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Somatostatin Analog

Octreotide capsules for Acromegaly (OPTIMAL Trial)

Phase 3
Waitlist Available
Research Sponsored by Chiasma, Inc.
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 36
Awards & highlights

OPTIMAL Trial Summary

This trial found that octreotide capsules are an effective, long-term treatment for acromegaly.

OPTIMAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.
Secondary outcome measures
Number of Patients Who Begin Rescue Treatment
Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period

OPTIMAL Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Octreotide capsulesActive Control1 Intervention
Octreotide capsules
Group II: Matching PlaceboPlacebo Group1 Intervention
Matching placebo capsules

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Who is running the clinical trial?

Chiasma, Inc.Lead Sponsor
3 Previous Clinical Trials
453 Total Patients Enrolled
3 Trials studying Acromegaly
453 Patients Enrolled for Acromegaly
Susan L Samson, MD PhDStudy ChairPituitary Center at Baylor St. Luke's Medical
~7 spots leftby Jun 2025
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