Painful Diabetic NeuropathyPhase 3NCT00546351
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
A Phase 3 study testing Lacosamide in people with Painful Diabetic Neuropathy, run by UCB Pharma at 101 sites in 15 countries.
Trial summary
SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Lacosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- 101 sitesin 15 countries
- Study dates
- May 2004to Jan 2011
- Phase
- Phase 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
- Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued
- SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor
Who cannot join
- Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)
- Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥3 times the upper limit of the normal range (ULN) with total bilirubin ≥2 times ULN or transaminases (AST and/or ALT) ≥5 times ULN
- Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial
- Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception
Trial locations and contacts
101 sites in 15 countries.
101 sites in 15 countries
Germany22 sites
040
Bad Saarow
052
Beckum
049
Berlin
051
Berlin
056
Berlin
242
Berlin
249
Berlin
247
Bochum
041
Hamburg
045
Hamburg
054
Hamburg
244
Jena
058
Köthen
043
Künzing
050
Leipzig
053
Leipzig
250
Leipzig
046
Mittweida
243
München
246
Schwerin
044
Stuhr-Brinkum
248
Witten
Poland14 sites
092
Bialystok
293
Bialystok
094
Bydgoszcz
095
Częstochowa
091
Gdansk
093
Gdansk
294
Krakow
297
Krakow
090
Lodz
295
Lodz
291
Radom
292
Warsaw
296
Warsaw
290
Ząbkowicki
Hungary11 sites
060
Budapest
062
Budapest
061
Győr
262
Kecskemét
260
Makó
266
Nyíregyháza
064
Szeged
265
Székesfehérvár
264
Szolnok
263
Tatabánya
261
Veszprém
Bulgaria10 sites
011
Pleven
014
Plovdiv
017
Plovdiv
019
Rousse
012
Sofia
013
Sofia
015
Sofia
016
Sofia
210
Stara Zagora
010
Varna
Czechia8 sites
028
Brno
220
Chomutov
026
Litoměřice
027
Olomouc
024
Ostrava-Poruba
029
Písek
021
Prague
022
Prague
Romania7 sites
100
Bucharest
102
Bucharest
107
Bucharest
108
Bucharest
109
Bucharest
101
Cluj-Napoca
103
Timișoara
Belgium6 sites
003
Antwerp
006
Bonheiden
002
Genk
001
Leuven
005
Merksem
004
Roeselare
United Kingdom5 sites
159
Bath
154
Bristol
152
Leeds
150
Morriston
151
Newport
About this study
Official title: A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.
SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Lacosamide
- Keywords
- Lacosamide
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called Vimpat
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years. Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Measured: From entry Visit 1 through end of treatment (approximately 6.5 years)
Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
- Is fatal
- Is life-threatening
- Results in persistent or significant disability/incapacity
- Requires inpatient hospitalization
- Prolongs existing inpatient hospitalization
- Is a congenital anomaly/birth defect
- Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above
Measured: From entry Visit 1 through end of treatment (approximately 6.5 years)
Secondary outcomes (23)
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.
On the Likert Scale, 0 = no pain and 10 = worst possible pain.
Measured: Baseline
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.
On the Likert Scale, 0 = no pain and 10 = worst possible pain.
Measured: Last Visit (approximately 2 years)
Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.
Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.
Measured: Baseline
Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.
On VAS 0 mm = no pain and 100 mm = worst possible pain.
Measured: Last Visit (approximately 2 years)
Patient's Global Impression of Change (PGIC) at Last Visit.
The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).
Measured: Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.
0 = no pain and 10 = most intense pain sensation imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.
0 = not sharp and 10 = most sharp sensation imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.
0 = not hot and 10 = the most hot sensation imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.
0 = not cold and 10 = the coldest sensation imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.
0 = not dull and 10 = most dull sensation imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.
0 = not unpleasant and 10 = most unpleasant sensation imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.
0 = no surface pain and 10 = most intense surface pain imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.
0 = no deep pain and 10 = most intense deep pain imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.
0 = not itchy and 10 = most itchy sensation imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.
0 = not sensitive and 10 = most sensitive sensation imaginable.
Measured: Baseline Visit; Last Visit (approximately 2 years)
Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.
0 = no interference with sleep and 10 = worst possible interference with sleep.
Measured: Baseline
Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.
0 = no interference with sleep and 10 = worst possible interference with sleep.
Measured: Last Visit
Average Pain Interference With Activity (11-point Likert Scale) at Baseline.
0 = no interference with activity and 10 = worst possible interference with activity.
Measured: Baseline
Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.
0 = no interference with activity and 10 = worst possible interference with activity.
Measured: Last Visit
Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Measured: Baseline
Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Measured: Last Visit
Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Measured: Baseline
Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Measured: Last Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startMay 2004
- Primary completionJan 2011
- Study completionJan 2011
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 Painful Diabetic NeuropathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546351
- Sponsor's protocol ID
- SP0746
- Other IDs
- 2004-000551-42, 2004
- Status last verified
- Aug 2023
- First submitted
- 16 Oct 2007
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.
- ClinicalTrials.gov ID
- NCT00546351
- Acronym / sponsor ID
- SP0746
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Lacosamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Oct 2007 (estimated)
- Results
- Posted 19 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | Experimental | Drug: Lacosamide50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued
- SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor
Key exclusion criteria (4 listed)
- Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)
- Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥3 times the upper limit of the normal range (ULN) with total bilirubin ≥2 times ULN or transaminases (AST and/or ALT) ≥5 times ULN
- Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial
- Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception
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 |
|---|---|---|
| LacosamideAlso: Vimpat50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years | Drug | Lacosamide |
Primary outcome
Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
Time frame: From entry Visit 1 through end of treatment (approximately 6.5 years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
Time frame: From entry Visit 1 through end of treatment (approximately 6.5 years)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Is fatal * Is life-threatening * Results in persistent or significant disability/incapacity * Requires inpatient hospitalization * Prolongs existing inpatient hospitalization * Is a congenital anomaly/birth defect * Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above
23 secondary outcomes
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.
Time frame: Baseline
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.
Time frame: Last Visit (approximately 2 years)
Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.
Time frame: Baseline
Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.
Time frame: Last Visit (approximately 2 years)
Patient's Global Impression of Change (PGIC) at Last Visit.
Time frame: Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.
Time frame: Baseline Visit; Last Visit (approximately 2 years)
Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.
Time frame: Baseline
Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.
Time frame: Last Visit
Average Pain Interference With Activity (11-point Likert Scale) at Baseline.
Time frame: Baseline
Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.
Time frame: Last Visit
Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.
Time frame: Baseline
Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.
Time frame: Last Visit
Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.
Time frame: Baseline
Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.
Time frame: Last Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
101 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lacosamide in people with Painful Diabetic Neuropathy, run by UCB Pharma at 101 sites in 15 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 2 inclusion and 4 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in Germany, Poland, Hungary, Bulgaria, Czechia and 10 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. 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 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 19 Apr 2012). 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?
Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years). (time frame: From entry Visit 1 through end of treatment (approximately 6.5 years)). The study lists 2 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 21 Sep 2023.