11 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00505284
- Acronym / sponsor ID
- E2007-G000-227
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetic neuropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eisai Limited
- Study start
- Jun 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Posted 8 Feb 2013
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 determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Perampanel 2mg | Active comparator | Drug: E2007 (2 mg) |
| Perampanel 4mg | Active comparator | Drug: E2007 (4 mg) |
| Perampanel 6mg | Active comparator | Drug: E2007 (6 mg) |
| Perampanel 8mg | Active comparator | Drug: E2007 (8 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Provide written informed consent, prior to entering the study or undergoing any study procedures
- Male and female patients ≥18 years of age will be eligible for enrollment. Females should be either not of childbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or intrauterine device [IUD]) for at least 1 month before Screening (Visit 1) and for 1 month after the end of the study (Visit 8). They must also have a negative serum beta-human chorionic gonadotropin (ß-hCG) at Screening (Visit 1). Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) starting with the Baseline Phase and continuing throughout the study period.
- Have Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration
- Have pain that has been stable over the past 6 months and, in the opinion of the investigator, not in an identifiably improving or worsening trend
- Have hemoglobin A1c ≤ 11%
Key exclusion criteria (20 listed)
- Patients with any one of the following will be excluded.
- Patients with any condition that could interfere with the conduct of the study or confound efficacy evaluations including the following:
- Patients motivated by secondary gain, or where there is a negative-incentive to achieving pain and functional pain relief (eg, litigation). This will be determined by the patient's medical history.
- Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, CNS, psychiatric, endocrine (other than diabetes), or immunologic, including patients with any of the following broad disease categories:
- Patients with any of the following laboratory abnormalities at Screening (Visit 1) or Baseline (Visit 2):
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 |
|---|---|---|
| PlaceboPlacebo tablets, once daily, for 15 weeks (taken orally). | Drug | Placebo |
| E2007 (2 mg)Also: PerampanelPerampanel, 2 mg once daily, for 15 weeks (taken orally). | Drug | Perampanel 2mg |
| E2007 (4 mg)Also: PerampanelPerampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally). | Drug | Perampanel 4mg |
| E2007 (6 mg)Also: PerampanelPerampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally). | Drug | Perampanel 6mg |
| E2007 (8 mg)Also: PerampanelPerampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally). | Drug | Perampanel 8mg |
Primary outcome
Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)
Time frame: Baseline to Week 15/EOT
Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score
Time frame: Baseline to Week 15/EOT
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score
Time frame: Baseline to Week 15/EOT
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Mean Change in Average Pain Scores From Baseline at Each Study Week
Time frame: Baseline, Week 1 to Week 17
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug.
8 secondary outcomes
Change in Average Sleep Interference Scores From Baseline to Week 15/EOT
Time frame: Baseline to Week 15/EOT
Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT
Time frame: Baseline and Week 15/EOT
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT
Time frame: Week 15/EOT
Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores
Time frame: Baseline and Week 15/EOT
Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores
Time frame: Baseline and Week 15/EOT
Withdrawal Due to Treatment Failure During Double-Blind Dosing Period
Time frame: Baseline and Week 15
Presence or Absence of Allodynia at Week 15/EOT
Time frame: Week 15/EOT
Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period
Time frame: Baseline to Week 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- 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.
Antonio Laurenza, M.D. study director
Eisai Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing E2007 (2 mg), E2007 (4 mg) and E2007 (6 mg) in people with Diabetic Neuropathy, run by Eisai Inc. at 1 site in United States.
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 16 inclusion and 20 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 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Feb 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 in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) (time frame: Baseline to Week 15/EOT). The study lists 4 primary outcomes in all. 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 11 Jul 2014.