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

Sponsor

Motus Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01642550

Collaborator

(none)

Enrollment

Location

Arms

27.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Drug: RM-131 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RM-131 Active study drug - RM-131	Drug: RM-131 RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
Placebo Comparator: Placebo Placebo comparator	Drug: Placebo

Arm

Intervention/Treatment

Active Comparator: RM-131

Active study drug - RM-131

Drug: RM-131

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

Placebo Comparator: Placebo

Placebo comparator

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Effect of RM-131 on body weight [Baseline and Day 28]
Change from baseline in body weight.

Secondary Outcome Measures

Effect of RM-131 on gastric emptying time [Baseline and Day 28]
Change from baseline in gastric half-emptying time (t1/2).
Effect of RM-131 on appetite [Baseline and Day 28]
Change from baseline in appetite.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Motus Therapeutics, Inc.

Investigators

Principal Investigator: Anne Klibanski, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Motus Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT01642550

Other Study ID Numbers:

RM-131-005

First Posted:

Jul 17, 2012

Last Update Posted:

Sep 23, 2016

Last Verified:

Sep 1, 2016

Keywords provided by Motus Therapeutics, Inc.

Anorexia nervosa

Anorexia

Eating disorders

Additional relevant MeSH terms:

Anorexia

Anorexia Nervosa

Study Results

No Results Posted as of Sep 23, 2016