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

Headache Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02947022
• Other study ID #: 16-1080
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: October 25, 2016
• Last updated: April 5, 2018
• Start date: October 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: February 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria: Exhibiting 3 or greater of the following symptoms which must be present after having been administered a GBCA:

• Cognitive disturbance

• Extremity pain

• Headache

• Chest wall pain

• Skin induration

• Skin hyperpigmentation

• Skin pain

• Arthralgia

Exclusion Criteria:

• 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

• Have had an investigational drug within last 30 days

• Unable to give written consent

• Multiple Sclerosis

• Chronic heart failure

• Cirrhosis of the liver

Related Conditions & MeSH terms

• Arthralgia
• Cognitive Disturbance
• Cognitive Dysfunction
• Headache
• Hyperpigmentation
• Skin Hyperpigmentation

Intervention

Drug:
• Calcium DTPA
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 DTPA
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.

Locations

Country	Name	City	State
United States	UNC Hospitals	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Hameln Pharma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.		Baseline, Month 1
Primary	Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.		Baseline, Month 1
Secondary	Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.		Baseline, Month 2
Secondary	Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.		Baseline, Month 2
Secondary	Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.		Baseline, Month 3
Secondary	Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.		Baseline, Month 3
Secondary	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".	Baseline, Month 1 (Day 7)
Secondary	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".	Baseline, Month 2 (Day 7)
Secondary	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".	Baseline, Month 3 (Day 7)
Secondary	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".	Baseline, Month 6
Secondary	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".	Baseline, Month 12
Secondary	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".	Baseline, Month 1 (day 7)
Secondary	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".	Baseline, Month 2 (day 7)
Secondary	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".	Baseline, Month 3 (day 7)
Secondary	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".	Baseline, Month 6
Secondary	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".	Baseline, Month 12