Thyroid Eye DiseasePhase 2/3NCT02422368
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
A Phase 2/3 study testing Methylprednisolone + ASTED in people with Thyroid Eye Disease, run by Iran University of Medical Sciences at 2 sites in Iran.
Trial summary
ASTED (Antioxidant Supplements for TED) trial is an investigator-initiated, randomized, triple masked, clinical trial of a selected combination of vitamins and minerals versus placebo in patients with moderate to severe thyroid eye disease. The trial has a parallel-arm design. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- Methylprednisolone + ASTED
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesIran
- Study dates
- 1 Sep 2022to Nov 2024
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe TED of less than 18 months duration:
- Active state (Clinical activity score of 3 and more).
- No steroid and or any supplement treatment for the last 6 months.
- Euthyroidism
- Age 18-70 years.
Who cannot join
- Sight-threatening TED
- Pregnancy
- Drug and/or alcohol abuse
- Severe concomitant illness
- Inability to comply with the study protocol
- No informed consent
- Developing more severe TED (Sight threatening TED) in the course of the trial.
- Contraindications of steroid treatment.
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Private Thyroid eye disease clinic
Tehran, 14455
Rassoul Akram Hospital
Tehran
About this study
Official title: The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial
ASTED (Antioxidant Supplements for TED) trial is an investigator-initiated, randomized, triple masked, clinical trial of a selected combination of vitamins and minerals versus placebo in patients with moderate to severe thyroid eye disease. The trial has a parallel-arm design.
Read the detailed description
Primary aim: To investigate if ASTED or as compared with placebo could affect the course of TED either by enhancing improvement or preventing worsening in patients with Moderate to severe TED thyroid eye disease (TED) based on:
- Total eye score (NOSPECS severity score) 1 Total eye score is used to assess the severity of TED, which was calculated by multiplying each class of the NOSPECS system1 (except class 0) to its grade of severity (0-3), yielding a maximum total score of 63 and a minimum total score of 0 (the higher the number the worse the severity) The overall ophthalmic outcome is a composite score based on multiple items (Soft tissue, retraction, proptosis, diplopia, and corneal involvement); the use of a composite score circumvents the problem arising from the presence of improvement in one item and simultaneous worsening in another item. The severity score in each of the classes 1, 2, 3, and 4 will also be separately compared to evaluate the effect of different treatments on each sign.
- Score of thyroid eye disease Quality of life questionnaire (TED-QOL) 2.
Secondary outcomes measures:
To compare possible change in:
- Clinical activity score (CAS Score) 3 (7 items are scored in the beginning and 10 items are scored at 3 and 6 months)
- Serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin) at 0, 3 and 6 months. Thyroid function test (Free T4, T3, and TSH) will be measured in all 3 visits0
- Side effects
- Conditions
- Thyroid Eye Disease
- Being tested
- Methylprednisolone + ASTED, Methylprednisolone +Placebo
- Keywords
- Graves' ophthalmopathy, Antioxidant, Activity, Severity
- Medical subject headings
- Graves Ophthalmopathy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone + ASTEDDrug
ASTED tablet: Twice daily for 6 months
Methylprednisolone:
Methylprednisolone tablet of 50 and 5 mg, company….) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow ups.
Methylprednisolone +PlaceboDrug
Placebo: twice daily
Methylprednisolone:
Methylprednisolone tablet of 50 and 5 mg, company….) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow ups.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone + ASTED | Experimental | ASTED (Antioxidant Supplements for Thyroid Eye Disease) includes : B-Carotene (6 mg)+ Vit.C (200 mg) + Vit.E (200 mg) + Nicotinamide(20mg) + Selenium(200mic.) + Zinc oxide (8 mg) + Copper gluconate or oxide (1mg) + Manganese chloride (1.8 mg), Twice a day for 6 months
Methylprednisolone includes :
Methylprednisolone tablet of 50 and 5 mg, company….) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow up. Receives: Drug: Methylprednisolone + ASTED |
| Methylprednisolone + Placebo | Placebo comparator | Placebo Twice a day for 6 months Methylprednisolone prescribes as the same as arm 1 Receives: Drug: Methylprednisolone +Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of total eye score changes (using NOSPECS severity score)
Total eye score change during study
Measured: baseline, 1 month, 3 months, 6 months
Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL)
Changing quality of life during study period
Measured: baseline, 1 month, 3 months, 6 months
Secondary outcomes (3)
Mean of clinical activity score changes (CAS Score)
Change of clinical activity score during study period
Measured: baseline, 1 month, 3 months, 6 months
Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin)
Change of serum thyroid auto-antibodies during study period
Measured: baseline, 1 month, 3 months, 6 months
Changes of thyroid function test (Free T4, T3, and TSH) Levels
Change of thyroid function test during study period
Measured: baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start1 Sep 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: Do not access to the drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohsen B Kashkouli, MD, Principal investigator, IUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422368
- Sponsor's protocol ID
- 93-02-124-24581
- Status last verified
- Jan 2021
- First submitted
- 11 Apr 2015
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02422368
- Acronym / sponsor ID
- 93-02-124-24581
- Conditions
- Thyroid Eye Disease
- Keywords
- Graves' ophthalmopathy, Antioxidant, Activity, Severity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Do not access to the drug
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 21 Apr 2015 (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.
ASTED (Antioxidant Supplements for TED) trial is an investigator-initiated, randomized, triple masked, clinical trial of a selected combination of vitamins and minerals versus placebo in patients with moderate to severe thyroid eye disease. The trial has a parallel-arm design.
Detailed description
Primary aim: To investigate if ASTED or as compared with placebo could affect the course of TED either by enhancing improvement or preventing worsening in patients with Moderate to severe TED thyroid eye disease (TED) based on:
- Total eye score (NOSPECS severity score) 1 Total eye score is used to assess the severity of TED, which was calculated by multiplying each class of the NOSPECS system1 (except class 0) to its grade of severity (0-3), yielding a maximum total score of 63 and a minimum total score of 0 (the higher the number the worse the severity) The overall ophthalmic outcome is a composite score based on multiple items (Soft tissue, retraction, proptosis, diplopia, and corneal involvement); the use of a composite score circumvents the problem arising from the presence of improvement in one item and simultaneous worsening in another item. The severity score in each of the classes 1, 2, 3, and 4 will also be separately compared to evaluate the effect of different treatments on each sign.
- Score of thyroid eye disease Quality of life questionnaire (TED-QOL) 2.
Secondary outcomes measures:
To compare possible change in:
- Clinical activity score (CAS Score) 3 (7 items are scored in the beginning and 10 items are scored at 3 and 6 months)
- Serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin) at 0, 3 and 6 months. Thyroid function test (Free T4, T3, and TSH) will be measured in all 3 visits0
- Side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone + ASTED | Experimental | Drug: Methylprednisolone + ASTEDASTED (Antioxidant Supplements for Thyroid Eye Disease) includes : B-Carotene (6 mg)+ Vit.C (200 mg) + Vit.E (200 mg) + Nicotinamide(20mg) + Selenium(200mic.) + Zinc oxide (8 mg) + Copper gluconate or oxide (1mg) + Manganese chloride (1.8 mg), Twice a day for 6 months Methylprednisolone includes : Methylprednisolone tablet of 50 and 5 mg, company….) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow up. |
| Methylprednisolone + Placebo | Placebo comparator | Drug: Methylprednisolone +PlaceboPlacebo Twice a day for 6 months Methylprednisolone prescribes as the same as arm 1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate to severe TED of less than 18 months duration:
- Active state (Clinical activity score of 3 and more).
- No steroid and or any supplement treatment for the last 6 months.
- Euthyroidism
- Age 18-70 years.
Key exclusion criteria (8 listed)
- Sight-threatening TED
- Pregnancy
- Drug and/or alcohol abuse
- Severe concomitant illness
- Inability to comply with the study protocol
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 |
|---|---|---|
| Methylprednisolone + ASTEDASTED tablet: Twice daily for 6 months Methylprednisolone: Methylprednisolone tablet of 50 and 5 mg, company….) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow ups. | Drug | Methylprednisolone + ASTED |
| Methylprednisolone +PlaceboPlacebo: twice daily Methylprednisolone: Methylprednisolone tablet of 50 and 5 mg, company….) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow ups. | Drug | Methylprednisolone + Placebo |
Primary outcome
Mean of total eye score changes (using NOSPECS severity score)
Time frame: baseline, 1 month, 3 months, 6 months
Total eye score change during study
Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL)
Time frame: baseline, 1 month, 3 months, 6 months
Changing quality of life during study period
3 secondary outcomes
Mean of clinical activity score changes (CAS Score)
Time frame: baseline, 1 month, 3 months, 6 months
Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin)
Time frame: baseline, 1 month, 3 months, 6 months
Changes of thyroid function test (Free T4, T3, and TSH) Levels
Time frame: baseline, 1 month, 3 months, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
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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.
Mohsen B Kashkouli, MD principal investigator
IUMS
2 sites 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 Methylprednisolone + ASTED in people with Thyroid Eye Disease, run by Iran University of Medical Sciences at 2 sites in Iran.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean of total eye score changes (using NOSPECS severity score) (time frame: baseline, 1 month, 3 months, 6 months). 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 10 Jan 2022.