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Somatostatin Analog

CAM2029 (octreotide subcutaneous depot) for Acromegaly (ACROINNOVA 1 Trial)

Q: Are there other similar experiments that have used CAM2029 (octreotide subcutaneous depot)?

CAM2029 (octreotide subcutaneous depot), a medication that was first studied in 1997 at Vanderbilt University Autonomic Dysfunction Center, has had 159 completed studies. As of now, there are 16 live trials with several of them taking place in Ann Arbor, <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a>.

Q: How many people are included in this clinical trial?

In total, this study needs 78 individuals that fit the pre-determined inclusion criteria. These enrollees can come from different hospitals, like University of <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a> in Ann Arbor, Michigan or University of Cincinnati in Cincinnati, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>.

Q: Do most hospitals in this state have access to this trial?

There are 11 enrolment sites for this study, which are currently based in Ann Arbor, Cincinnati and Palo Alto as well as other cities. To limit travel time and requirements, please select the closest centre to you.

Q: Are there any know side-effects to using CAM2029?

CAM2029 (octreotide subcutaneous depot) has received a score of 3 for safety. This is due to the fact that it is a Phase 3 trial, and thus there is some data supporting efficacy as well as multiple rounds of data supporting safety.

Q: What is the main condition that octreotide subcutaneous depot (CAM2029) helps alleviate?

The long-term effects of octreotide, maintenance therapy, and acromegaly can be improved with the help of CAM2029 (octreotide subcutaneous depot).

Q: Are investigators still looking for participants for this research project?

The study, which has been recruiting since 8/14/2019, is still searching for volunteers according to the information available on clinicaltrials.gov.

Phase 3

Waitlist Available

Led By Pamela Freda, M.D

Research Sponsored by Camurus AB

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 22 and 24

Awards & highlights

ACROINNOVA 1 Trial Summary

This trial is to see if a new medication, CAM2029, is effective and safe for people with acromegaly. Patients will be given either the new medication or a placebo once a month for six months.

ACROINNOVA 1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 22 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 22 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 22 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients with mean IGF-1 levels ≤1xULN

Secondary outcome measures

Incidence of treatment emergent adverse events

Octreotide plasma concentrations over time

Proportion of patients with mean GH levels <1.0 µg/L

+4 more

ACROINNOVA 1 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CAM2029 (octreotide subcutaneous depot)Experimental Treatment1 Intervention

CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.

Group II: Matching placeboPlacebo Group1 Intervention

Placebo (subcutaneous depot) 1.0 mL, subcutaneous injection once monthly, six months treatment. If down-titration is required, 0.5 mL dose is available.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CAM2029 (octreotide subcutaneous depot)

2019

Completed Phase 3

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Camurus ABLead Sponsor

8 Previous Clinical Trials

1,790 Total Patients Enrolled

2 Trials studying Acromegaly

147 Patients Enrolled for Acromegaly

Pamela Freda, M.DPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other similar experiments that have used CAM2029 (octreotide subcutaneous depot)?

"CAM2029 (octreotide subcutaneous depot), a medication that was first studied in 1997 at Vanderbilt University Autonomic Dysfunction Center, has had 159 completed studies. As of now, there are 16 live trials with several of them taking place in Ann Arbor, Michigan."

Answered by AI

How many people are included in this clinical trial?

"In total, this study needs 78 individuals that fit the pre-determined inclusion criteria. These enrollees can come from different hospitals, like University of Michigan in Ann Arbor, Michigan or University of Cincinnati in Cincinnati, Ohio."

Answered by AI

Do most hospitals in this state have access to this trial?

"There are 11 enrolment sites for this study, which are currently based in Ann Arbor, Cincinnati and Palo Alto as well as other cities. To limit travel time and requirements, please select the closest centre to you."

Answered by AI

Are there any know side-effects to using CAM2029?

"CAM2029 (octreotide subcutaneous depot) has received a score of 3 for safety. This is due to the fact that it is a Phase 3 trial, and thus there is some data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

What is the main condition that octreotide subcutaneous depot (CAM2029) helps alleviate?

"The long-term effects of octreotide, maintenance therapy, and acromegaly can be improved with the help of CAM2029 (octreotide subcutaneous depot)."

Answered by AI

Are investigators still looking for participants for this research project?

"The study, which has been recruiting since 8/14/2019, is still searching for volunteers according to the information available on clinicaltrials.gov."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

2019. "A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04076462.