HeadachePhase 1/2NCT02947022

Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease

A Phase 1/2 study testing Calcium DTPA and Zinc DTPA in people with Headache and Cognitive Disturbance, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Purpose: There are two goals we have for this prospective single arm study; to see an increase in the amount of gadolinium in 24 hour urine collection following each infusion treatment with Calcium and Zinc DTPA, and to see a reduction or elimination of gadolinium deposition disease (GDD) symptoms. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Headache, Cognitive Disturbance, Skin Hyperpigmentation
What is being tested?: Calcium DTPA and Zinc DTPA
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: Oct 2016to 31 Jan 2017
Phase: Phase 1/2
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Pregnant or lactating
Less than 18 years old
No evidence of gadolinium (has to have shown previous demonstration of Gd by urine analysis or bone biopsy)
Known connective tissue disease such as Systemic Lupus Erythematosus or Scleroderma
Severe hemochromatosis or Wilson's disease
Glomerular Filtration Rate (GFR) ≤ 60

Show all 11Show fewer

Have had an investigational drug within last 30 days
Unable to give written consent
Multiple Sclerosis
Chronic heart failure
Cirrhosis of the liver

Trial locations and contacts

1 site in 1 country.

United States1 site

UNC Hospitals
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Investigator Initiated Investigational New Drug Application to Study the Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease

Participants: Twenty (20) patients who are suffering from gadolinium deposition disease (GDD)

Procedures: Over a series of three (3) treatment time-points patients will be treated with IV Ca-DTPA on day one, and Zn-DTPA on day two.

Conditions: Headache, Cognitive Disturbance, Skin Hyperpigmentation, Arthralgia
Being tested: Calcium DTPA, Zinc DTPA
Keywords: gadolinium, deposition, GBCA, Extremity Pain, Skin Pain, Chest Wall Pain
Medical subject headings: Headache, Cognition Disorders, Hyperpigmentation, Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calcium DTPADrug
Also called Pentetate calcium trisodium injection
On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.
The same treatment therapy will consist of 3 time-points, approximately 1 month apart.
Zinc DTPADrug
Also called Pentetate zinc trisodium injection
On Day 2, 2.5 mL of Zn-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Zn-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.
The same treatment therapy will consist of 3 time-points, approximately 1 month apart.

Study groups in NCT02947022
Study group	Role	What they receive
Calcium DTPA followed by Zinc DTPA	Experimental	Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3. Receives: Drug: Calcium DTPA; Drug: Zinc DTPA

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Measured: Baseline, Month 1
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Measured: Baseline, Month 1

Secondary outcomes (14)

Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Measured: Baseline, Month 2
Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Measured: Baseline, Month 2
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Measured: Baseline, Month 3
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Measured: Baseline, Month 3
Change From Baseline to Month 1 in the Pain Score
Patient self-reported pain scores assessed using a Visual Analog Scale (VAS) ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Measured: Baseline, Month 1 (Day 7)
Change From Baseline to Month 2 in the Pain Score
Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Measured: Baseline, Month 2 (Day 7)
Change From Baseline to Month 3 in the Pain Score
Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Measured: Baseline, Month 3 (Day 7)
Change From Baseline to Month 6 in the Pain Score
Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Measured: Baseline, Month 6
Change From Baseline to Month 12 in the Pain Score
Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain".
Measured: Baseline, Month 12
Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Measured: Baseline, Month 1 (day 7)
Change in ACPA QOL Score From Baseline to Month 2
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Measured: Baseline, Month 2 (day 7)
Change in ACPA QOL Score at Month 3
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Measured: Baseline, Month 3 (day 7)
Change in ACPA QOL Score at Month 6
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Measured: Baseline, Month 6
Change in ACPA QOL Score at Month 12
The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life".
Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201631 Jan 2017

First posted27 Oct 2016 (estimated)
Study startOct 2016
Primary completion31 Jan 2017
Study completion31 Jan 2017

Why it stopped: PI left institution.

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 HeadacheStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02947022
Sponsor's protocol ID: 16-1080
Status last verified: Feb 2018
First submitted: 25 Oct 2016
Last updated: 6 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura

All Headache trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigator Initiated Investigational New Drug Application to Study the Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease
ClinicalTrials.gov ID: NCT02947022
Acronym / sponsor ID: 16-1080
Conditions: Headache, Cognitive Disturbance, Skin Hyperpigmentation, Arthralgia
Keywords: gadolinium, deposition, GBCA, Extremity Pain, Skin Pain, Chest Wall Pain
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: PI left institution.
Enrolment: 1 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Hameln Pharma GmbH
Study start: Oct 2016
Primary completion: 31 Jan 2017 (actual)
Study completion: 31 Jan 2017 (actual)
First posted: 27 Oct 2016 (estimated)
Results: Posted 6 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants: Twenty (20) patients who are suffering from gadolinium deposition disease (GDD)

Procedures: Over a series of three (3) treatment time-points patients will be treated with IV Ca-DTPA on day one, and Zn-DTPA on day two.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Calcium DTPA followed by Zinc DTPA	Experimental	Drug: Calcium DTPA, Drug: Zinc DTPASubjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (11 listed)

Pregnant or lactating
Less than 18 years old
No evidence of gadolinium (has to have shown previous demonstration of Gd by urine analysis or bone biopsy)
Known connective tissue disease such as Systemic Lupus Erythematosus or Scleroderma
Severe hemochromatosis or Wilson's disease

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
Calcium DTPAAlso: Pentetate calcium trisodium injectionOn Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening. The same treatment therapy will consist of 3 time-points, approximately 1 month apart.	Drug	Calcium DTPA followed by Zinc DTPA
Zinc DTPAAlso: Pentetate zinc trisodium injectionOn Day 2, 2.5 mL of Zn-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Zn-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening. The same treatment therapy will consist of 3 time-points, approximately 1 month apart.	Drug	Calcium DTPA followed by Zinc DTPA

Primary outcome

Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time frame: Baseline, Month 1
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time frame: Baseline, Month 1

14 secondary outcomes

Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time frame: Baseline, Month 2
Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time frame: Baseline, Month 2
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time frame: Baseline, Month 3
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time frame: Baseline, Month 3
Change From Baseline to Month 1 in the Pain Score
Time frame: Baseline, Month 1 (Day 7)
Change From Baseline to Month 2 in the Pain Score
Time frame: Baseline, Month 2 (Day 7)
Change From Baseline to Month 3 in the Pain Score
Time frame: Baseline, Month 3 (Day 7)
Change From Baseline to Month 6 in the Pain Score
Time frame: Baseline, Month 6
Change From Baseline to Month 12 in the Pain Score
Time frame: Baseline, Month 12
Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1
Time frame: Baseline, Month 1 (day 7)
Change in ACPA QOL Score From Baseline to Month 2
Time frame: Baseline, Month 2 (day 7)
Change in ACPA QOL Score at Month 3
Time frame: Baseline, Month 3 (day 7)
Change in ACPA QOL Score at Month 6
Time frame: Baseline, Month 6
Change in ACPA QOL Score at Month 12
Time frame: Baseline, Month 12

Results and safety

Results posted to the registry on 6 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Calcium DTPA Followed by Zinc DTPA	1	0

Primary outcome: Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.

Time frame: Baseline, Month 1

Population analysed: Data were not analyzed because this study was stopped prematurely.

Primary outcome: Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.

Time frame: Baseline, Month 1

Population analysed: Data were not analyzed because this study was stopped prematurely.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout treatment and for 12 days after the last dose (or cessation), an average of 2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Calcium DTPA Followed by Zinc DTPA	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): The study was stopped on 1/31/16. Only 1 patient received 1 treatment prior to the study stopping.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Headache

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura

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.

Richard Semelka, MD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Calcium DTPA and Zinc DTPA in people with Headache and Cognitive Disturbance, run by University of North Carolina, Chapel Hill 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 0 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 Apr 2018. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 6 Apr 2018). 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 From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. (time frame: Baseline, Month 1). 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 NCT02947022.

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 6 Apr 2018.