Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

A Phase 2, Investigator-Initiated, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642550
• Other study ID #: RM-131-005
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2012
• Last updated: September 21, 2016
• Start date: November 2012
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: Motus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• DSM-IV criteria for anorexia nervosa, including weight <85% of ideal body weight (IBW) and amenorrhea for three months;

• Age 18-45 years old;

• Gastrointestinal tract symptoms;

• Non-hormonal method of birth control, which must be used throughout the study. Female patients unable to bear children must have this documented (i.e., tubal ligation, hysterectomy, or post-menopausal, defined as a minimum of one year since the last menstrual period and elevated FSH);

• Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to baseline;

• Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures, including daily SC injections and completion of a daily injection log.

• Patient has a primary care physician or treatment team managing her care.

Exclusion Criteria:

• Use of hormone therapy (including but not limited to estrogen, progesterone) or hormonal methods of birth control (i.e., oral, implantable, or injectable) within eight weeks of screening; or Depo-Provera within six months of screening;

• Pregnancy, lactation or breastfeeding, or a positive serum or urine pregnancy test, within eight weeks of screening;

• History of diabetes mellitus;

• History of purging behaviors greater than once monthly within the last three months;

• Active substance abuse;

• Use of metoclopramide, erythromycin, 5HT3 anti-emetics, or opioid medications within 2 weeks prior to baseline. [Note: these drugs should also not be used post-baseline];

• Hematocrit < 30.0 %, hemoglobin < 10.0 g/dl, potassium < 3.0 mmol/L, fasting glucose > 100 mg/dL, creatinine > 1.5 mg/dL, AST or ALT > 1.5 times the upper limit of normal, or abnormal plasma thyroid stimulating hormone (TSH) level;

• Currently receiving parenteral feeding or enteral feeding, or presence of a nasogastric or other enteral tube for feeding or decompression;

• History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure, small or large bowel resection;

• Clinical suspicion, in the opinion of the investigator, of active or symptomatic peptic ulcer disease, cholelithiasis, colitis, celiac sprue, or inflammatory bowel disease;

• Active suicidal ideation;

• Beck Depression Inventory-2 score of = 29;

• Current inpatient hospitalization;

• Allergic or intolerant of egg, milk, wheat or algae, as these are components of the GEBT test meal;

• Participation in a clinical study with an investigational medication or device within the 30 days prior to dosing in the present study;

• Any other reason, which in the opinion of the Investigator, including severe renal, hepatic or cardiac disease, would confound proper interpretation of the study or expose a patient to unacceptable risk.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Drug:
• RM-131
RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
• Placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Motus Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of RM-131 on body weight	Change from baseline in body weight.	Baseline and Day 28	No
Secondary	Effect of RM-131 on gastric emptying time	Change from baseline in gastric half-emptying time (t1/2).	Baseline and Day 28	No
Secondary	Effect of RM-131 on appetite	Change from baseline in appetite.	Baseline and Day 28	No