Type 1 DiabetesPhase 2TADPOLNCT05594563
TArgeting Type 1 Diabetes Using POLyamines (TADPOL)
A Phase 2 study testing DFMO in people with Type 1 Diabetes, run by Emily K. Sims at 7 sites in United States.
Trial summary
The goal of this clinical trial is to test a drug known as DFMO in people with Type 1 Diabetes (T1D). The main question[s] it aims to answer are: Does it reduce stress on the cells that make insulin? Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks… Read more about this study
- Who is it for?
- Ages 4 to 40 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- DFMO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Mar 2023to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 4 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females 4- ≥40 years of age with a clinical diagnosis of T1D
- T1D clinical diagnosis with insulin start date no more than 100 days prior to the time of randomization
- Random non-fasting C-peptide level of >0.2 pmol/mL (equivalent to >0.6ng/ml) at screening.
- Positive for any one of the following diabetes-related autoantibodies (IAA, GAA, IA-2, or ZnT8)
- Treatment naïve of any immunomodulatory agent
- Normal hearing at screening, defined as acceptable results of pure-tone audiometry (<20 decibel [dB] baseline thresholds for all frequencies tested
Who cannot join
- Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, with the exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids. Presence of any psychiatric disorder that will affect ability to participate in study.
- Diabetes other than T1D
- Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
- Inability to swallow pills
- Psychiatric impairment or current use of anti-psychotic medication
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
Show all 18Show fewer
- Neutropenia (< 1,500 neutrophils/μL)
- Leukopenia (< 3,000 leukocytes /μL)
- Lymphopenia ( < 800 lymphocytes/μL)
- Thrombocytopenia (<100,000 platelets/μL)
- Clinically significant anemia or Hemoglobin as defined below:
- In Adults: Hgb <12.0g/dL in females and <13.0g/dL in males In Children: 12- <18: <11.4 g/dL in females and <12.4 g/dL in males In Children: 4- <12: Hgb <11.2 g/dL
- Impaired renal function (assessed by history and BUN/Creatinine, DFMO is renally excreted)
- Allergy to milk or soy (components of Boost® drink used for mixed meal tolerance testing)
- Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use 2 effective forms of birth control or be abstinent during the study period (see below). Male participants (including men who have had vasectomies) whose partners are pregnant or may be pregnant should use condoms while on study drug, until 2 weeks after discontinuation of drug, while the partner is pregnant.
- Active seizure disorder, defined as requiring chronic medication at the time of study or having had a seizure within the past 12 months at the time of screening
- Enrollment into another intervention trial.
- Use of an automated insulin delivery system, including hybrid closed loop or fully closed loop insulin pumps) that do not allow for manual suspension or temporary modification of insulin delivery for bolus dosing.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48109
Barbara Davis Center
Aurora, Colorado, 80045
University of Chicago
Chicago, Illinois, 60637
IU Health Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Mercy Hospital
Kansas City, Kansas, 64108
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
MHealth Fairview Masonic Children's Hospital and Specialty Clinics
Minneapolis, Minnesota, 55454
About this study
Official title: TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes
The goal of this clinical trial is to test a drug known as DFMO in people with Type 1 Diabetes (T1D). The main question[s] it aims to answer are:
- Does it reduce stress on the cells that make insulin?
- Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks like DFMO but has no active ingredients) two times a day for about 6 months. Participants will have 6 in person visits and 1 phone visit over a period of 12 months. Visits will include blood draws urine collection and other tests.
Read the detailed description
This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned, phase II clinical trial for individuals with recent onset type 1 diabetes. The investigators are conducting a double masked placebo-controlled intention to treat study enrolling persons with new onset T1D with documented continued residual C-peptide production. Within 45 days of screening and a run-in period during which eligibility will be determined and glycemic control optimized, subjects will have a 6-month double-masked treatment period with either DFMO or placebo. After a 6-month wash-out period the durability of effect will be assessed. Subjects will be randomly assigned either 1000mg/m2/day oral DFMO or placebo treatment at a 2:1 ratio.
- Conditions
- Type 1 Diabetes
- Being tested
- DFMO, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFMODrug
Also called Difluoromethylornithine
DFMO orally twice a day
PlaceboDrug
Placebo orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | Difluoromethylornithine (DFMO) pill ,1000mg/m2/day, for 6 months Receives: Drug: DFMO |
| Placebo Arm | Placebo comparator | Placebo pill taken twice a day orally for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of 1000 mg/m2/day of oral DFMO after 6 months of treatment
Primary endpoint defining clinical efficacy will be based on mixed-meal stimulated C-peptide area under the curve (AUC; in arbitrary units) in the treatment group compared to placebo after 6 months of DFMO treatment
Measured: 6 month
Number of participants with treatment-related adverse events as assessed by CTCAE v5
A summary of serious and non-serious adverse events (AEs) will be reported.
Measured: through study completion, an average of one year
Secondary outcomes (3)
Clinical efficacy of 1000 mg/m2/day of oral DFMO after 3 months of treatment, 9 months after treatment (or 3 months after treatment end), and 12 months after treatment (or 6 months after treatment end).
Secondary endpoints will be based on mixed meal stimulated C-peptide AUC (arbitrary units) at 3 months after treatment, 9 months after treatment, and 12 months after treatment.
Measured: through study completion, an average of one year
Decrease in urinary polyamides after 6 months of DFMO treatment.
Decrease in urinary putrescine (in umol/g Cr) from baseline after 6 months of DFMO treatment, measured using high performance liquid chromatography.
Measured: up to 24 weeks after treatment
Biomarkers of β cell stress at 3, 6, 9, and 12 months after treatment.
Fasting and stimulated proinsulin/c-peptide ratios (%) will be measured using immunoassays and reported at baseline, 3 months after treatment, 6 months after treatment, 9 months after treatment, and 12 months after treatment.
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start14 Mar 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Model description
- Subject are randomized to either treatment or placebo arm.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emily K. Sims
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Cancer Prevention Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Emily K. Sims, Indiana University
- Investigators
- Emily K Sims, MD,MS, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594563
- Sponsor's protocol ID
- 4-SRA-2022-1205-M-B
- Acronym
- TADPOL
- Status last verified
- Apr 2026
- First submitted
- 12 Oct 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brooks WH. Autoimmune diseases and polyamines. Clin Rev Allergy Immunol. 2012 Feb;42(1):58-70. doi: 10.1007/s12016-011-8290-y.
PubMed 22116709Seiler N. Catabolism of polyamines. Amino Acids. 2004 Jun;26(3):217-33. doi: 10.1007/s00726-004-0070-z. Epub 2004 Apr 20.
PubMed 15221502Jeter JM, Alberts DS. Difluoromethylornithine: the proof is in the polyamines. Cancer Prev Res (Phila). 2012 Dec;5(12):1341-4. doi: 10.1158/1940-6207.CAPR-12-0429.
PubMed 23221207Maier B, Tersey SA, Mirmira RG. Hypusine: a new target for therapeutic intervention in diabetic inflammation. Discov Med. 2010 Jul;10(50):18-23.
PubMed 20670594Bardocz S, Duguid TJ, Brown DS, Grant G, Pusztai A, White A, Ralph A. The importance of dietary polyamines in cell regeneration and growth. Br J Nutr. 1995 Jun;73(6):819-28. doi: 10.1079/bjn19950087.
PubMed 7632663Renaudineau Y, Youinou P. Epigenetics and autoimmunity, with special emphasis on methylation. Keio J Med. 2011;60(1):10-6. doi: 10.2302/kjm.60.10.
PubMed 21460598McCann PP, Pegg AE. Ornithine decarboxylase as an enzyme target for therapy. Pharmacol Ther. 1992;54(2):195-215. doi: 10.1016/0163-7258(92)90032-u.
PubMed 1438532Hong SK, Chaturvedi R, Piazuelo MB, Coburn LA, Williams CS, Delgado AG, Casero RA Jr, Schwartz DA, Wilson KT. Increased expression and cellular localization of spermine oxidase in ulcerative colitis and relationship to disease activity. Inflamm Bowel Dis. 2010 Sep;16(9):1557-66. doi: 10.1002/ibd.21224.
PubMed 20127992Maier B, Ogihara T, Trace AP, Tersey SA, Robbins RD, Chakrabarti SK, Nunemaker CS, Stull ND, Taylor CA, Thompson JE, Dondero RS, Lewis EC, Dinarello CA, Nadler JL, Mirmira RG. The unique hypusine modification of eIF5A promotes islet beta cell inflammation and dysfunction in mice. J Clin Invest. 2010 Jun;120(6):2156-70. doi: 10.1172/JCI38924. Epub 2010 May 24.
PubMed 20501948Templin AT, Maier B, Nishiki Y, Tersey SA, Mirmira RG. Deoxyhypusine synthase haploinsufficiency attenuates acute cytokine signaling. Cell Cycle. 2011 Apr 1;10(7):1043-9. doi: 10.4161/cc.10.7.15206. Epub 2011 Apr 1.
PubMed 21389784Bjelakovic G, Beninati S, Bjelakovic B, Sokolovic D, Jevtovic T, Stojanovic I, Rossi S, Tabolacci C, Kocic G, Pavlovic D, Saranac Lj, Zivic S. Does polyamine oxidase activity influence the oxidative metabolism of children who suffer of diabetes mellitus? Mol Cell Biochem. 2010 Aug;341(1-2):79-85. doi: 10.1007/s11010-010-0439-0. Epub 2010 Apr 20.
PubMed 20405312Nishiki Y, Adewola A, Hatanaka M, Templin AT, Maier B, Mirmira RG. Translational control of inducible nitric oxide synthase by p38 MAPK in islet beta-cells. Mol Endocrinol. 2013 Feb;27(2):336-49. doi: 10.1210/me.2012-1230. Epub 2012 Dec 18.
PubMed 23250488Higashi K, Yoshida M, Igarashi A, Ito K, Wada Y, Murakami S, Kobayashi D, Nakano M, Sohda M, Nakajima T, Narita I, Toida T, Kashiwagi K, Igarashi K. Intense correlation between protein-conjugated acrolein and primary Sjogren's syndrome. Clin Chim Acta. 2010 Mar;411(5-6):359-63. doi: 10.1016/j.cca.2009.11.032. Epub 2009 Dec 5.
PubMed 19968980Furumitsu Y, Yukioka K, Kojima A, Yukioka M, Shichikawa K, Ochi T, Matsui-Yuasa I, Otani S, Nishizawa Y, Morii H. Levels of urinary polyamines in patients with rheumatoid arthritis. J Rheumatol. 1993 Oct;20(10):1661-5.
PubMed 8295175Furumitsu Y, Yukioka K, Yukioka M, Ochi T, Morishima Y, Matsui-Yuasa I, Otani S, Inaba M, Nishizawa Y, Morii H. Interleukin-1beta induces elevation of spermidine/spermine N1-acetyltransferase activity and an increase in the amount of putrescine in synovial adherent cells from patients with rheumatoid arthritis. J Rheumatol. 2000 Jun;27(6):1352-7.
PubMed 10852253
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05594563
- Acronym / sponsor ID
- TADPOL / 4-SRA-2022-1205-M-B
- Conditions
- Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Emily K. SimsUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Cancer Prevention Pharmaceuticals, Inc.
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Oct 2022 (actual)
- 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 goal of this clinical trial is to test a drug known as DFMO in people with Type 1 Diabetes (T1D). The main question[s] it aims to answer are:
- Does it reduce stress on the cells that make insulin?
- Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks like DFMO but has no active ingredients) two times a day for about 6 months. Participants will have 6 in person visits and 1 phone visit over a period of 12 months. Visits will include blood draws urine collection and other tests.
Detailed description
This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned, phase II clinical trial for individuals with recent onset type 1 diabetes. The investigators are conducting a double masked placebo-controlled intention to treat study enrolling persons with new onset T1D with documented continued residual C-peptide production. Within 45 days of screening and a run-in period during which eligibility will be determined and glycemic control optimized, subjects will have a 6-month double-masked treatment period with either DFMO or placebo. After a 6-month wash-out period the durability of effect will be assessed. Subjects will be randomly assigned either 1000mg/m2/day oral DFMO or placebo treatment at a 2:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subject are randomized to either treatment or placebo arm.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Drug: DFMODifluoromethylornithine (DFMO) pill ,1000mg/m2/day, for 6 months |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo pill taken twice a day orally for 6 months |
Who may qualify
- Ages
- 4 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males and females 4- ≥40 years of age with a clinical diagnosis of T1D
- T1D clinical diagnosis with insulin start date no more than 100 days prior to the time of randomization
- Random non-fasting C-peptide level of >0.2 pmol/mL (equivalent to >0.6ng/ml) at screening.
- Positive for any one of the following diabetes-related autoantibodies (IAA, GAA, IA-2, or ZnT8)
- Treatment naïve of any immunomodulatory agent
Key exclusion criteria (18 listed)
- Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, with the exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids. Presence of any psychiatric disorder that will affect ability to participate in study.
- Diabetes other than T1D
- Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
- Inability to swallow pills
- Psychiatric impairment or current use of anti-psychotic medication
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 |
|---|---|---|
| DFMOAlso: DifluoromethylornithineDFMO orally twice a day | Drug | Treatment Arm |
| PlaceboPlacebo orally twice a day | Drug | Placebo Arm |
Primary outcome
Clinical efficacy of 1000 mg/m2/day of oral DFMO after 6 months of treatment
Time frame: 6 month
Primary endpoint defining clinical efficacy will be based on mixed-meal stimulated C-peptide area under the curve (AUC; in arbitrary units) in the treatment group compared to placebo after 6 months of DFMO treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5
Time frame: through study completion, an average of one year
A summary of serious and non-serious adverse events (AEs) will be reported.
3 secondary outcomes
Clinical efficacy of 1000 mg/m2/day of oral DFMO after 3 months of treatment, 9 months after treatment (or 3 months after treatment end), and 12 months after treatment (or 6 months after treatment end).
Time frame: through study completion, an average of one year
Decrease in urinary polyamides after 6 months of DFMO treatment.
Time frame: up to 24 weeks after treatment
Biomarkers of β cell stress at 3, 6, 9, and 12 months after treatment.
Time frame: through study completion, an average of one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 22116709Brooks WH. Autoimmune diseases and polyamines. Clin Rev Allergy Immunol. 2012 Feb;42(1):58-70. doi: 10.1007/s12016-011-8290-y.
- Background: PubMed 15221502Seiler N. Catabolism of polyamines. Amino Acids. 2004 Jun;26(3):217-33. doi: 10.1007/s00726-004-0070-z. Epub 2004 Apr 20.
- Background: PubMed 23221207Jeter JM, Alberts DS. Difluoromethylornithine: the proof is in the polyamines. Cancer Prev Res (Phila). 2012 Dec;5(12):1341-4. doi: 10.1158/1940-6207.CAPR-12-0429.
- Background: PubMed 20670594Maier B, Tersey SA, Mirmira RG. Hypusine: a new target for therapeutic intervention in diabetic inflammation. Discov Med. 2010 Jul;10(50):18-23.
- Background: PubMed 7632663Bardocz S, Duguid TJ, Brown DS, Grant G, Pusztai A, White A, Ralph A. The importance of dietary polyamines in cell regeneration and growth. Br J Nutr. 1995 Jun;73(6):819-28. doi: 10.1079/bjn19950087.
- Background: PubMed 21460598Renaudineau Y, Youinou P. Epigenetics and autoimmunity, with special emphasis on methylation. Keio J Med. 2011;60(1):10-6. doi: 10.2302/kjm.60.10.
- Background: PubMed 1438532McCann PP, Pegg AE. Ornithine decarboxylase as an enzyme target for therapy. Pharmacol Ther. 1992;54(2):195-215. doi: 10.1016/0163-7258(92)90032-u.
- Results publication: PubMed 20127992Hong SK, Chaturvedi R, Piazuelo MB, Coburn LA, Williams CS, Delgado AG, Casero RA Jr, Schwartz DA, Wilson KT. Increased expression and cellular localization of spermine oxidase in ulcerative colitis and relationship to disease activity. Inflamm Bowel Dis. 2010 Sep;16(9):1557-66. doi: 10.1002/ibd.21224.
- Results publication: PubMed 20501948Maier B, Ogihara T, Trace AP, Tersey SA, Robbins RD, Chakrabarti SK, Nunemaker CS, Stull ND, Taylor CA, Thompson JE, Dondero RS, Lewis EC, Dinarello CA, Nadler JL, Mirmira RG. The unique hypusine modification of eIF5A promotes islet beta cell inflammation and dysfunction in mice. J Clin Invest. 2010 Jun;120(6):2156-70. doi: 10.1172/JCI38924. Epub 2010 May 24.
- Results publication: PubMed 21389784Templin AT, Maier B, Nishiki Y, Tersey SA, Mirmira RG. Deoxyhypusine synthase haploinsufficiency attenuates acute cytokine signaling. Cell Cycle. 2011 Apr 1;10(7):1043-9. doi: 10.4161/cc.10.7.15206. Epub 2011 Apr 1.
- Results publication: PubMed 20405312Bjelakovic G, Beninati S, Bjelakovic B, Sokolovic D, Jevtovic T, Stojanovic I, Rossi S, Tabolacci C, Kocic G, Pavlovic D, Saranac Lj, Zivic S. Does polyamine oxidase activity influence the oxidative metabolism of children who suffer of diabetes mellitus? Mol Cell Biochem. 2010 Aug;341(1-2):79-85. doi: 10.1007/s11010-010-0439-0. Epub 2010 Apr 20.
- Results publication: PubMed 23250488Nishiki Y, Adewola A, Hatanaka M, Templin AT, Maier B, Mirmira RG. Translational control of inducible nitric oxide synthase by p38 MAPK in islet beta-cells. Mol Endocrinol. 2013 Feb;27(2):336-49. doi: 10.1210/me.2012-1230. Epub 2012 Dec 18.
- Individual participant dataSharing planned: No
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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.
Emily K Sims, MD,MS study chair
Indiana University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFMO in people with Type 1 Diabetes, run by Emily K. Sims at 7 sites 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 6 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical efficacy of 1000 mg/m2/day of oral DFMO after 6 months of treatment (time frame: 6 month). 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?
On the ClinicalTrials.gov record for NCT05594563, which also lists 52 linked publications.
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 Aug 2026.